How are medical devices classified in India?

Medical devices in India are classified into four risk-based classes under the Medical Devices Rules, 2017: Class A (Low Risk): Tongue depressors, surgical cotton, bandages, examination gloves - require Registration Certificate Class B (Low-Moderate Risk): Hypodermic needles, suction equipment, blood collection tubes, powered wheelchairs - require Registration Certificate Class C (Moderate-High Risk): Haemodialysis catheters, ventilators, bone fixation plates, condoms - require Import/Manufacturing Licence Class D (High Risk): Heart valves, coronary stents, pacemakers, breast implants - require Import/Manufacturing Licence Higher-risk classes require more stringent documentation, clinical evidence, and quality management compliance.

Who needs CDSCO Medical Device Registration?

All entities involved in the medical device supply chain in India must obtain CDSCO Medical Device Registration : Indian Manufacturers: Companies manufacturing medical devices in India for domestic sale or export Importers: Companies importing medical devices into India from foreign manufacturers Foreign Manufacturers: Through their authorised Indian agent for registration Software Developers: Companies developing Software as Medical Device (SaMD) for clinical use In-Vitro Diagnostic (IVD) Manufacturers: Companies making diagnostic test kits and reagents Exemptions apply only to devices manufactured solely for export and devices under custom-made or investigational use categories.

What is the SUGAM portal for medical device registration?

The SUGAM portal (sugam.cdsco.gov.in) is the official online platform of CDSCO for filing medical device registration and licensing applications. All applications - whether for manufacturing licence, import licence, registration certificate, or clinical trial approval - must be submitted electronically through SUGAM. The portal provides: Online application submission with digital document uploads Real-time application tracking and status updates Fee payment through integrated payment gateway Communication with CDSCO officials for query resolution Certificate download upon approval At IncorpX , we handle the complete SUGAM portal filing process for you.

What is a Device Master File (DMF)?

A Device Master File (DMF) is a comprehensive technical dossier that contains all information about the design, manufacturing, and performance of a medical device. It is a critical document required for CDSCO registration and includes: Device Description: Intended use, indications, contraindications, and specifications Design & Manufacturing: Materials, design verification, manufacturing process, sterilisation Quality Management: ISO 13485 certification, quality control procedures Performance Data: Biocompatibility, electrical safety, performance testing results Clinical Evidence: Clinical investigation data or literature-based clinical evaluation Labelling & IFU: Label content, instructions for use, packaging details The DMF must demonstrate that the device is safe and effective for its intended purpose.

What is the difference between CDSCO and State Drug Controller?

Both CDSCO (central) and State Drug Controllers (state-level) play roles in medical device regulation, but with distinct responsibilities: CDSCO (Central): Grants import licences for all classes, manufacturing licences for Class C & D devices, approves clinical investigations, sets regulatory standards, and issues registration certificates State Drug Controller: Grants manufacturing licences for Class A & B devices, conducts factory inspections, monitors post-market compliance, and enforces regulations at the state level For import licences , all applications go to CDSCO regardless of device class. For manufacturing licences , Class A & B go to the State, while Class C & D go to CDSCO.

What is the registration process for medical devices in India?

The step-by-step process for Medical Device Registration in India through the SUGAM portal is: Step 1: Determine device classification (Class A/B/C/D) based on risk assessment Step 2: Prepare the Device Master File (DMF) and technical documentation Step 3: Obtain ISO 13485 certification for quality management system Step 4: Create account and file application on SUGAM portal (sugam.cdsco.gov.in) Step 5: Upload all technical documents and pay the prescribed fees Step 6: CDSCO reviews the application and may raise queries Step 7: Address CDSCO queries with additional documentation or clarifications Step 8: Grant of Registration Certificate or Licence upon approval The process typically takes 6-12 months depending on device class and completeness of documentation. At IncorpX , we handle the entire process for you.

What documents are required for medical device registration?

The following documents are required for CDSCO Medical Device Registration: Device Master File (DMF): Complete technical dossier covering design, manufacturing, and performance Quality Management System: ISO 13485 certificate from an accredited certification body Test Reports: Biocompatibility, electrical safety, performance, and stability testing reports from accredited labs Clinical Data: Clinical investigation report or clinical evaluation based on published literature Free Sale Certificate (FSC): For imported devices - certificate from the country of origin confirming the device is approved for sale Certificate of Analysis (CoA): Batch-wise quality analysis reports Labelling & IFU: Device labels and instructions for use in English and Hindi Manufacturing Licence: State Drug Controller licence (for Indian manufacturers of Class A/B) Authorised Agent Letter: For foreign manufacturers, appointing an Indian authorised agent

What is the difference between Manufacturing Licence and Import Licence?

The two main licence types under the Medical Devices Rules, 2017 are: Manufacturing Licence: Required for companies manufacturing medical devices in India. Class A & B licences are issued by the State Drug Controller; Class C & D licences are issued by CDSCO. Requires factory premises inspection, GMP compliance, and ISO 13485 certification. Import Licence: Required for importing medical devices into India from foreign manufacturers. All import licences (Class A to D) are issued by CDSCO. Requires Free Sale Certificate from the country of origin, authorised Indian agent appointment, and full technical documentation. A single entity can hold both manufacturing and import licences for different devices. The regulatory burden increases with device risk class.

What are the CDSCO registration fees for medical devices?

The CDSCO registration fees for medical devices vary by device class and licence type: Class A & B Registration Certificate: ₹3,000 to ₹5,000 per device (government fees) Class C & D Manufacturing Licence: ₹10,000 to ₹50,000 per device (government fees) Import Licence (All Classes): ₹10,000 to ₹50,000 per device (government fees) Clinical Investigation Permission: ₹50,000 per study Retention/Renewal Fee: Annual fees for maintaining active registration Professional service fees for documentation, DMF preparation, and regulatory consulting are additional. At IncorpX , our comprehensive registration package starts at ₹24,999 , covering documentation, SUGAM portal filing, and CDSCO follow-up.

What is clinical investigation for medical devices?

A clinical investigation is a systematic study conducted on human subjects to evaluate the safety and performance of a medical device under controlled conditions. Under the Medical Devices Rules, 2017: Mandatory for: Class C and Class D medical devices (moderate-high and high risk) Permission Required: Prior approval from CDSCO and Ethics Committee Site Requirements: Must be conducted at approved clinical investigation sites in India Data Requirements: Safety endpoints, performance endpoints, adverse event reporting Exemptions: May be waived if substantial clinical evidence from other countries exists For Class A and B devices, clinical investigation is generally not required unless the device has a novel intended use or technology.

What is the role of a Notified Body in medical device registration?

A Notified Body is an organisation designated by the regulatory authority to assess the conformity of medical devices with applicable standards. In the Indian context: Quality Audits: Notified Bodies conduct audits of the manufacturer's quality management system (ISO 13485 compliance) Product Testing: They verify that the device meets applicable Indian Standards and performance requirements Certification: They issue conformity certificates that are submitted as part of the CDSCO registration dossier Surveillance: They conduct periodic surveillance audits to ensure continued compliance While India does not have a formal Notified Body system identical to the EU, CDSCO-recognised third-party testing labs and BIS-accredited bodies serve a similar function for device evaluation.

How long does CDSCO medical device registration take?

The processing timeline depends on the device class and documentation completeness: Class A Registration: 3-6 months Class B Registration: 4-8 months Class C Licence: 6-12 months Class D Licence: 9-18 months Import Licence: 6-12 months (all classes) Clinical Investigation Approval: 3-6 months additional Delays commonly occur due to incomplete documentation, CDSCO queries, or pending test reports. At IncorpX , we minimise delays through thorough documentation preparation and proactive CDSCO query management.

Is ISO 13485 certification mandatory for medical device registration?

ISO 13485 (Quality Management Systems for Medical Devices) certification is mandatory for all medical device manufacturers applying for CDSCO registration. Key requirements: The certification must be from an accredited certification body The scope must cover the specific medical device being registered The certification must be valid at the time of application and throughout the licence period For imported devices, the foreign manufacturer must hold ISO 13485 certification IncorpX also provides ISO Certification services to help manufacturers meet this mandatory requirement before filing for CDSCO registration.

What are the penalties for selling unregistered medical devices in India?

Under the Drugs & Cosmetics Act, 1940 and the Medical Devices Rules, 2017 , severe penalties apply for non-compliance: Manufacturing/Importing without licence: Imprisonment up to 3 years and fine up to ₹5 lakhs Selling unregistered devices: Imprisonment up to 3 years and fine up to ₹1 lakh Misbranded/Adulterated devices: Imprisonment up to 5 years and fine up to ₹10 lakhs Spurious devices: Imprisonment up to 10 years and fine up to ₹10 lakhs or three times the value , whichever is more CDSCO conducts regular surveillance and enforcement drives. All medical devices in India must carry valid registration/licence numbers.

What is a Free Sale Certificate and when is it needed?

A Free Sale Certificate (FSC) is an official document issued by the regulatory authority of the country of origin confirming that a medical device is approved for sale and use in that country. It is mandatory for all imported medical devices seeking registration in India. The FSC must: Be issued by the national regulatory authority (e.g., FDA for USA, TGA for Australia, MHRA for UK) Clearly identify the device by name, model, and intended use Be authenticated or apostilled as per Indian requirements Be valid at the time of application submission For devices approved in countries with recognised regulatory frameworks (US FDA, EU CE, Japan PMDA, Australia TGA), expedited review pathways may be available.

What is the Medical Devices (Amendment) Rules, 2020?

The Medical Devices (Amendment) Rules, 2020 was a significant regulatory update that expanded the scope of medical device regulation in India. Key changes include: Universal Registration: All medical devices - not just those notified individually - were brought under mandatory registration Risk-Based Classification: Reinforced the Class A-D risk-based classification system Timeline for Compliance: Set phased deadlines for existing device manufacturers to obtain registration Price Control: Certain devices brought under NPPA (National Pharmaceutical Pricing Authority) price caps Import Monitoring: Strengthened documentation requirements for imported devices This amendment significantly increased the regulatory compliance burden on medical device companies operating in India.

CDSCO Medical Device Registration

Medical Device Registration in India

Get Your CDSCO Medical Device Registration Under Medical Devices Rules 2017 - Starting @ ₹24,999 Only

Class A to D Devices. Manufacturing & Import Licences. End-to-End SUGAM Portal Filing.

Device Classification Assessment
Device Master File Preparation
SUGAM Portal Filing
Manufacturing & Import Licence
Clinical Investigation Support
CDSCO Query Management

FREE Consultation Get Started @ ~~₹299~~ ₹0

Get Expert Consultation

Talk to our business executives in minutes

Instant Response 100% Confidential Expert Advice

What Sets Us Apart

500+ Medical Devices Registered

97% Approval Rate

Expert Regulatory Consultants

Companies Incorporated

Successfully incorporated across India

Client Satisfaction

Rated excellent by our customers

Years of Experience

Serving businesses since 2020

Expert Consultants

Specialists in company formation

Testimonials

Hear What Our Customers Have to Say

India's one of the highest-rated legal tax and compliance guidance platform.

4.9 out of 5 (8521+ ratings)

Verified

Siddhu Manoj Founder & CEO of Two-LYP Computations Pvt. Ltd.

“Incorporating my Startup with IncorpX was an incredibly smooth and hassle-free experience. The team was highly professional, guiding us every step of the way with clear communication and prompt support. The registration process was fast, and every detail was handled with precision and accuracy. Highly recommend IncorpX for anyone starting a business.”

Abhishek Lohani Director at Lohani Learnings

“Company is good and service is also smooth. I used their compliance service and the response was timely with no delay and price are also convenient. They are always available to cater your need.”

Chandan Kr. Chaudhary Founder of Creative Minds

“I am very satisfied with the team of IncorpX for providing the top notch services. Team of IncorpX was giving the update on daily basis was one of the best thing which I experience in Corporate. keep doing it. Thank you!”

Jayavijaya SJ Founder of Agro Farms

“Don't think twice.Got my company incorporates here. Tbh very impressed by the quality of service provided by this team. Very organized and friendly team. Had a smooth and peaceful experience. Timely regular updates were provided by the team. Overall a great experience.”

Anoop Krishnan Founder of EIGHTH DAY FORGE

“It's rare to find a service provider who makes the process feel personal - IncorpX absolutely did. From day one, they patiently explained every detail without any jargon, making it easy to understand and stress-free. There was zero chasing, no delays-just efficient, smooth execution all the way through. I felt supported, heard, and confident at every step of registering my company EIGHTH DAY FORGE (OPC) Private Limited. Thanks to Mr. Sriram and his wonderful team.”

Ramesh Lanke Founder of EKnal Technologies

“IncorpX made the entire registration process for our company, EKnal Technologies, smooth and stress-free. Their team was professional, efficient, and incredibly supportive from start to finish. Highly recommend them to any founder looking for a reliable partner in their business journey! Special shoutout to Sriram and Aswin-your support, clarity, and responsiveness made the whole process incredibly smooth.”

700+

Businesses Incorporated Every Month

1000+

Ratings Trusted by 2000+ Clients

250+

Professional Network

Why Choose Us

Why Choose Us?

Expert Legal Team

Experienced legal experts in company formation and corporate law.

Fast Turnaround

Kickstart your venture with efficient company setup, generally processed within a week.

Dedicated Support

Personal manager by your side, every step of the way and beyond.

Complete Documentation

We handle all paperwork and ensure full legal compliance.

Business Growth Tools

Free business resources to fuel your company's success from day one.

24/7 Customer Service

Round-the-clock assistance for all your concerns.

Simple Process

Here's How It Works

Fill the Form

Simply fill the above form to get started.

Call to discuss

Our startup expert will connect with you & complete legalities.

Get Your CDSCO Registration Done

Our regulatory experts handle the complete Medical Device Registration process - from classification to licence grant.

Pricing

Simple & Transparent Pricing

Medical Device Registration Package

From ₹24999 one-time professional fee

Complete within 7 days

7-day turnaround 100% guaranteed

Free Consultation & Classification
Regulatory Strategy Planning
Device Master File Preparation
ISO 13485 Guidance
SUGAM Portal Filing
Document Preparation & Upload
Fee Payment Assistance
CDSCO Query Resolution
Registration Certificate/Licence
Post-Market Compliance Guidance

*Government fees are additional and vary based on company structure

4.9/5 based on 1000+ reviews

Money back guarantee

Secure payment

Top rated service

AI-Powered Platform

Meet IncorpX Nova

Our proprietary AI engine streamlines every step of business setup, from intelligent name suggestions to automated document drafting and compliance tracking.

AI-Powered Business Name Approval Check
Auto-Generated MoA & AoA Drafts
Real-Time Compliance Monitoring
3x Faster Processing Than Traditional CAs
24/7 AI Chatbot + Human Expert Support

NOVA AI

Premium Plan

IncorpX Prime

An all-inclusive solution for startups and expanding enterprises seeking a streamlined, compliant incorporation process.

Key Benefits

Personalised support from dedicated incorporation specialists.
Application prepared and filed within 2 days.
24/7 customer assistance.

Important Notes

We strive to register your preferred business name whenever feasible.
Alternative name suggestions are provided if the preferred name is not approved.

Package includes first-year compliance services: auditor appointment, annual filings, and related obligations.

Overview Classification Who Needs CDSCO vs State Process Documents Licence Types Clinical Fees & Timeline FAQs

MEDICAL DEVICE REGISTRATION - AN OVERVIEW

Medical Device Registration is the mandatory regulatory approval process administered by the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare (MoHFW), Government of India. It authorises the manufacture, import, sale, and distribution of medical devices in India under the comprehensive Medical Devices Rules, 2017 - notified under the Drugs & Cosmetics Act, 1940.

The Medical Devices Rules, 2017 - which came into effect on 1 January 2018 - established a dedicated regulatory framework for medical devices separate from pharmaceuticals. Under this framework, every medical device must be classified into one of four risk-based categories (Class A, B, C, or D) and must obtain either a Registration Certificate or a Manufacturing/Import Licence from CDSCO before it can be legally marketed in India.

The Medical Devices (Amendment) Rules, 2020 further strengthened this framework by bringing all medical devices under mandatory registration - not just those individually notified. This means every instrument, apparatus, appliance, implant, software, material, or reagent intended for medical use must now be registered with CDSCO, making regulatory compliance an absolute necessity for all stakeholders in the medical device industry.

At IncorpX, we provide comprehensive Medical Device Registration services covering the entire regulatory lifecycle - from device classification and Device Master File preparation to SUGAM portal filing, clinical investigation support, and CDSCO query management. Our packages start at just ₹24,999.

What is Medical Device Registration?

Medical Device Registration (also called CDSCO Registration, Medical Device Licence, or MD Registration) is the official regulatory approval granted by the Central Drugs Standard Control Organisation (CDSCO) that permits a medical device to be legally manufactured, imported, sold, and distributed in India. It is governed by the Medical Devices Rules, 2017 and amendments thereto, notified under the Drugs & Cosmetics Act, 1940.

The registration process involves comprehensive evaluation of the device's safety, performance, and quality - including review of the Device Master File (DMF), quality management system (ISO 13485), test reports from accredited laboratories, clinical data, and labelling. The rigour of the evaluation increases with the device's risk classification - from Class A (low risk) to Class D (high risk).

All applications are filed electronically through the SUGAM portal (sugam.cdsco.gov.in), CDSCO's official online platform for regulatory submissions. The registration is valid for 5 years and must be renewed before expiry to continue marketing the device in India.

Key Aspects of Medical Device Registration:

CDSCO Approval: Official regulatory clearance from India's national medical device authority under MoHFW.
Risk-Based Classification: Devices classified into Class A (low risk) to Class D (high risk) - each with different regulatory pathways.
Quality Assurance: ISO 13485 certification and GMP compliance are mandatory prerequisites for all manufacturers.
5-Year Validity: Registration Certificates and Licences are valid for 5 years with annual retention fees and renewal before expiry.

Did You Know?

Selling unregistered medical devices in India is a punishable offence under the Drugs & Cosmetics Act, 1940 - attracting imprisonment up to 3 years and fines up to ₹5,00,000. For spurious medical devices, penalties can extend to 10 years imprisonment. CDSCO conducts regular market surveillance drives to enforce compliance.

Classification of Medical Devices (Class A/B/C/D):

Medical devices in India are classified into four risk-based categories under the Medical Devices Rules, 2017. The classification determines the regulatory pathway, documentation requirements, and the authority responsible for granting the licence.

Device Class	Risk Level	Examples	Regulatory Requirement	Licensing Authority
Class A	Low Risk	Tongue depressors, surgical cotton, bandages, examination gloves, wheelchairs (non-powered)	Registration Certificate	State Drug Controller (Manufacturing) / CDSCO (Import)
Class B	Low-Moderate Risk	Hypodermic needles, suction equipment, blood collection tubes, powered wheelchairs, surgical drapes	Registration Certificate	State Drug Controller (Manufacturing) / CDSCO (Import)
Class C	Moderate-High Risk	Haemodialysis catheters, ventilators, bone fixation plates, condoms, contact lenses, infusion pumps	Manufacturing / Import Licence	CDSCO (both Manufacturing & Import)
Class D	High Risk	Heart valves, coronary stents, pacemakers, breast implants, hip prostheses, defibrillators	Manufacturing / Import Licence	CDSCO (both Manufacturing & Import)

Important Note!

Device classification is based on the intended use, duration of contact, degree of invasiveness, and dependence on a source of energy. A device may be classified differently if its intended use changes. Incorrect classification can lead to application rejection by CDSCO. In-Vitro Diagnostic (IVD) devices follow a separate classification system (Class A to D for IVDs) under the same rules.

Who Needs CDSCO Registration?

All entities involved in the medical device supply chain in India must obtain CDSCO registration or licensing. Here's who needs to register:

1. Indian Manufacturers

Companies manufacturing medical devices in India for domestic sale or export. Need Manufacturing Licence from State Drug Controller (Class A/B) or CDSCO (Class C/D).

2. Importers

Companies importing medical devices into India from foreign manufacturers. All import licences (Class A to D) are granted by CDSCO.

3. Foreign Manufacturers

International device companies must register through an Authorised Indian Agent who acts as the licence holder and regulatory point of contact.

4. SaMD Developers

Companies developing Software as Medical Device (SaMD) for clinical diagnosis, monitoring, or treatment purposes - regulated as medical devices.

5. IVD Manufacturers

Companies making In-Vitro Diagnostic devices including diagnostic test kits, reagents, calibrators, and sample collection devices.

6. Distributors & Dealers

Wholesale and retail distributors of medical devices must ensure they deal only in registered/licensed devices and maintain traceability records.

CDSCO vs State Drug Controller - Who Regulates What?

Medical device regulation in India involves both the central authority (CDSCO) and state-level authorities (State Drug Controllers). Understanding their respective roles is crucial for filing applications with the correct authority.

Aspect	CDSCO (Central)	State Drug Controller (State)
Authority	Central Drugs Standard Control Organisation under MoHFW	State Drug Controlling Authority under respective State Government
Manufacturing Licence	Class C & Class D medical devices	Class A & Class B medical devices
Import Licence	All classes (A, B, C & D)	Not applicable - all imports go through CDSCO
Clinical Investigation	Grants permission for clinical investigations in India	No role in clinical investigation approval
Factory Inspection	Inspects factories for Class C/D devices	Inspects factories for Class A/B devices
Post-Market Surveillance	Sets national policies, coordinates recalls	Enforces compliance, monitors market at state level
Standards & Policy	Sets regulatory standards, classification rules, and guidelines	Implements central policies at state level

Note: For import licences, all applications - regardless of device class - must be filed with CDSCO. For manufacturing licences, the authority depends on the device class. At IncorpX, we handle applications with both CDSCO and State Drug Controllers across India for complete licensing and registration support.

Step-by-Step Registration Process for Medical Devices:

All medical device applications are filed electronically through the CDSCO SUGAM portal. At IncorpX, we handle the complete process on your behalf. Here's the step-by-step procedure:

Step 1: Device Classification & Regulatory Strategy

Determine the risk-based classification of your medical device (Class A, B, C, or D) under the Medical Devices Rules, 2017. This classification determines whether you need a Registration Certificate or a Manufacturing/Import Licence, and which authority to approach. Our regulatory experts provide a free classification assessment.

Step 2: Prepare Device Master File (DMF)

Compile the comprehensive Device Master File including device description, intended use, design specifications, materials of construction, manufacturing process, sterilisation validation, biocompatibility data, electrical safety reports, and performance testing results. The DMF is the cornerstone of your CDSCO application.

Step 3: Obtain ISO 13485 Certification & Test Reports

Obtain ISO 13485 Quality Management System certification from an accredited body. Commission biocompatibility, electrical safety, and performance testing from accredited laboratories. For imported devices, obtain a Free Sale Certificate (FSC) from the country of origin's regulatory authority.

Step 4: Conduct Clinical Investigation (Class C & D)

For Class C and D devices, obtain CDSCO permission and Ethics Committee approval for clinical investigation in India. Conduct the study at approved sites, collect safety and performance data, and prepare the clinical investigation report. Class A/B devices may rely on literature-based clinical evaluation.

Step 5: File Application on SUGAM Portal

Create an account on the CDSCO SUGAM portal (sugam.cdsco.gov.in). Complete the online application form, upload all technical documents, and pay the prescribed government fees. Our team ensures all documents meet CDSCO format requirements for smooth processing.

Step 6: CDSCO Review & Query Resolution

CDSCO reviewers evaluate the application and technical documentation. They may raise queries requiring additional data, clarifications, or test reports. IncorpX manages the complete query resolution process to minimise delays and ensure timely approval.

Step 7: Grant of Registration Certificate / Licence

Upon successful review, CDSCO grants the Registration Certificate (Class A/B) or Manufacturing/Import Licence (Class C/D). The certificate is downloadable from the SUGAM portal. Valid for 5 years. The entire process typically takes 6-12 months depending on device class and documentation completeness.

Get your Medical Device Registration in 6-12 months with IncorpX!

What Are the Documents Required for Medical Device Registration?

The documents required for CDSCO Medical Device Registration vary based on the device class and whether it is domestically manufactured or imported. Here's a comprehensive list:

Category	Document Type	Specific Requirements	Applicable For
Device Master File (DMF)	Device Description	Intended use, indications, contraindications, technical specifications, materials of construction	All Classes (A-D)
	Design & Manufacturing	Design verification/validation, manufacturing process, sterilisation method, packaging details	All Classes (A-D)
	Labelling & IFU	Device labels, Instructions for Use in English & Hindi, packaging inserts	All Classes (A-D)
Quality Management	ISO 13485 Certificate	Quality Management System certification from accredited body covering the specific device	All Classes (A-D)
Quality Management	GMP Compliance	Good Manufacturing Practice documentation, quality control procedures, batch records	Manufacturing Licence
Test Reports	Biocompatibility	ISO 10993 biocompatibility evaluation - cytotoxicity, sensitisation, irritation, systemic toxicity	Class B, C, D
	Electrical Safety	IEC 60601 electrical safety testing for electrically powered devices	Electrically powered devices
	Performance Testing	Device-specific performance testing, stability studies, shelf-life validation	All Classes (A-D)
Clinical Evidence	Clinical Investigation Report	Safety and performance data from clinical studies conducted on human subjects in India	Class C & D (mandatory)
Clinical Evidence	Clinical Evaluation Report	Literature-based evaluation of clinical safety and performance from published studies	Class A & B (or Class C/D with waiver)
Import-Specific Documents	Free Sale Certificate (FSC)	Certificate from country of origin confirming device is approved for sale (authenticated/apostilled)	Imported devices only
Import-Specific Documents	Authorised Agent Letter	Appointment of authorised Indian agent by the foreign manufacturer	Imported devices only

Manufacturing Licence vs Import Licence for Medical Devices:

The Medical Devices Rules, 2017 define two primary licence categories based on the origin of the device. Understanding the differences helps you identify the correct regulatory pathway.

Aspect	Manufacturing Licence	Import Licence
Who Applies	Indian companies manufacturing devices domestically	Companies importing devices from foreign manufacturers
Licensing Authority	State Drug Controller (Class A/B) or CDSCO (Class C/D)	CDSCO (all classes - A, B, C & D)
Factory Inspection	Mandatory - premises inspection by licensing authority	Not applicable for Indian premises; foreign manufacturer site audit may be conducted
ISO 13485	Indian manufacturer must hold ISO 13485 certification	Foreign manufacturer must hold ISO 13485 certification
Free Sale Certificate	Not required	Mandatory - from country of origin regulatory authority
Authorised Agent	Not required - manufacturer applies directly	Mandatory - foreign manufacturer must appoint Indian authorised agent
Key Advantage	Direct control over manufacturing and quality; "Make in India" benefits	Access to global medical technology; faster market entry for established devices

Note: A single entity can hold both manufacturing and import licences for different devices. IncorpX provides end-to-end assistance for both licence types, including coordination with State Drug Controllers for manufacturing licences and CDSCO for import licences. Need a Drug & Cosmetic Licence alongside? We handle that too.

Clinical Investigation Requirements for Medical Devices:

Clinical investigation is a critical component of the regulatory pathway for higher-risk medical devices. Here's what you need to know:

Class C & D devices - Clinical investigation is generally mandatory unless a waiver is granted based on existing evidence

Prior approval required - CDSCO permission and Ethics Committee approval must be obtained before starting

Approved sites only - Clinical investigations must be conducted at CDSCO-approved clinical investigation sites in India

Protocol requirements - Detailed study protocol including objectives, endpoints, sample size, and statistical analysis plan

Informed consent - Written informed consent from all study participants in local language and English

Adverse event reporting - All serious adverse events must be reported to CDSCO and Ethics Committee within prescribed timelines

Waiver possibility - CDSCO may waive clinical investigation if substantial evidence from recognised regulatory jurisdictions (US FDA, EU, Japan PMDA, Australia TGA) exists

Class A & B devices - Clinical investigation is generally not required; literature-based clinical evaluation is acceptable

Important Note!

The Medical Devices Rules, 2017 require that clinical investigations follow ISO 14155 (Clinical Investigation of Medical Devices for Human Subjects - Good Clinical Practice). All investigators must be qualified medical professionals. IncorpX provides guidance on clinical investigation design, Ethics Committee submissions, and regulatory documentation.

Fees & Timeline for Medical Device Registration:

CDSCO registration fees and processing timelines vary by device class and licence type. Here's a comprehensive overview:

Device Class / Licence Type	Government Fee (Approx.)	Processing Timeline	Validity
Class A - Registration Certificate	₹3,000 - ₹5,000 per device	3-6 months	5 years
Class B - Registration Certificate	₹5,000 - ₹10,000 per device	4-8 months	5 years
Class C - Manufacturing/Import Licence	₹10,000 - ₹30,000 per device	6-12 months	5 years
Class D - Manufacturing/Import Licence	₹25,000 - ₹50,000 per device	9-18 months	5 years
Import Licence (All Classes)	₹10,000 - ₹50,000 per device	6-12 months	5 years
Clinical Investigation Permission	₹50,000 per study	3-6 months	Study-specific
Annual Retention Fee	₹1,000 - ₹5,000	Annual	Per year

Note: Government fees are subject to revision by CDSCO. Professional service fees for DMF preparation, regulatory consulting, SUGAM portal filing, and query management are additional. At IncorpX, our comprehensive Medical Device Registration package starts at ₹24,999 covering documentation, filing, and end-to-end support.

Custom pricing based on your device class and requirements!

Why Choose IncorpX for Medical Device Registration?

End-to-End Service: From device classification to licence grant - we handle the complete CDSCO registration process.

Transparent Pricing: No hidden charges. Comprehensive packages starting at ₹24,999.

Minimised Timelines: Expert DMF preparation and proactive query management to reduce delays.

Regulatory Experts: Dedicated team experienced in CDSCO regulations, medical device law, and clinical investigations.

Complete Documentation: Device Master File, test report coordination, clinical evaluation, and SUGAM portal filing.

Lifecycle Support: Registration renewal, post-market surveillance guidance, and regulatory updates.

FAQs on Medical Device Registration

Understanding CDSCO Medical Device Registration requirements can be complex due to evolving rules and class-wise compliance norms. We've compiled answers to the most frequently asked questions to help you navigate the process.

Whether you're a manufacturer registering a new device or an importer seeking an import licence, these FAQs cover everything about Medical Device Registration in India.

CDSCO Medical Device Registration is the mandatory regulatory approval process administered by the Central Drugs Standard Control Organisation (CDSCO) under the Medical Devices Rules, 2017. It authorises the manufacture, import, sale, and distribution of medical devices in India. Every medical device - from simple bandages (Class A) to life-supporting implants (Class D) - must be registered with CDSCO before it can be marketed in India. At IncorpX, we provide end-to-end Medical Device Registration services starting at just ₹24,999.

The Medical Devices Rules, 2017 were notified under the Drugs & Cosmetics Act, 1940 and came into effect from 1 January 2018. These rules provide a comprehensive regulatory framework for medical devices in India - separate from the drug regulation framework. They cover device classification (Class A to D based on risk), registration and licensing requirements, quality management system standards, clinical investigation norms, labelling requirements, and post-market surveillance obligations. The Medical Devices (Amendment) Rules, 2020 further strengthened the framework by bringing all medical devices under mandatory registration.

Medical devices in India are classified into four risk-based classes under the Medical Devices Rules, 2017:

Class A (Low Risk): Tongue depressors, surgical cotton, bandages, examination gloves - require Registration Certificate
Class B (Low-Moderate Risk): Hypodermic needles, suction equipment, blood collection tubes, powered wheelchairs - require Registration Certificate
Class C (Moderate-High Risk): Haemodialysis catheters, ventilators, bone fixation plates, condoms - require Import/Manufacturing Licence
Class D (High Risk): Heart valves, coronary stents, pacemakers, breast implants - require Import/Manufacturing Licence

Higher-risk classes require more stringent documentation, clinical evidence, and quality management compliance.

All entities involved in the medical device supply chain in India must obtain CDSCO Medical Device Registration:

Indian Manufacturers: Companies manufacturing medical devices in India for domestic sale or export
Importers: Companies importing medical devices into India from foreign manufacturers
Foreign Manufacturers: Through their authorised Indian agent for registration
Software Developers: Companies developing Software as Medical Device (SaMD) for clinical use
In-Vitro Diagnostic (IVD) Manufacturers: Companies making diagnostic test kits and reagents

Exemptions apply only to devices manufactured solely for export and devices under custom-made or investigational use categories.

The SUGAM portal (sugam.cdsco.gov.in) is the official online platform of CDSCO for filing medical device registration and licensing applications. All applications - whether for manufacturing licence, import licence, registration certificate, or clinical trial approval - must be submitted electronically through SUGAM. The portal provides:

Online application submission with digital document uploads
Real-time application tracking and status updates
Fee payment through integrated payment gateway
Communication with CDSCO officials for query resolution
Certificate download upon approval

At IncorpX, we handle the complete SUGAM portal filing process for you.

A Device Master File (DMF) is a comprehensive technical dossier that contains all information about the design, manufacturing, and performance of a medical device. It is a critical document required for CDSCO registration and includes:

Device Description: Intended use, indications, contraindications, and specifications
Design & Manufacturing: Materials, design verification, manufacturing process, sterilisation
Quality Management: ISO 13485 certification, quality control procedures
Performance Data: Biocompatibility, electrical safety, performance testing results
Clinical Evidence: Clinical investigation data or literature-based clinical evaluation
Labelling & IFU: Label content, instructions for use, packaging details

The DMF must demonstrate that the device is safe and effective for its intended purpose.

Both CDSCO (central) and State Drug Controllers (state-level) play roles in medical device regulation, but with distinct responsibilities:

CDSCO (Central): Grants import licences for all classes, manufacturing licences for Class C & D devices, approves clinical investigations, sets regulatory standards, and issues registration certificates
State Drug Controller: Grants manufacturing licences for Class A & B devices, conducts factory inspections, monitors post-market compliance, and enforces regulations at the state level

For import licences, all applications go to CDSCO regardless of device class. For manufacturing licences, Class A & B go to the State, while Class C & D go to CDSCO.

The step-by-step process for Medical Device Registration in India through the SUGAM portal is:

Step 1: Determine device classification (Class A/B/C/D) based on risk assessment
Step 2: Prepare the Device Master File (DMF) and technical documentation
Step 3: Obtain ISO 13485 certification for quality management system
Step 4: Create account and file application on SUGAM portal (sugam.cdsco.gov.in)
Step 5: Upload all technical documents and pay the prescribed fees
Step 6: CDSCO reviews the application and may raise queries
Step 7: Address CDSCO queries with additional documentation or clarifications
Step 8: Grant of Registration Certificate or Licence upon approval

The process typically takes 6-12 months depending on device class and completeness of documentation. At IncorpX, we handle the entire process for you.

The following documents are required for CDSCO Medical Device Registration:

Device Master File (DMF): Complete technical dossier covering design, manufacturing, and performance
Quality Management System: ISO 13485 certificate from an accredited certification body
Test Reports: Biocompatibility, electrical safety, performance, and stability testing reports from accredited labs
Clinical Data: Clinical investigation report or clinical evaluation based on published literature
Free Sale Certificate (FSC): For imported devices - certificate from the country of origin confirming the device is approved for sale
Certificate of Analysis (CoA): Batch-wise quality analysis reports
Labelling & IFU: Device labels and instructions for use in English and Hindi
Manufacturing Licence: State Drug Controller licence (for Indian manufacturers of Class A/B)
Authorised Agent Letter: For foreign manufacturers, appointing an Indian authorised agent

The two main licence types under the Medical Devices Rules, 2017 are:

Manufacturing Licence: Required for companies manufacturing medical devices in India. Class A & B licences are issued by the State Drug Controller; Class C & D licences are issued by CDSCO. Requires factory premises inspection, GMP compliance, and ISO 13485 certification.
Import Licence: Required for importing medical devices into India from foreign manufacturers. All import licences (Class A to D) are issued by CDSCO. Requires Free Sale Certificate from the country of origin, authorised Indian agent appointment, and full technical documentation.

A single entity can hold both manufacturing and import licences for different devices. The regulatory burden increases with device risk class.

The CDSCO registration fees for medical devices vary by device class and licence type:

Class A & B Registration Certificate: ₹3,000 to ₹5,000 per device (government fees)
Class C & D Manufacturing Licence: ₹10,000 to ₹50,000 per device (government fees)
Import Licence (All Classes): ₹10,000 to ₹50,000 per device (government fees)
Clinical Investigation Permission: ₹50,000 per study
Retention/Renewal Fee: Annual fees for maintaining active registration

Professional service fees for documentation, DMF preparation, and regulatory consulting are additional. At IncorpX, our comprehensive registration package starts at ₹24,999, covering documentation, SUGAM portal filing, and CDSCO follow-up.

A clinical investigation is a systematic study conducted on human subjects to evaluate the safety and performance of a medical device under controlled conditions. Under the Medical Devices Rules, 2017:

Mandatory for: Class C and Class D medical devices (moderate-high and high risk)
Permission Required: Prior approval from CDSCO and Ethics Committee
Site Requirements: Must be conducted at approved clinical investigation sites in India
Data Requirements: Safety endpoints, performance endpoints, adverse event reporting
Exemptions: May be waived if substantial clinical evidence from other countries exists

For Class A and B devices, clinical investigation is generally not required unless the device has a novel intended use or technology.

A Notified Body is an organisation designated by the regulatory authority to assess the conformity of medical devices with applicable standards. In the Indian context:

Quality Audits: Notified Bodies conduct audits of the manufacturer's quality management system (ISO 13485 compliance)
Product Testing: They verify that the device meets applicable Indian Standards and performance requirements
Certification: They issue conformity certificates that are submitted as part of the CDSCO registration dossier
Surveillance: They conduct periodic surveillance audits to ensure continued compliance

While India does not have a formal Notified Body system identical to the EU, CDSCO-recognised third-party testing labs and BIS-accredited bodies serve a similar function for device evaluation.

The processing timeline depends on the device class and documentation completeness:

Class A Registration: 3-6 months
Class B Registration: 4-8 months
Class C Licence: 6-12 months
Class D Licence: 9-18 months
Import Licence: 6-12 months (all classes)
Clinical Investigation Approval: 3-6 months additional

Delays commonly occur due to incomplete documentation, CDSCO queries, or pending test reports. At IncorpX, we minimise delays through thorough documentation preparation and proactive CDSCO query management.

ISO 13485 (Quality Management Systems for Medical Devices) certification is mandatory for all medical device manufacturers applying for CDSCO registration. Key requirements:

The certification must be from an accredited certification body
The scope must cover the specific medical device being registered
The certification must be valid at the time of application and throughout the licence period
For imported devices, the foreign manufacturer must hold ISO 13485 certification

IncorpX also provides ISO Certification services to help manufacturers meet this mandatory requirement before filing for CDSCO registration.

Under the Drugs & Cosmetics Act, 1940 and the Medical Devices Rules, 2017, severe penalties apply for non-compliance:

Manufacturing/Importing without licence: Imprisonment up to 3 years and fine up to ₹5 lakhs
Selling unregistered devices: Imprisonment up to 3 years and fine up to ₹1 lakh
Misbranded/Adulterated devices: Imprisonment up to 5 years and fine up to ₹10 lakhs
Spurious devices: Imprisonment up to 10 years and fine up to ₹10 lakhs or three times the value, whichever is more

CDSCO conducts regular surveillance and enforcement drives. All medical devices in India must carry valid registration/licence numbers.

Yes. Software as Medical Device (SaMD) - software intended for medical purposes that functions independently without being part of a hardware medical device - is regulated under the Medical Devices Rules, 2017. CDSCO classifies SaMD based on the risk level of the clinical decision it supports. Examples include diagnostic imaging software, clinical decision support systems, and patient monitoring applications. SaMD requires the same registration process as hardware medical devices - including Device Master File, software lifecycle documentation (IEC 62304 compliance), cybersecurity assessment, and clinical evaluation.

A Free Sale Certificate (FSC) is an official document issued by the regulatory authority of the country of origin confirming that a medical device is approved for sale and use in that country. It is mandatory for all imported medical devices seeking registration in India. The FSC must:

Be issued by the national regulatory authority (e.g., FDA for USA, TGA for Australia, MHRA for UK)
Clearly identify the device by name, model, and intended use
Be authenticated or apostilled as per Indian requirements
Be valid at the time of application submission

For devices approved in countries with recognised regulatory frameworks (US FDA, EU CE, Japan PMDA, Australia TGA), expedited review pathways may be available.

The Medical Devices (Amendment) Rules, 2020 was a significant regulatory update that expanded the scope of medical device regulation in India. Key changes include:

Universal Registration: All medical devices - not just those notified individually - were brought under mandatory registration
Risk-Based Classification: Reinforced the Class A-D risk-based classification system
Timeline for Compliance: Set phased deadlines for existing device manufacturers to obtain registration
Price Control: Certain devices brought under NPPA (National Pharmaceutical Pricing Authority) price caps
Import Monitoring: Strengthened documentation requirements for imported devices

This amendment significantly increased the regulatory compliance burden on medical device companies operating in India.

IncorpX provides comprehensive CDSCO Medical Device Registration services with the following advantages:

Regulatory Expertise: Dedicated team experienced in Drug & Cosmetic licensing and medical device regulations
Complete DMF Preparation: End-to-end Device Master File documentation support
SUGAM Portal Filing: Expert handling of the CDSCO online portal application process
Query Management: Proactive CDSCO query resolution to minimise delays
Clinical Investigation Support: Guidance on clinical investigation design and Ethics Committee approval
Pan-India Coverage: Licence and registration services across all states
Affordable Pricing: All-inclusive package starting at ₹24,999 with no hidden charges

Join hundreds of medical device companies who trust IncorpX for their CDSCO Registration.

Medical Device Registration in various States

Medical Device Registration in Andaman and Nicobar Islands

Medical Device Registration in Andhra Pradesh

Medical Device Registration in Arunachal Pradesh

Medical Device Registration in Assam

Medical Device Registration in Bihar

Medical Device Registration in Chhattisgarh

Medical Device Registration in Dadra Nagar Haveli and Daman Diu

Medical Device Registration in Goa

Medical Device Registration in Gujarat

Medical Device Registration in Haryana

Medical Device Registration in Himachal Pradesh

Medical Device Registration in Jammu and Kashmir

Medical Device Registration in Jharkhand

Medical Device Registration in Karnataka

Medical Device Registration in Kerala

Medical Device Registration in Ladakh

Medical Device Registration in Lakshadweep

Medical Device Registration in Madhya Pradesh

Medical Device Registration in Maharashtra

Medical Device Registration in Manipur

Medical Device Registration in Meghalaya

Medical Device Registration in Mizoram

Medical Device Registration in Nagaland

Medical Device Registration in Odisha

Medical Device Registration in Puducherry

Medical Device Registration in Punjab

Medical Device Registration in Rajasthan

Medical Device Registration in Sikkim

Medical Device Registration in Tamil Nadu

Medical Device Registration in Telangana

Medical Device Registration in Tripura

Medical Device Registration in Uttar Pradesh

Medical Device Registration in Uttarakhand

Medical Device Registration in West Bengal

Medical Device Registration in various Cities

Medical Device Registration in Adilabad

Medical Device Registration in Agra

Medical Device Registration in Ahmedabad

Medical Device Registration in Aizawl

Medical Device Registration in Ajmer

Medical Device Registration in Akola

Medical Device Registration in Aligarh

Medical Device Registration in Allahabad

Medical Device Registration in Amaravati

Medical Device Registration in Ambala

Medical Device Registration in Amravati

Medical Device Registration in Amritsar

Medical Device Registration in Anand

Medical Device Registration in Anantapur

Medical Device Registration in Asansol

Medical Device Registration in Aurangabad

Medical Device Registration in Banaras

Medical Device Registration in Bangalore

Medical Device Registration in Bareilly

Medical Device Registration in Bathinda

Medical Device Registration in Belagavi

Medical Device Registration in Belgaum

Medical Device Registration in Bengaluru

Medical Device Registration in Berhampur

Medical Device Registration in Bhagalpur

Medical Device Registration in Bhavnagar

Medical Device Registration in Bhilai

Medical Device Registration in Bhiwandi

Medical Device Registration in Bhopal

Medical Device Registration in Bhubaneswar

Medical Device Registration in Bikaner

Medical Device Registration in Bilaspur

Medical Device Registration in Bokaro

Medical Device Registration in Calicut

Medical Device Registration in Chandigarh

Medical Device Registration in Chennai

Medical Device Registration in Chittoor

Medical Device Registration in Coimbatore

Medical Device Registration in Cuttack

Medical Device Registration in Davanagere

Medical Device Registration in Dehradun

Medical Device Registration in Delhi

Medical Device Registration in Dhanbad

Medical Device Registration in Dimapur

Medical Device Registration in Dindigul

Medical Device Registration in Dispur

Medical Device Registration in Durgapur

Medical Device Registration in Eluru

Medical Device Registration in Ernakulam

Medical Device Registration in Erode

Medical Device Registration in Faridabad

Medical Device Registration in Firozabad

Medical Device Registration in Gandhinagar

Medical Device Registration in Gangtok

Medical Device Registration in Gaya

Medical Device Registration in Ghaziabad

Medical Device Registration in Gorakhpur

Medical Device Registration in Greater Noida

Medical Device Registration in Guntur

Medical Device Registration in Gurgaon

Medical Device Registration in Gurugram

Medical Device Registration in Guwahati

Medical Device Registration in Gwalior

Medical Device Registration in Hapur

Medical Device Registration in Haridwar

Medical Device Registration in Hosur

Medical Device Registration in Howrah

Medical Device Registration in Hubballi

Medical Device Registration in Hubli

Medical Device Registration in Hyderabad

Medical Device Registration in Imphal

Medical Device Registration in Indore

Medical Device Registration in Itanagar

Medical Device Registration in Jabalpur

Medical Device Registration in Jaipur

Medical Device Registration in Jalandhar

Medical Device Registration in Jammu

Medical Device Registration in Jamnagar

Medical Device Registration in Jamshedpur

Medical Device Registration in Jhansi

Medical Device Registration in Jodhpur

Medical Device Registration in Junagadh

Medical Device Registration in Kadapa

Medical Device Registration in Kakinada

Medical Device Registration in Kanchipuram

Medical Device Registration in Kanpur

Medical Device Registration in Karaikudi

Medical Device Registration in Karimnagar

Medical Device Registration in Karnal

Medical Device Registration in Karur

Medical Device Registration in Khammam

Medical Device Registration in Kharagpur

Medical Device Registration in Kochi

Medical Device Registration in Kolhapur

Medical Device Registration in Kolkata

Medical Device Registration in Kollam

Medical Device Registration in Korba

Medical Device Registration in Kota

Medical Device Registration in Kozhikode

Medical Device Registration in Kumbakonam

Medical Device Registration in Kurnool

Medical Device Registration in Latur

Medical Device Registration in Lucknow

Medical Device Registration in Ludhiana

Medical Device Registration in Madurai

Medical Device Registration in Mahbubnagar

Medical Device Registration in Malegaon

Medical Device Registration in Mangalore

Medical Device Registration in Mathura

Medical Device Registration in Meerut

Medical Device Registration in Moradabad

Medical Device Registration in Mumbai

Medical Device Registration in Muzaffarnagar

Medical Device Registration in Muzaffarpur

Medical Device Registration in Mysore

Medical Device Registration in Mysuru

Medical Device Registration in Nagercoil

Medical Device Registration in Nagpur

Medical Device Registration in Nanded

Medical Device Registration in Nashik

Medical Device Registration in Navi Mumbai

Medical Device Registration in Nellore

Medical Device Registration in Nizamabad

Medical Device Registration in Noida

Medical Device Registration in Ongole

Medical Device Registration in Pali

Medical Device Registration in Panaji

Medical Device Registration in Panipat

Medical Device Registration in Panvel

Medical Device Registration in Patiala

Medical Device Registration in Patna

Medical Device Registration in Pimpri Chinchwad

Medical Device Registration in Pondicherry

Medical Device Registration in Prayagraj

Medical Device Registration in Proddatur

Medical Device Registration in Pune

Medical Device Registration in Raebareli

Medical Device Registration in Raipur

Medical Device Registration in Rajahmundry

Medical Device Registration in Rajkot

Medical Device Registration in Ramagundam

Medical Device Registration in Rampur

Medical Device Registration in Ranchi

Medical Device Registration in Ratlam

Medical Device Registration in Rohtak

Medical Device Registration in Rourkela

Medical Device Registration in Saharanpur

Medical Device Registration in Salem

Medical Device Registration in Sambalpur

Medical Device Registration in Satna

Medical Device Registration in Secunderabad

Medical Device Registration in Shillong

Medical Device Registration in Shimla

Medical Device Registration in Silchar

Medical Device Registration in Siliguri

Medical Device Registration in Solapur

Medical Device Registration in Sonbhadra

Medical Device Registration in Sonipat

Medical Device Registration in Srikakulam

Medical Device Registration in Srinagar

Medical Device Registration in Surat

Medical Device Registration in Tadepalligudem

Medical Device Registration in Tenali

Medical Device Registration in Tezpur

Medical Device Registration in Thane

Medical Device Registration in Thanjavur

Medical Device Registration in Thiruvananthapuram

Medical Device Registration in Thoothukudi

Medical Device Registration in Thrissur

Medical Device Registration in Tiruchirappalli

Medical Device Registration in Tirunelveli

Medical Device Registration in Tirupati

Medical Device Registration in Tiruppur

Medical Device Registration in Tirupur

Medical Device Registration in Tiruvallur

Medical Device Registration in Trivandrum

Medical Device Registration in Udaipur

Medical Device Registration in Ujjain

Medical Device Registration in Vadodara

Medical Device Registration in Vapi

Medical Device Registration in Varanasi

Medical Device Registration in Vellore

Medical Device Registration in Vijayawada

Medical Device Registration in Visakhapatnam

Medical Device Registration in Vizag

Medical Device Registration in Warangal

Guide Incorporation Amendment Rules 2026 Guide

Rated 4.9 out of 5 on Google

Based on 7864+ verified reviews

See all reviews

Code Bonding

5/5

The team was very responsive and helpful. I received daily updates from the WhatsApp group, and their guidance made everything much simpler to comprehend. If you want a simple and hassle-free way to launch your business, I would highly recommend them!

Aug 10, 2025

Simon Job

4.9/5

I recently used IncorpX to register my limited liability partnership, and I had an amazing experience! There were no hidden fees, and the team was helpful, quick to respond, and open. They provided thorough explanations of each step, and their services are reasonably priced without sacrificing quality. The entire process was made simple by IncorpX's professionalism, attention to detail, and sincere support. Strongly advised!

Sep 14, 2025

Jay R

4.8/5

The experience was flawless; the team completed each task with care and always responded quickly. Throughout the process, I never felt stuck. We would especially like to thank Saksham and Sriram for making everything run so smoothly! The IncorpX team offers extremely competitive pricing; anyone just starting out should definitely get in touch with them.

Sep 17, 2025

Mohammed Affan

4.9/5

I'm really grateful to the wonderful team at IncorpX for helping bring my co-founder's and my dream to life. The whole process was super smooth - fast service, great support, and no hassles at all. I'd highly recommend IncorpX to any new entrepreneur or founder looking to register their company. Excited to continue working with them in the long run. Thank you, IncorpX!

Jul 21, 2025

Riyom Taipodia

4.6/5

One of the best agency I have ever experienced. Team members are very friendly as if we know each other from before and came communicate and share easily. My work has been done in a very short period and I am so happy. Thank you so much.

Oct 5, 2025

Ayyappa Swamy

5/5

Highly recommend... IncorpX services regarding incorporation of our company and roc filing and all are very impressive.. the team IncorpX is polite and friendly. Our Lands Time pvt ltd has incorporated through IncorpX... And thanks to IncorpX team..

Oct 25, 2025

Ramesh Babu

4.9/5

Trouble free service, Rendering good co-operation for company incorporation. Trust worthy team to have better knowledge.

Sep 21, 2025

Pravesh Kudesia

5/5

IncorpX is providing best service... And user experience! Thank You IncorpX Team

Oct 30, 2025

Balaji Gutte

4.9/5

I recently got my Private Limited Company incorporated through IncorpX, and the experience was seamless! The team was professional, supportive, and quick to respond throughout the process. Highly recommend IncorpX for a smooth and stress-free company registration experience.

Nov 2, 2025

Dia

5/5

I'd been planning to register my Private Limited Company for months but didn't know where to start - until I found IncorpX. The team guided me step by step, explained everything clearly, and completed the registration smoothly within the promised timeline. Their pricing was transparent with no hidden charges. Highly recommend IncorpX to anyone starting a business!

Oct 7, 2025

Trusted by 15,000+ Entrepreneurs

Get Expert Guidance for Your Business

Fill out the form and our team will connect with you to understand your requirements and recommend the best way forward.

Free Consultation No Obligations Expert Advice

FREE Consultation Get Started @ ~~₹299~~ ₹0

Get Expert Consultation

Talk to our business executives in minutes

Instant Response 100% Confidential Expert Advice

FREE Consultation Get Started @ ~~₹299~~ ₹0

Get Expert Consultation

Talk to our business executives in minutes

Instant Response 100% Confidential Expert Advice

Medical Device Registration in India

Get Your CDSCO Medical Device Registration Under Medical Devices Rules 2017 - Starting @ ₹24,999 Only

Get Expert Consultation

Hear What Our Customers Have to Say

700+

1000+

250+

Why Choose Us?

Expert Legal Team

Fast Turnaround

Dedicated Support

Complete Documentation

Business Growth Tools

24/7 Customer Service

Get Your Medical Device Registered with CDSCO?

Here's How It Works

Fill the Form

Call to discuss

Get Your CDSCO Registration Done

Simple & Transparent Pricing

Medical Device Registration Package

Meet IncorpX Nova

IncorpX Prime

Key Benefits

Important Notes

MEDICAL DEVICE REGISTRATION - AN OVERVIEW

What is Medical Device Registration?

Did You Know?

Classification of Medical Devices (Class A/B/C/D):

Important Note!

Who Needs CDSCO Registration?

CDSCO vs State Drug Controller - Who Regulates What?

Step-by-Step Registration Process for Medical Devices:

Step 1: Device Classification & Regulatory Strategy

Step 2: Prepare Device Master File (DMF)

Step 3: Obtain ISO 13485 Certification & Test Reports

Step 4: Conduct Clinical Investigation (Class C & D)

Step 5: File Application on SUGAM Portal

Step 6: CDSCO Review & Query Resolution

Step 7: Grant of Registration Certificate / Licence

What Are the Documents Required for Medical Device Registration?

Manufacturing Licence vs Import Licence for Medical Devices:

Clinical Investigation Requirements for Medical Devices:

Important Note!

Fees & Timeline for Medical Device Registration:

Why Choose IncorpX for Medical Device Registration?

FAQs on Medical Device Registration

Medical Device Registration in various States

Medical Device Registration in various Cities

Recent Articles & Guides

Companies Incorporation Amendment Rules 2026: Complete Compliance Guide

How to File E-CHNG Form on MCA Portal for Name and Address Changes

How to File INC-20A Commencement of Business Declaration

How to Respond to ROC Notice for Non Compliance in India

How to File STK-2 Company Strike Off Application on MCA V3

How to Convert Dormant Company to Active Status on MCA

NBFC Annual Compliance Checklist Under RBI Guidelines 2026

E-CHNG and E-CON Forms: MCA Replaces 9 Incorporation Forms in 2026

New Company Name Rules 2026: MCA Overhauls Rule 8 and 8A

MCA Incorporation Amendment Rules 2026: 15 Key Changes for Companies

Nirmala Sitharaman's Startup Vision 2026: Key Policy Shifts for New Founders

India Stack for Startups: UPI, Account Aggregator, and DigiLocker Integration

Micro-Finance Company Registration: RBI NBFC-MFI License and Compliance

Private Equity and AIF Registration in India: SEBI Categories Explained

Get Expert Guidance for Your Business

Get Expert Consultation

Get Expert Consultation