CDSCO India Medical Device Registration Process: Step by Step Import License Approval Process
How to Obtain a CDSCO Import License (Form MD-14/MD-15)
Earlier, manufacturers could sell medical devices and in-vitro diagnostics (IVDs) without medical device registration India. Since 2006, manufacturers entering India must obtain the medical device import license to be in compliance with the below laws and regulations by the Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare (MoHFW).
The CDSCO is responsible for the India medical device regulations. The body lays down and regulates standards for medical devices & IVDs, control over the quality of imported medical devices & IVDs, coordination of the activities of State Organizations and providing expert advice with a view of bringing about the uniformity in the enforcement of the Medical Device Rules, 2017 India and Drugs and Cosmetics Rules and Act, 2017. Working with Morulaa gives you a better understanding of the rules and determines your regulatory pathway for India.
India Medical Device Registration
Medical device India regulations is managed by the Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health. These devices are regulated by the Drugs and Cosmetics Act of 1940. Our expertise with CDSCO import license form MD14 and adherence to the Medical Device Rules India 2017 to ensure that your products meet regulatory standards. We provide a wide range of regulatory services in India, assisting you through the regulatory landscape.
Our Regulatory services include everything from registration to market access for your devices in India. We are well-versed in obtaining the medical device import license for notified requirements. Trust Morulaa for compliance with CDSCO guidelines, facilitating smooth regulatory processes with efficient approval timelines for your products.
Dossier Submission in Form MD-14 Application for Medical Devices in India:
The Medical Device Approval Process in India (Amendment) Rules, 2017 were published under G.S.R. 78(E) which was further updated as Medical Devices (Amendment) Rules, 2020. In order for an overseas manufacturer to register their medical devices in India and get the medical device import license, the manufacturer must have a local Indian “authorised agent”. The Indian authorised agent requests for an import licence for the medical device from the Central Licensing Authority (CDSCO) and submits the Form MD-14 application through the identified online portal (SUGAM). After the examination of the documents by CDSCO, the CDSCO issues an import licence in Form MD-15. This Form MD-15 is the legal document which allows overseas manufacturers to import their medical devices into India.
India Medical Device Registration: Classification (Classes A–D under MDR 2017)
Under the CDSCO medical devie import license (Amendment) Rules, 2017, medical devices and in-vitro diagnostics (IVDs) are classified into four groups based on risk, as specified in the official Gazette:
- Class A: Low risk
- Class B: Low moderate risk
- Class C: Moderate high risk
- Class D: High risk
Devices which are non-invasive, non-sterile and non-measuring and low risk come under Class A non-notified category.
|
EU-MDR CLASSIFICATION
|
INDIAN CLASSIFICATION
|
|---|---|
|
Class I Self-Certified under EU MDR |
Class A Self-Notified (non-sterile, non-measuring) |
|
Class I Notified EU MDR |
Class A Notified |
|
Class IIa EU MDR |
Class B |
|
Class IIb EU MDR |
Class C |
|
Class III EU MDR |
Class D |
Step-by-Step CDSCO Medical Device Registration Process (India)
Step 1 – How to Identify If Your Medical Device Needs Registration in India.
Step 2 – Appointing an Authorized Indian Representative for CDSCO Compliance.
Step 3 – Submit the Regulatory Dossier under Form MD-14/MD-15
Step 4 – Obtain Registration Certificate in Form MD-15
Step 5 – How to Secure an Import License for Medical Devices in India
Step 6 – Guidelines for Marketing Medical Devices in India After Registration
Documents Required for Medical Device Registration (India – Form MD-14)
The documents required for India medical device registration process as per the Medical Device Registration Rules 2017 with the CDSCO on the SUGAM portal are listed below. These documents are prepared by the overseas manufacturer and Morulaa. CDSCO guidelines for medical devices is published on their website.
|
Documents
|
Class A Self Notified
|
Class A Notified
|
Class B, C, D Devices
|
Tips
|
|---|---|---|---|---|
|
Form MD-14 Application |
YES |
YES |
YES |
The Form MD-14 application requires each product family to be entered in a separate section. For more guidance on grouping product families for CDSCO medical devices registration in India,click here to know more about Form MD-14 Application India. |
|
Free Sale Certificate(FSC) from Country of Origin |
YES |
YES |
YES |
Free Sale Certificate (FSC): Should specify the model name and model number to match the CDSCO MD14 form and POA when applying for the cdsco registration for medical devices |
|
Other Certificates (Power of Attorney, Free Sale Certificate(FSC) from GHTF Country, ISO 13485, CE / EC Design Certificates) |
NO |
YES |
YES |
Power of Attorney: Ensure all details align between the MD-14 application checklist and the Power of Attorney, particularly the product details. Additionally the POA is in the name of Morulaa or your India Authorized Importer |
|
Home country approval or approval from a Global Harmonization Task Force(GHTF) Countries(Europe, USA, Canada, Japan, Australia, or the UK) |
YES |
YES |
YES |
If your medical devices are already registered in a GHTF country (Europe, USA, Canada, Japan, Australia, or the UK), your approval process in India can potentially be expedited. Having approval from a GHTF (Global Harmonization Task Force) country supports your application. |
|
Company Document Checklist (DOC, Audit Report, Plant Registration Certificate, Quality Manual, Device Technical File, Essential Principles Checklist, Post Marketing Surveillance data) |
NO |
YES |
YES |
Labels of the Medical Device: must include the model name and number, as well as the details of the India Authorized Importer, in accordance with the CDSCO labeling requirements for medical devices Instructions for Use (IFU): Must cover details such as intended use, model name, model number, and accessories as submitted in the documentation for the regulatory process in India. They can be prepared similar to the IFU requirements under EU-MDR |
|
Predicate - Substantial Equivalence comparison |
NO |
NO |
YES |
A predicate device is considered to be substantially equivalent if it is identical in terms of material, intended use, and design. In cases where a predicate is not available, the product is referred to as an investigational medical device or a De Novo device. On meeting the CDSCO for medical devices SEC, it will be determined either clinical trials or clinical data from the country of origin. Certifications from the US, Europe, UK, Australia, Canada, or Japan can be used as proof to demonstrate that the device is safe for the Indian population and for the special expert committee to consider waiving the requirement for a local clinical trial. |
|
Additional Data (BRC / COA, Device Design, Verification, Risk, Biocompatibility, Stability, Software etc.) |
NO |
NO |
YES |
Shelf Life Data: Include results from real-time and accelerated ageing tests that support the shelf life mentioned in the Form MD-14 application. The shelf life documents must match the data uploaded in the SUGAM online checklist for the MD-14 application |
|
Scientific Data (Preclinical Animal Studies, Clinical Studies and Published Papers) |
NO |
NO |
YES |
Data which shows safety on patients who are of Indian ethnicity strongly supports the application |
CDSCO Fees for Medical Device Registration in India:
These CDSCO fees, which apply to each medical device Import License for manufacturing sites and each product, range from $0 for Class A devices to $4,500 for Class D devices, as specified in the Medical Device Regulations, 2017. This table provides specific fees applicable to the medical device license for Importing.
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Device Class
|
Manufacturing Site Fees (Per Legal Site)
|
Device Family Fees (Per Device Family)
|
|---|---|---|
|
Class A Self-Notified
|
US $0.00 |
US $0.00 |
|
Class A Notified
|
US $1000.00 |
US $50.00 |
|
Class B |
US $2000.00 |
US $1000.00 |
|
Class C |
US $3000.00 |
US $1500.00 |
|
Class D |
US $3000.00 |
US $1500.00 |
CDSCO Registration Timelines & Import License Approval Duration:
The CDSCO Import License Registration Approval Process India typically takes a timeline to approval of 6-9 months after submitting a complete and accurate regulatory dossier along with the required fees to obtain the CDSCO Import License. The review period pauses when a query is raised and resumes once it is addressed. New products without strong predicates in India may take longer and might require an MDAC or SEC (Special Expert Committee) review for approval based on CDSCO recommendations.
Post-Approval: Validity & Renewals
CDSCO Medical Device Registration License in India is valid for 5 years, and it is recommended to apply for CDSCO renewal at least 6 months before expiry. Please note that all CDSCO registration certificates expire alongside the base CDSCO import license as per medical device regulations in India. If multiple products are registered over the five years through endorsements or line extensions, they will all expire at the same time. For example, if a base medical device import license was issued in 2020 and additional products were added in 2024, the entire CDSCO registration, including the 2024 additions, will expire in 2025 after five years and will need renewal.
Medical Device Import License Transfer Process in India:
Currently there is no option to transfer the India medical device registration from one medical device representative to another. Hence, a fresh Import license is required for adding or changing the India Authorized representative.
Impact of Approvals From & Impact of Substantially Equivalent / Predicate Device
| Class | Approval from USA, Japan, European Union, Australia, and Canada | Availability of Substantial Equivalent in India | Possible Pathway | Forms | Estimated Timeline |
|---|---|---|---|---|---|
| Class A / B | Yes | Yes | Document Review Fast Track Process | MD-14 | 6 – 9 MONTHS |
| Yes | No | Clinical trials from the country of origin may be considered to waive local trials in India | MD-14, MD-26 | 9 – 12+ MONTHS | |
| No | Yes | Clinical trials from the country of origin may be considered to waive local trials in India | MD-14, MD-26 | 9 – 12+ MONTHS | |
| No | No | Have to undergo clinical trials in India | MD-14, MD-26, MD-16 | 18+ MONTHS | |
| Class C / D | Yes | Yes | Document Review Fast Track Process | MD-14 | 6 – 9 MONTHS |
| Yes | No | Clinical trials from the country of origin may be considered to waive local trials in India | MD-14, MD-26 | 9 – 12+ MONTHS | |
| No | Yes | Clinical Investigation Must be carried out in India | MD-14, MD-26, MD-16 | 18+ MONTHS | |
| No | No | Have to undergo clinical trials in India | MD-14, MD-26, MD-16 | 18+ MONTHS |
CDSCO Medical Device Import License Validity, Renewal & Post-Approval Changes
Post-approval changes refer to the modifications made to medical devices that have already been approved and granted the medical device import license by the Central Drugs Standard Control Organisation (CDSCO). The CDSCO classifies these changes as per the Medical Device Rules, 2017 and the Drugs and Cosmetics Act, 1960 into the following two types:
Major changes – Substantial potential impact.
Minor changes – Minimal potential impact.
The MD-14 legal form is the application that the authorised Indian agent needs to fill on their Sugam online portal as required by the medical device regulatory affairs of India. This form is a critical certificate as it leads to the MD-15 CDSCO import license. All data in this form, such as the model number, model name, and shelf life, must match to avoid issues in obtaining the No Objection Certificate (NOC) from the ADC at customs. A medical device consultancy like Morulaa can help you create a legal form which forms the most important document for submission in India.
When registering a medical device in India, it's essential to check if the device has received approvals from GHTF countries like the EU, UK, U.S., Japan, Canada, or Australia, as well as Home Country approval. It's also important to understand the device's classification according to EU MDR. Furthermore, you should assess the number of (contract) manufacturers and manufacturing sites involved, along with the availability of a Declaration of Conformity (DoC) to identify the correct grouping for registration in India.
Based on the availability of a predicate, the estimated timeline as per medical device regulatory requirements India are
- If predicate and GHTF country approval is available: 6-9 months
- If there is no predicate and a review is needed: 9-12 months
- If clinical investigations in India are needed: 18+ months
Your CDSCO License Consultant will be able to guide you to determine the pathway and timelines for India
Class IIa, IIb and III devices with a predicate on the Indian market and GHTF country approval do not require local trials.
- Check if the device falls into Class A, B, C, or D as per CDSCO classification.
- Class A and B devices follow a less stringent pathway compared to Class C and D.
Class A Self Certified Non-Sterile and Non-Measuring Devices without GHTF country approval usually do not require clinical testing, if there is a predicate on the Indian market and adequate clinical data from the home country.
As per the medical device regulatory compliance in India, all other classes – Class IIa, IIb, III without a predicate and/or GHTF approval require a special review from the SEC (Special Expert Committee). Based on the outcome of this meeting, the SEC Committee will determine what type of trials are needed in India.
No, the DMF is not required for Class A Self Certified submissions. However, it is mandatory to create a DMF for devices falling under higher risk categories.
No, a soft copy of the DMF is sufficient for the submission in India. However the DMF needs to be in the manufacturer's company letterhead and it has to be signed by the authorized regulatory person in their company.
The list of cdsco approved medical devices can be found as a database on the SUGAM portal where the latest devices are published regularly.
Expert Guidance on India Medical Device Registration: Local Teams Navigating CDSCO Registration Process and Regulatory Compliance
The continuously evolving cdsco regulatory requirements of India require a strong partnership with an authorized agent offering regulatory services, no matter how you decide to do business—either direct or via a subsidiary. We are here to be a part of your journey in our beautiful land of opportunities.
Morulaa is one of the largest Indian companies with experience in Indian medical device regulations, specializing in CDSCO approvals, import licenses, PMS, vigilance, and labeling compliance. We provide comprehensive support for the medical device registration process in India, including handling borderline devices and ensuring timely approval time.
Further Reading
• CDSCO MDR Process – 18 Top Questions Answered: Explains key steps and common procedural questions under India’s MDR 2017.
• CDSCO Import License FAQ – Common queries about the CDSCO import license and registration documentation process
• Medical Device Labeling in India (CDSCO) Detailed guidance on CDSCO labeling requirements.
• CDSCO Authorized Agent for Medical Device Overview of Indian authorized agent responsibilities and documentation