Get Medical Device Registration and Import License in India to Sell and Stay Compliant
Medical Device Registration India Market Regulatory Requirements - CDSCO
Earlier, manufacturers could sell medical devices and in-vitro diagnostics (IVDs) without medical device registration India. Since 2006, medical devices entering India must 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 approval of Medical Devices & IVDs, Drug and Cosmetics in India along with Clinical Trials for Medical Devices and IVDs. 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 a CDSCO license consultant gives you a better understanding of the rules and determines your regulatory pathway for India.
Register Your Medical Device in India
In India Medical device 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 notified requirements, and we handle all India Medical device registration process with precision. Trust Morulaa to ensure compliance with CDSCO guidelines, facilitating smooth regulatory processes like CDSCO medical device registration process India and efficient approval time for your products.
Dossier Submission in Form MD-14 Application by a Medical Device Representative to the CDSCO:
The Medical Device Registration 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, the manufacturer must have a local Indian “authorised agent”. The Indian authorised agent requests for an import licence (via Form MD-14 application) 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. Click here to know more about Form MD-14 Application India
Medical Device Registration India Classifications
Under the Medical Device Registration India (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. Click here to know more about medical device classification in India. A Medical Device Registration India consultant who has the experience in registering similar devices can support you in understanding the risk based classification of your medical devices in India.
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 |
Documents to be Submitted Under Form MD-14 Application India:
The documents required to register medical devices as per the Medical Device Registration India Rules 2017 and Medical Device Rules, 2017with the CDSCO on the SUGAM portal are listed below. These documents are prepared by the overseas manufacturer and your local medical device representative.
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 India form requires each product family to be entered in a separate section. Devices within a product family must share similar characteristics, such as: |
|
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 |
|
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 model number. Also the labels must contain the information of the India Authorized Importer 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. Based on its classification, it will require 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. Click Here to know more about Predicate |
|
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 Rules, 2017. This table provides specific fees applicable to the medical device license for Importing.
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 |
Timelines for India Medical Device Registration as per Medical Device (Amendment) Rules, 2017:
The Medical Device Registration India typically takes 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. Click here to know more about India medical device registration timelines.
Validity of Medical Device Registration:
CDSCO Medical Device Registration India is valid for 5 years, and it is recommended to apply for renewal at least 6 months before expiry. Please note that all CDSCO registration certificates expire alongside the base CDSCO import license. 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. Click here to Know more about Re-registration and renewal process.
Medical Device Import License Transfer Process in India:
As per the Indian Medical Device Rules, 2017. Currently there is no option to transfer a Medical Device Import License 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
The below table gives the possible pathway for medical device approvals in India based on the availability of a Free sale certificate(FSC) from the USA, Japan, European Union, Australia and Canada, and the availability of a substantially equivalent product in India. Any medical device which does not have a substantially equivalent device (in terms of material, intended use and design) is considered an investigational medical device / de-novo 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 |
Post-Approval Changes Including Line Extensions and Addition of New Products to Application:
Post-approval changes refer to the modifications made to medical devices that have already been approved 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.
A Guide to Medical Device Registration in India: Frequently Asked Questions
The MD-14 legal form is the application that the authorised Indian agent needs to fill on their Sugam online portal on behalf of the manufacturer of medical devices. 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 below is the estimated timeline upon submission of documents to the CDSCO
- 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.
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.
Expert Guidance on India Medical Device Regulations: Local Teams Navigating CDSCO Registration Process India and Regulatory Compliance
The continuously evolving requirements of India require a strong partnership with a Medical Device Registration India consultant 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 an experienced Medical Device Registration India consultant, specializing in CDSCO medical device approval processes, Import license in Form MD-15, Post market surveillance, Vigilance, Labeling and other regulatory compliance as applicable with the Medical Device Rules 2017 We provide comprehensive support for the medical device registration process in India, including handling borderline devices and ensuring timely approval time. Morulaa is your trusted partner, an Indian authorized agent for navigating the complex regulatory landscape, ensuring smooth market access and compliance with all medical device registration India processes.