The Central Drug Standard Organization (CDSCO), which falls under the jurisdiction of the Ministry of Health of India, regulates the medical device registration in India. In India, medical products are regulated under the Drugs and Cosmetics Act, of 1940 which is a pre-independence legislation. Since then, the Indian government has been reviewing and updating the laws to adapt to the technological advances in healthcare to accommodate medical devices, software, and, in the near future, the impact of artificial intelligence on healthcare.
The Medical Device Rules (MDR), 2017 was further updated as Medical Device (Amendment) Rules, 2020 in India. It was for the first time in 2017 that India formally introduced a Classification System for Medical Devices.
How to register a medical device in India
To register medical devices in India, a manufacturer must be aware of the following:
1. Who to select as the License Holder?
2. How are medical device classified in India?
3. Does the product have a predicate in the market? What is the impact of current global approvals for product registration?
4. What are the documents and costs associated with obtaining approval in India?
5. What are the timelines for approval?
1. Who to select as the license holder?
In India, a local Indian company must be the license holder. Hence manufacturers must make this choice when they are planning their early market strategy for India. Companies who have been in operation in India for several years also have to make this choice as they may have been selling non-regulated medical devices in the past which now need registration under the MDR, 2020 Rules.
This entity could be a local subsidiary, an Independent Agent, or a Distributor. Having an Independent Agent hold the license gives manufacturers the most economical and secure method of maintaining compliance while having commercial freedom when working with their trusted distribution partners in the market.
The license holder must be a registered business entity in India, with a Wholesale Drug License or an MD-42 Medical Device Registration Certificate and a SUGAM account which is the portal to submit files for review to the CDSCO. In addition, they must have an Import Export (IE) Code, GST Number, and all statutory licenses to conduct the Import and trade of medical products in India.
2. How are medical devices classified in India?
Detailed classification guidelines can be found in the MDR guidelines, India. The CDSCO publishes detailed product listings with Generic Names, Intended Use, and Class to help manufacturers determine the suitable Class of their devices in India.
The Indian Classification is similar to the EU MDR classification and can be used as a starting point for manufacturers to understand how they would be classified in India:
On October 14, 2022, as per the G.S.R. 777(E) notification by the CDSCO, Class A non-sterile and nonmeasuring devices come under the self-notified category while the rest of the medical devices come under review by the CDSCO. This means that the Indian Agent can obtain an automatic registration number on the SUGAM portal and use this number to export medical devices to India. All other classes require a review of documents by the CDSCO to obtain the Import License.
3. Does the product have a predicate in the market? What is the impact of current global approvals for product registration?
Having a substantially equivalent predicate and approval from a GHTF Country makes the pathway to approval relatively straightforward in India. Hence it is important for manufacturers to evaluate the below while planning their registration for India as this could increase the timelines and costs associated with getting the Import License:
Substantially Equivalent Predicate: means medical devices that have approval in India and are similar to the medical device being applied for, in terms of material of construction, intended use, and design.
GHTF Country: approval from the following countries – Australia, Canada, Europe, Japan, United Kingdom, United States of America.
If either of these above definitions do not apply to your medical device, then based on the Class and availability of clinical data, the CDSCO could recommend additional review processes/steps via a Special Expert Committee (SEC) or a Medical Device Advisory Committee (MDAC Review). MedEnvoy can assist manufacturers in presenting their clinical data for such reviews.
4. What are the documents and costs associated with obtaining approval in India?
On appointing the Indian Agent and determining the class of the medical devices, an application with supporting documents and fees has to be made on the SUGAM portal for registering the medical device with the CDSCO.
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- This process involves submitting an MD-14 application form that contains the necessary information on your medical device such as Generic Name, Brand Name, Grouping, Intended Use, Material of Construction, Model Numbers, Accessories, etc.
- Documents related to Certification (ISO 13485, Free Sale Certificate, Declaration of Conformity, etc), Manufacturing Site (Plant Master File), and Technical File (Device Master File) have to be submitted to the CDSCO for review. The documents are submitted in English language. During the final step of submission, the CDSCO fees have to be paid to proceed with the submission.A detailed list of documents required for the MD-14 application can be found within this article link. The requirements are similar to those of GHTF countries and can be easily met if your medical device has approval in one of those markets.
- After the dossier is submitted, the CDSCO reviews the files and raises queries as applicable.
- Once the CDSCO is satisfied with the query responses, it issues an MD-15 Import License which can be used to export the medical devices to India.
The table below gives the application fees based on the classification of the medical device by the CDSCO in India:
5. What are the timelines for approval?
The period for Registration of Medical Devices in India is generally 6-9 months, post the submission of a complete and accurate regulatory dossier and fees to obtain the Import License. The clock stops once a query is raised and starts once responded to. New products without any strong predicates in India may take a longer time and/or require an MDAC /SEC review for approval based on the recommendations of the CDSCO.
After obtaining the license, the license typically does not expire; however, license retention fees are due every five years. It is important to keep updating the CDSCO with the post-approval changes that are being done on the medical device as and when they happen.
Learn more about how to register a medical device in India with MedEnvoy
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