Registration of medical devices in India is regulated by the Central Drug Standard Organisation (CDSCO) under the Medical Device Rules, 2017 and the Drugs and Cosmetics Act of 1945. This article comes some frequently asked questions for registering your device in India.

1. Can I register directly?

In India, registration must be done through a local authorized representative or importer with the necessary licenses to handle medical products. You have the option to set up your own office if you prefer to register directly. However, partnering with an Independent Importer or Authorized Agent, such as Morulaa, allows you to maintain the independence of direct business at a minimal cost.

2.Does my application need to be in a local language? How much will it cost to register my products in India?

Applications and supporting documents need to be submitted in English for registration on the SUGAM portal. CDSCO fees are based on product classification. Fees must be paid per legal manufacturing site and per product family. Below is a table of the fees, exclusive of any local taxes.

3.Our device is low risk – can we get approval faster?

The time frame remains the same unless it is a Class A non-sterile, non-measuring device. Class A non-sterile, non-measuring devices may have an automatic approval route through self-declaration on the MD-14 form.

4.How long does it take to get approval?

It typically takes 6-9 months after submitting all required documents on the SUGAM portal. The clock pauses if a query is raised and resumes once the query is addressed.

5. I have a registration certificate from the USA / EU / UK – Do I still need to register in india? What are the documents required?

Yes, you need to register with the Indian FDA (CDSCO). However, having approval from a GHTF country supports your application. The documentation is similar to what you would submit for an EU MDR application or US-FDA such as ISO Certificate, CE Design, Free Sale Certificate, Quality Manual, Technical File on the device etc.

6.How is my product classified in India?

The CDSCO website provides Product Name, Intended Use, and Possible Classification to help determine the local classification (A, B, C, D). Generally, Class I corresponds to Class A, Class IIa to Class B, Class IIb to Class C, and Class III to Class D. However, this should be verified against the published guidelines, and the CDSCO may request a different classification upon reviewing your files.

7. How long does the license remain valid?

The license is valid for prepetuity and has to be renewed every 5 years. Working with Morulaa is beneficial in such a situation as we can help you maintain your license with all changes being timely intimated to the CDSCO and make the re-registration simpler.

8.Do I need to conduct local clinical trials in India?

If your product has approval from a GHTF Country and a strong predicate (equivalent product) actively selling in India, typically clinical trials are not required. However, if either of these two conditions are not met, you get an opportunity to present your clinical studies, market data in front of a panel of experts who will determine to grant approval or request local trials.

9.Once the registration certificate is obtained, can we sell directly to our distributor?

Yes, the Registration Certificate Holder also serves as the Importer. Goods can be sent using a Bill-to-Ship model, with the shipping address being that of your distributor. Morulaa offers a seamless experience to help maintain a smooth supply chain for your medical devices in India as your Independent Importer or Independent Authorized Agent.

10. Which accessories need to be listed?

Only those accessories or components defined in the Device Master File as part of the main device(s) and mentioned in its Instructions for Use (IFU) need to be listed.