Registration of medical devices in India is regulated by the Central Drug Standard Control Organization (CDSCO) under the Medical Device Rules, 2017, and the Drugs and Cosmetics Act of 1945.
For more information about MedEnvoy’s India Agent Importer service, click here.
Frequently Asked Questions When Undergoing Medical Device Registration in India by CDSCO
This article comes with some frequently asked questions for registering your device in India:
1. Can I Register Directly?
Registration in India must be via a local authorized representative/importer having the necessary licenses to deal with medical products. You can set up your own office if you wish to register directly. However, working via an Independent Importer / Independent Authorized Agent like Medenvoy will allow you to enjoy the independence of direct business at a minimal cost.
2. Does My Application Need to be in the Local Language? How Much Will It Cost Me to Register my Products in India?
The application and supporting documents must be in English when applying for registration. The CDSCO fees are based on the product classification. You must pay the fees per Legal Manufacturing Site and Per Product Family.
Below is a table for the same exclusive of any local taxes:
3. Can Registration for Medical Devices in India by CDSCO be Faster if Your Medical Device is a Low-Risk Device?
The frame is still the same unless it is Class A non-sterile non-measuring device. Class A non-sterile, non-measuring devices have the possibility for an automatic route to approval via self-declaration.
4. How Long Does the Medical Device Registration in India Take to Get Approval?
Typically, it takes 6-9 months to submit all required documents. The clock stops when a query is raised and restarts on submission of the query.
5. I have a Registration Certificate From the USA / EU / UK – Do I Still Need to Register to CDSCO in India? What are the Documents Required?
Yes, you need to register with the CDSCO. However, having approval from a Global Harmonisation Task Force (GHTF) country supports your application. The documentation is similar to what you would submit for an EU MDR application such as an ISO Certificate, CE Design, Free Sale Certificate, Quality Manual, Technical File on the device, etc.
6. What is the Classification of my Product in India?
On its website, the CDSCO publishes the product name, intended use, and possible classification to support you in deciding the classification (A, B, C, D) of your device in India. On a generic basis -> Class I ~Class A, Class IIa ~Class B, Class IIb ~Class C, Class III ~ Class D. However, this must be checked against the published guidelines and upon review of your files the CDSCO may ask for a different classification.
7. How Long Does the License Remain Valid?
The license remains valid for 5 years and then requires re-registration. By working with MedEnvoy, the India CDSCO registration ensuring that the re-registration process is simple and straightforward.
8. Do I Need to do Local Clinical Trials in India?
If your product has approval from a GHTF Country and a strong predicate (equivalent product) device 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, and market data in front of a panel of experts who will determine whether to grant approval or request local trials.
9. Once the Registration Certificate is Obtained can we Sell it Directly to our Distributor?
The Registration Certificate Holder is also the Importer. The goods can be sent on a Bill-to-Ship to model with the Ship to address being that of your distributor. Medenvoy provides a seamless experience to help you maintain a smooth supply chain for your medical devices in India as your Independent Importer / Independent Authorized Agent.
Learn More About the Medical Device Registration Process in India by CDSCO with MedEnvoy
MedEnvoy’s regulatory experts can assist manufacturers in staying compliant with the latest requirements in the registration process in India by CDSCO. Please reach out should you need assistance by clicking here and for information about our regulatory experts click here.
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