In India, registration must be done through an Independent Authorized Agent or India authorized importer holding either a valid Wholesale Drug License in Form 20B and 21B or Medical Device Registration Certificate in Form MD-42. You have the option to set up your own office if you prefer to register directly. However, partnering with an India Authorized Importer or Independent Authorized Agent, such as Morulaa, allows you to stay abreast and maintain the ever changing compliances in the Indian Healthcare market.

The manufacturer needs to obtain the Import License (Form MD-15) to start selling in India. An Independent Authorized Agent needs to be appointed who can apply on behalf of the manufacturer in India.

In India, a medical device registration license is valid for perpetuity unless its canceled or surrendered. However, it is essential to renew the license every five years by depositing license retention fee to ensure continued compliance with regulatory requirements. A late fee of two per cent will be applicable if the due date is crossed.

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.

Yes, you need to register with the Indian FDA (CDSCO). However, having approval from a GHTF (Global Harmonization Task Force) 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, Complete Technical File with supporting reports as mandated in the Fourth Schedule of the Indian Medical Device Rules (MDR) 2017.

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 whether to grant approval or request local trials. Morulaa has developed a Regulatory Pathway Analysis Tool which will help you determine the pathway and licenses required for India. Please contact us if you wish to learn more about this.

In India, medical devices are grouped into four categories – single, group, family and system. The grouping is determined based on the intended use, device design and manufacturing, material of construction, device risk classification and how it is sold (individual or packaged).

Applications and supporting documents need to be submitted in English for registration on the CDSCO online SUGAM portal.