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India CDSCO Medical Device Registration and Approval

ANSWERED ON THIS PAGE:

  • What are the medical device registration requirements in India?
  • Do we need home-country approval to sell our device in India?
  • How long does it take to complete India’s device registration process?

India’s medical device market is expected to grow over the next several years due to increased health awareness, a growing middle class, and government health initiatives. Indian authorities overhauled the medical device regulatory process in 2017 with the publication of the Medical Device Rules. The rules came into force in January 2018 and devices are regulated by the Central Drugs Standard Control Organization (CDSCO), an agency of the Ministry of Health and Family Welfare.

With a presence in India, Emergo can help you comply with CDSCO requirements and start selling your device in this emerging market.

Medical device regulatory changes in India

No medical device regulations existed in India prior to 2005. However, today there are registration procedures for certain types of medical devices regulated under the Medical Device Rules. While the list of regulated products is specific, the CDSCO occasionally adds products to the list. Determining if your product is regulated by the CDSCO is the first step marketing entry in India.

India medical device registration requirements

Manufacturers interested in registering their medical devices in India must supply proof of approval in their home market. Providing further evidence of prior regulatory authorization in the US, Canada, Europe, Australia, or Japan can ease some regulatory requirements.

Your technical documentation must be submitted for review by the CDSCO. In addition, you must register all of your device manufacturing facilities.

Emergo can provide regulatory support through our local office in India

If your device requires registration, Emergo is able to provide a full spectrum of consulting services for obtaining medical device approval in India. Our consulting team works directly with the CDSCO on an ongoing basis for regulatory submissions. We will:

  • Determine where (if) your product fits into the list of regulated medical device categories and assess the classification
  • Prepare all necessary documents for the product registration application if requested by your distributor and upload the registration documentation to the CDSCO (this requires the distributor’s online account information)
  • Assist to address CDSCO additional information requests

Please contact us for more information on medical device registration and approval in India.

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Common India device registration questions

What is the timeline for India’s medical device registration process?

It takes approximately 6-9 months to complete the medical device registration process in India, if a Technical Presentation or Subject Expert Committee (SEC) review is not required. A Technical Presentation or SEC review will extend the timeframe by approximately 3-6 months. Once granted, medical device registrations do not expire as long as the Authorised Agent pays the maintenance fee every five years.