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India CDSCO Medical Device Registration and Approval

India is one of the larger medical device markets in Asia, and is still growing at an impressive rate. Increased health awareness, a growing middle class and government health initiatives mean the medical device market is expected to grow about 15% per year for the next several years, albeit from a small base.

Medical device regulations in India

Prior to 2005, no medical device regulations existed in India. However, today there are registration procedures for certain types and classes of medical devices regulated under the provisions of the Drugs and Cosmetics Rules.

In January 2017, India's Ministry of Health and Family Welfare released the Medical Device Rules, 2017, which will take effect on January 1, 2018. This regulation will replace the Drugs and Cosmetics Act upon implementation.

Prior major market approval is required to enter India

Manufacturers interested in registering their medical devices in India must supply evidence of prior regulatory authorization in the US, Canada, Europe, Australia or Japan, as well as proof of approval in their home market. Additionally, each manufacturing facility must be registered. We can help you with this.

Your technical documentation must be submitted for review by the Central Drugs Standard Control Organization (CDSCO), an agency of the Ministry of Health and Family Welfare.

Allow us to 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
  • Coordinate the medical device registration approval with the CDSCO
  • Prepare all necessary documents for the product registration application including Forms 40 and 44 (as required)
  • Coordinate payments of registration fees
  • Represent or accompany you to the Technical Presentation, if required by the CDSCO
  • Provide support with the Subject Expert Committee (SEC) meeting, if required by the CDSCO
  • Coordinate submission of Plant Master File and Device Master File
  • Work with the CDSCO to address follow-up questions and monitor progress
  • Assist with obtaining a Form 10 – Import License for your distributors

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

Ask us for detailed information about India device registration services.

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Frequently Asked 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 MDAC review is not required. A Technical Presentation or MDAC review will extend the timeframe by approximately 3-6 months. Once granted, medical device registrations in India are valid for 3 years.

Which devices require registration in India?

Only certain products require registration in India, and most of these products are outlined in the official List of Notified Medical Devices.

It's important to note that there are some additional products that do not appear on the official list, but do require registration. For example, dental implants and hernia mesh are not identified in the List of Notified Medical Devices. However, the CDSCO’s Medical Device Division page lists them as examples of products that require registration:

If there is doubt regarding whether a device requires registration or not, Emergo can assist in soliciting the CDSCO’s feedback on this matter.