India is one of the largest medical device markets in Asia, and growing at an impressive rate. Increased health awareness, a growing middle class and government health initiatives mean the market is expected to grow about 15% per year for the next several years.
Before manufacturers can legally sell medical devices within India, they must be in compliance with India medical device regulations. Through our full service office in India, we are able to provide a full spectrum of consulting services for obtaining medical device approval in India, and maintaining compliance thereafter.
India's medical device regulations overview
Prior to 2005, no regulations whatsoever existed for medical devices in India. Today there are registration procedures for certain classes medical devices regulated under the provisions of the Drugs and Cosmetics Rules. Comprehensive legislation governing medical devices is pending.
Currently, manufacturers of medical devices which require registration can leverage their approvals in the US, Canada, Europe, Australia or Japan to register their medical devices in India. The full technical documentation used to support those submissions (i.e. 510(k) application, CE Technical File/Design Dossier, Health Canada Medical Device License) must be provided with the device application. This form must be submitted per medical device family.
During the medical device registration process, the primary entity we work with is the Medical Devices Division of the CDSCO. The hierarchy of medical device regulatory entities in India is as follows:
Ministry of Health and Family Welfare
> Drug Controller General of India - DCG(I)
>> Central Drugs Standard Control Organisation (CDSCO - Medical Devices Division)
Professional regulatory support through our local office in India.
Emergo is experienced with all aspects of medical device regulatory compliance in India. Our services include obtaining medical device approval, import licenses, BIS certification and assisting with corresponding clinical trial support if needed. As noted, our consulting team in India works directly with the CDSCO on a daily basis for regulatory submissions. Our team will:
- Determine where (if) your product fits into the list of regulated medical device categories;
- Coordinate the medical device registration approval process with India’s DCG(I)/CDSCO;
- Prepare all necessary documents for the product registration application including Forms 40 and 44;
- Coordinate payments of registration fees;
- Assist with forms necessary to appoint an Indian Agent as your official representative;
- Coordinate submission of Plant Master File and Device Master File as needed;
- Work with the DCG(I)/CDSCO to address follow up questions and monitor progress.
It takes approximately 6-9 months to complete the medical device registration process in India. Once granted, medical device registrations in India are valid for 3 years.