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 types of 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 supply evidence of prior marketing authorization in the US, Canada, Europe, Australia or Japan, plus proof of approval in their home market, in order to register their medical devices in India. Full technical documentation must be submitted for review by the CDSCO. Additionally, each manufacturing facility must be registered.
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 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 (as required);
- Coordinate payments of registration fees;
- Accompany you to technical meeting(s) with the CDSCO, if required for your application;
- Provide support with a Medical Device Advisory Committe (MDAC) review, if required by the CDSCO;
- Assist with forms necessary to appoint an India Authorized 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;
- Request a Form 10 - Import License for each of your distributors.
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.