Drug- Authorized Agent/ Registration Holder Support

Drug- Authorized Agent/ Registration Holder Support

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India. The CDSCO is governed by The Drugs and Cosmetics Act, 1940 and Rules, 1945. In India, manufacturing, import, sale and distribution of Medical devices is regulated under Drugs and Cosmetics Act and Rules. Some of the medical devices that require registration in India include dental implants, cochlear implants, spinal needles, tracheostomy tubes, annuloplasty rings, syringes and needle, heart valves, cardiac stents, orthopaedic implants, endotracheal tubes, catheters, etc.

For any company who wishes to legally register, market, import and sell medical device in India, the company has to comply with the regulations by the CDSCO. The company who does not have local presence and/or does not have a registered office in India, has to hire an authorised Indian agent to manage registration and post-market surveillance requirements. The authorised agent liaises between overseas manufacturer and the government.

An “Authorised Agent” means an entity or person in India authorised by the manufacturer. The authorised agent is responsible for the business activities of the manufacturer in India including compliance to the Act laid by the regulatory authority in all respects.

The appointed Authorised Representative is also responsible for post-market surveillance and pre-certification. Only one Indian Authorised Representative office is needed for the whole country.

CliniExperts will provide you with end to end solution from dossier preparation, submission, follow-up with the CDSCO, labelling requirements, and obtaining the relevant certification for your medical device. CliniExperts can be your ideal Authorized Agent in India and can represent you legally in India without any commercial conflict of interest activities like product marketing, product distribution, product sales etc.