We at AQC Provide Authorized Representative services for Medical Device Companies.
European Authorized Representative (EC REP)
If you are Medical Device Company and interested in selling your products in Europe, you are required to European Authorized Representative to represent your company to the Regulatory Authorities. Foreign manufacturers (Non- EU Medical Devices Companies) who want distribute their medical device in Europe must appoint a European Authorized Representative (EC REP).
The role of European Authorized Representative (EC REP):- Communicate between the manufacturer and the Competent Authorities.
- Assist in Medical Device Registration.
- Answer all questions arise from Competent Authorities (MOH) or from users.
Indian Authorized Agent / Representative
Foreign Medical Device Companies must appoint an agent to register and sell their Medical Devices in India. Indian Authorized Representative is a person/ company inquiry that granted Authorization by the Foreign Medical Device Company for pre-certification and post-market surveillance.
Roles of Indian Authorized Agent- Act as the official representative for obtaining import license in India.
- Legally liable for the product in India.
- Liaison between the manufacturer and the CDSCO (Central Drugs Standard Control Organization).
- Respond all queries arise from CDSCO or from users.
- Post market surveillance and complaint handling.
- Involved in vigilance activities and acts on the manufacturer’s behalf if an on-site inspection of the manufacturer’s facility is required.