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.
Additional Responsibilities as per Medical Device Rule 2017 Effective 01st January 2018.
Submit all necessary documents, as defined in the Fourth Schedule, for the import license of the medical device.
Comply with all the conditions imposed on the import license and with provisions of the Medical Devices Rules, 2017.
In case of any violation of Drugs and Cosmetics Act, 1940 (23 of 1940) and the Medical Devices Rules, 2017, the authorized agent shall continue to be responsible even after withdrawing of this Power of Attorney for the devices imported in India
Foreign Medical Device facility must appoint U.S. agent to register and sell their Medical Devices in U.S.A.U.S. Agent responsibilities:
Keep a physical office in the USA
U.S. Agent Program for Medical Device Manufacturers
Provide updates of the establishment registration and product listing
Be responsible to provide communications between the FDA and the Company, ie. upcoming inspections of the foreign site
Foreign facility responsibilities:
Provide their Agent an update of changes to the Establishment registration (e.g. address, change in ownership)
Notify their Agent of any new products or changes to already listed products (e.g. dropping them from the product line)
Notify their Agent of changes in telephone numbers, fax numbers or email addresses.
Alpine Quality Consultants a Technical Consultancy Service Company for Healthcare Industry founded in 2013 by the Group of Visionary Professionals. The company has grown organically into the technical consultancy in the healthcare industry. In today's cost competitive and increasingly stringent regulatory environment, many companies are choosing to outsource solutions. In many smaller companies, QMS tasks are often added to the responsibilities of personnel who do not have the time, knowledge or experience to handle them. As a result, regulatory compliance and ongoing quality management system/improvement often do not receive the attention it requires.