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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.

medical devices consultant

Additional Responsibilities as per Medical Device Rule 2017 Effective 01st January 2018.

  • Submit all necessary documents, as defined in the Fourth Schedulefor 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

U.S Agent

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.

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