REGISTAR* - MEDICAL DEVICE REGISTRATION

Registar* is the programme from Quality First International that registers medical devices with any country in the world. QFI identifies and applies specific pre- and post-market medical device registration requirements and prepares summaries or detailed medical device registration submissions. Registar* offers individual low-cost reports that offer guidance through each country’s medical device registration requirements. Alternatively, Registar* completely manages the entire registration process of a medical device to any country.

Medical device registration is a significant issue when marketing in Europe. The Directives transposed into national laws, whereby each EU  Member State has written the mandatory use of its own language for the information on the product and/or labelling for example,  according to paragraph 13 of Annex I to Council Directive 93/42/EEC, means that some EU Member States operate distinct registration scheme of medical devices in order to control medical devices on the market.

Service Level 1: Country Registration Overview

For each country of interest this service provides:

  • a Country Registration Summary Report
  • a comprehensive review of country medical device registration regulations
  • the language requirements for all documentation required for medical device registration
  • application forms and other associated documentation

Service Level 2:  Full Registration Management

For each medical device undergoing registration, this service provides:

  • a device registration device Action Plan
  • a detailed Registration Report for the registration of the device in the desired country
  • full submission of all application forms and corresponding documentation
  • complete management of the registration of the medical device
  • translation services

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