Overview

A manufacturer who is willing to market their medical device in a foreign market, may often has to designate a local authorized representative if they do not have a registered place of business in the targeted country. An authorized representative is any natural or legal person having a local entity in the territory who, explicitly designated by the manufacturer, acts and may be addresses the authorities and bodies in the country on behalf of the manufacturer. Pre-requisites and responsibilities of an authorized representative vary depending on the requirements of each region’s Regulatory body. For instance, United States (US) agent for medical devices and In-Vitro Diagnostics (IVD) companies will serve as a liaison between the FDA and foreign establishments which imports or offers for import into the US. The common responsibilities of an authorized representative include:

  • Acting as a first point of contact with Regulatory authorities and import/customs offices 
  • Being responsible for pre-certification and post-approval inquiries
  • Liaising between the medical device authority and foreign manufacturer in incident of Field Safety Corrective Action (FSCA), serious adverse event reporting to competent authorities, and in cooperation with manufacturer’s distributor

To enable foreign manufacturers, navigate the regional Regulatory requirements for registration, pre-certification and post-approval inquiries, Freyr acts as an authorized representative on behalf of the foreign manufacturers. Freyr provides Regulatory assistance to help the applicants/foreign manufacturers to communicate with local agencies regarding deviations, queries and any other Regulatory interactions.

Freyr Expertise

  • Single point of contact in the country for liaison with Health Authorities (HAs)
  • Independent marketing authorization holder (MAH) services
  • Support for the change of legal representative
  • Continuous liaison with agency for submissions, queries and feedback
  • Agency interaction in regional languages for APAC, LATAM, and Europe markets

Freyr Advantages

  • Cost-effective
  • Flexibility to change the distributors
  • Strong relationship with different HAs
  • Qualified team of experts with hands-on experience across all categories of medical devices
  • Support for region specific Regulatory complexities
  • Extensive partner network across the globe
  • Structured approach to ensure quick market access