A manufacturer who is willing to market their Medical Device in a foreign market, may often has to designate a local authorized representative or in-country representative, if they do not have a registered place of business in the targeted country.
A Medical Device authorized representative is any natural or legal person having a local entity in the territory, who is 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 a Medical Device authorized representative vary between various Health Agencies. For instance, United States (U.S.) agent for Medical Devices and In-Vitro Diagnostics (IVD) will serve as a liaison between the FDA and foreign establishments which imports or offers for import into the U.S. 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
Who Can Act As An Authorized Representative?
The distributors or importers of the devices can act as an Authorized Representative (AR) of the manufacturer in the respective countries. However, such engagement poses difficulty when a need to have multiple distributors or change in existing distributor is identified.
The distributor or importer, who holds the device license, may be reluctant to authorize another distributor to market the device. Manufacturers usually end up re-registering the device again as distributors also do not issue No Objection Certificates (NoC) for transfer of device license. Considering all these scenarios, it is ideal for the manufacturers to appoint independent entities, with no commercial interests such as, Freyr as their Authorized Representative.
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.
- 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 the Europe markets
- 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