general concept for Marketing Agent Representative

If a manufacturer wishes to market their healthcare product in a foreign market, they will almost always need to appoint a local approved representative or in-country representative if they do not have a registered business location in the target nation.
An authorized representative is any natural or legal person with a local entity in the territory who is specially appointed by the manufacturer, operates on behalf of the manufacturer, and may address authorities and bodies in the country.

Who is eligible to serve as an authorized representative?

Healthcare service distributors or importers might function as the manufacturer’s Authorized Representative (AR) in their respective countries. When a need for several distributors or a change in an existing distributor is found, however, such interaction becomes challenging. It is preferable for manufacturers to choose independent firms with no financial interests as their Authorized Representative, such as PRA. PRA operates as an authorized representative on behalf of overseas manufacturers to help them manage regional requirements for registration, pre-certification, and post-approval queries.

How do we come in?

Through our licensed medical store, we are fully capable to act as your authorized representative in the country. We will represent you legally in the market and through us, you will be able to register, import your products, and conduct initial market tests.

An authorized representative’s typical responsibilities include:

  • In the event of a Field Safety Corrective Action (FSCA), major adverse event reporting to competent authorities, and cooperation with the manufacturer’s distributor, liaison between the healthcare authority and the manufacturer.
  • Assisting regulatory bodies and import/customs officers in a first point contact.
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