Local Authorized Representative Support – ROW

Overview

Markets other than the European Union (EU) and the USA are referred as Rest of world (ROW). Medical Device manufacturer who intends to enter a foreign market must assign a local Authorized Representative (AR) or in-country representative, if they do not have offices in that market. A local authorised Medical Device representative acts as a point of contact between the manufacturer and the national competent authority or Regulatory agency responsible for regulating the device import and sale in the country. It’s a critical decision to choose an in-country representative/medical device representative, who has an expertise in Regulatory requirements for target product, to provide best support for device manufacturers.

Local Authorized Medical Device Representative (i.e. In-country Representative) carry out the below major activities:

• Assist the manufacturer in filing Medical Device registrations, as per the local Medical Device authority requirements
• Assist the manufacturer in all Regulatory communications with the Medical Device authority in pre & post approval phases of product lifecycle
• Ensure that the submission and approval procedure has been carried out as per country specific requirement, that the Medical Device is correctly labeled and that document is provided in the specified local language
• Respond to questions, either by direct response or by a commitment to the authority, to provide a timely response following consultation with the manufacturer, regarding products in scope.