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.
- Expert opinion on best possible market entry pathway
- Evaluate and guide on evolving ground situation of Regulations support for the change of Local Representative and license transfers
- Defending all questions from the agency and perform required Post-Market Obligations, If necessary
- Single point of contact in the country for liaison with Regulatory agency
- Ensuring protection of intellectual property
- Complete control on distribution options.
- Cost-effective solution for Regulatory expertise-based AR support
- Support for region specific Regulatory complexities and challenges
- Extensive partner network across ROW market.