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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.
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