Local authorised representative
Most countries require foreign manufacturers to have a local authorised representative (LAR) in the country if they choose not to set up a foreign subsidiary. This representative, also known as the in-country representative, local agent, or marketing authorization holder will be the regulatory point of contact for the medical device or IVD. The LAR represents the foreign manufacturer in all dealings with the local medical device authorities such as for product registrations, import licences, distribution licences, change notifications, post-market surveillance including adverse events and product recalls.
What are the marketing authorization holder responsibilities?
While the appointment of a local authorized representative does not change the responsibilities of the manufacturer, the LAR must be carefully selected and supervised by the manufacturer. Regulations do not usually include a detailed description of the role and obligations of an LAR so it is of vital importance to both the foreign manufacturer and the in-country representative, to set up a contract specifying the tasks and authority the foreign manufacturer will delegate to the local authorized representative. It is also vital to choose an in-country representative who fully understands the regulatory requirements for that country so they can act in the best interests of the foreign manufacturer.