What is a Marketing Authorization Holder?
Any company which holds a marketing authorization granted by local authorities responsible for medical devices is called a Marketing Authorization Holder (MAH).
Most countries require foreign manufacturers to have a local Marketing Authorization Holder in the country if they choose not to set up a foreign subsidiary. This Marketing Authorization Holder, also known as the also known as the Local Authorized Representative (LAR) or In-Country Representative will be the regulatory point of contact for the medical device or IVD. The MAH 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.
While the appointment of a local Marketing Authorization Holder does not change the responsibilities of the manufacturer, the MAH must be carefully selected and supervised by the manufacturer. Regulations do not usually include a detailed description of the role and obligations of an MAH 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 Marketing Authorization Holder. 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.
What are the marketing authorization holder responsibilities?
The responsibilities of a marketing authorization holder or local authorized representative are to: