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:
- Represent your company in all dealings with the local medical device authorities responsible for medical devices and in-vitro diagnostics including:
- registering your product
- obtaining import licences
- obtaining distribution licences
- submitting change notifications
- transferring product licences
- ensuring post-market surveillance once your product is authorized and placed in the market, including adverse events and product recalls
- Ensure that the appropriate conformity assessment procedure has been carried out, if required
- Ensure that the medical device or IVD is correctly labelled and that information is provided in the specified national language(s)
- Accept all calls from the local medical device authority regarding the foreign manufacturer and its products and liaising accordingly with the foreign manufacturer including scheduling inspection(s) of the manufacturer’s facilities, if required
- Maintain a place of business including a telephone connection and an email address within the country during the term of the agreement
- Assist with complaint handling
- Monitor regulations to alert you to any changes or new regulations applicable to your product.
