Local authorised representative in Malaysia
The Medical Device Authority (MDA) in Malaysia requires foreign manufacturers who have not set up their own legal subsidiary to appoint a Local Authorised Representative (LAR), sometimes referred to as the in-country representative or marketing authorization holder.
The LAR means any person explicitly designated by a manufacturer, to represent them within Malaysia, in respect of matters raised by the MDA, with regard to the manufacturer’s obligations under the Malaysian medical device regulatory system. The LAR must be a legal person incorporated in Malaysia or natural or legal person with business registration in Malaysia.
Andaman Medical has been a LAR in Malaysia since 2014.
What are the requirements for a marketing authorization holder or LAR in Malaysia?
Can you appoint multiple marketing authorization holder or representatives in Malaysia?
How Andaman Medical can help with in-country representation in Malaysia:
As your marketing authorization holder or local authorized representative in Malaysia we will: