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:

  • registering your product
  • submitting change notifications
  • transferring product licences
  • ensuring post-market surveillance once your product is authorized and placed in the market, including Mandatory Problem Reporting, Complaint Handling, Field Corrective Actions and Product Recall

Get a quote for in-country representation services in Malaysia

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