Local authorized 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 Authorized Representative (LAR). The LAR is also called an in-country representative or marketing authorization holder.

Andaman Medical has been a Local Authorized Representative in Malaysia since 2014.

Medical device manufacturers and distributors appoint Andaman Medical to represent them in Malaysia regarding all matters raised by the MDA; the legal authority for medical devices in Malaysia. As your authorized representative we will have the authority to act on your behalf concerning your obligations under the Malaysian medical device regulatory system.

What are the requirements for a local authorized representative in Malaysia?

Can you appoint multiple marketing authorization holders or representatives in Malaysia?

What Andaman Medical will do as your local authorized representative in Malaysia:

As your 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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