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?
- The in-country representative must have a valid Authorized Representative’s License issued by the Malaysia Medical Device Authority (MDA).
- The representative should also have a Quality Management System certification, namely the Good Distribution Practice for Medical Devices (GDPMD) certification.
Can you appoint multiple marketing authorization holder or representatives in Malaysia?
- No, in Malaysia, foreign manufacturers are not allowed to appoint multiple in-country representatives for the same device.
- The foreign manufacturer must issue a Letter of Authorization on company letterhead, signed and stamped by an officer of the company.
- There is no fixed duration in appointing a marketing authorization holder, however it is possible to transfer the device’s license from one local authorized representative to another.
How Andaman Medical can help with in-country representation in Malaysia:
As your marketing authorization holder or local authorized representative in Malaysia we will:
- represent your company in all dealings with the Medical Device Authority and other institutions responsible for medical devices and in-vitro diagnostics including:
- 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
- Authorising your selected Importers and/or Distributors to import and sell your device in Malaysia
- 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 either English, or together with Malay Bahasa for home use devices
- Accept all calls from the MDA regarding the foreign manufacturer and its products and liaising accordingly with the foreign manufacturer
- Maintain our office including a telephone and email connection in Malaysia
- Monitor regulations to alert you to any changes or new regulations applicable to your product