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?
- 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 holders 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.
What Andaman Medical will do as your local authorized representative in Malaysia:
As your 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
- Authorize 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