What are the requirements for a local authorized representative in Malaysia?
The in-country representative is required to hold a valid Authorized Representative’s License issued by the Malaysia Medical Device Authority (MDA).
The representative are also required to 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?
Foreign manufacturers are allowed to appoint multiple in-country representatives
Foreign manufacturer are required to issue a letter of Authorization on company letter head, signed and stamped by an officer of the company.
Device license can be transferred from one local authorised representative to another.
Our local authorised representative service includes:
Act as the official representative for your company and handles all interactions with the Medical Device Authority and other relevant institutions reponsible for medical devices and in-vitro diagnostics, which includes:
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
Renewal of product registration
Authorise your appointed importers or distributors to import and market your device in Malaysia
Ensuring required procedure such as conformity assessment is done accordingly
Ensuring that the labelling of the medical device is done correctly
Handling all enquiries from MDA regarding manufacturers and products information
Feel free to contact us with questions or comments!
