Malaysia

How to register a medical device in Malaysia?

Registering a medical device in Malaysia involves a process governed by the Medical Device Authority (MDA), which operates under the Ministry of Health Malaysia. Here's a general guide on how to register a medical device in Malaysia:

Determination of Device Classification

Identify the classification of your medical device based on risk (Class A, B, C or D). The classification will determine the regulatory requirements.

Appointment of a Local Authorized Representative

Non-Malaysian manufacturers are required to appoint a local authorized representative who is a Malaysian citizen or has a permanent residence in Malaysia.

Pre-submission Meeting (Optional)

It is advisable to arrange a pre-submission meeting with the MDA to discuss the registration process and requirements.

Preparation of required documents

Collect and prepare the necessary documentation, which typically includes, device description and specifications, manufacturing information, quality management system documentation, clinical data (if applicable), labeling and packaging details and declaration of conformity.

Submission of Application

Prepare and submit the application form along with the required documentation to the MDA. Submission can be done electronically through the Medical Device Centralized Online Application System (MeDC@St).

Review Process

The MDA will review the application, and additional information or clarification may be requested during this stage.

Approval and Certificate Issuance

Once the MDA is satisfied with the application, Medical Device Registration Certificate will be issued.

Post-Market Obligations

After obtaining approval, manufacturers and authorized representatives must comply with post-market obligations, including reporting adverse events and maintaining a vigilance system.

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