Overview of Malaysia regulatory framework
Medical devices in Malaysia are regulated by the Medical Device Authority (MDA) under the Ministry of Health. The regulatory framework is based on the Medical Device Act 2012 (Act 737), Medical Device Authority Act 2012 (Act 738), and Medical Device Regulations 2012.
Medical devices in Malaysia are classified into Class A, B, C and D by risk level. For each registration, A Conformity Assessment must first be carried out by the Conformity Assessment Body (CAB) in Malaysia. Class A devices are exempt from this requirement.
Regulatory routes for medical devices in Malaysia
Products approved in the European Union, the United Kingdom, Australia, Canada, Japan and the United States are eligible for a brief review or “validation.” Products that do not qualify must undergo a full conformity assessment by the CAB, similar to a review by an EU notified body. Once the conformity assessment has been completed and the CAB has issued a certificate and audit report, the application for registration can be submitted. It is possible to register without reference country approval, but a full assessment will be required.
Key resources for Malaysia device Registration
As you begin the Malaysia registration process, here are some helpful links:
- Medical Device Authority
- MEDCAST
- Medical Device Act of 2012
- Medical Device Regulations of 2019 (link in Bahasa Malaysia)
- ASEAN Medical Device Directive
- MDA guidance: Medical Device Labelling
- MDA guidance: Distribution Records
- MDA guidance: Mandatory Problem Reporting
- MDA guidance: Complaint Handling
- Field MDA guidance: Corrective Actions (FCA)
- MDA guidance: Medical Device Recalls
