Medical Device Registration in Malaysia: MDA Requirements and Pathways
Medical device regulations in Malaysia are governed by the Medical Device Authority (MDA) under the Ministry of Health Malaysia (MoHM), as outlined in the Medical Device Act 2012. Registration with the MDA is mandatory before any medical device can be imported or placed on the market.
Government Authority and License Holder
- Regulator: The Medical Device Authority (MDA) is the government body responsible for administering the regulations.
- License Holder: Registration applications must be submitted via the online MEDCAST system by a licensed, local entity known as the Malaysia Authorized Holder (MAH). The MAH acts as the license holder on behalf of the foreign manufacturer.
- License Transfer: Licenses are transferable between Authorized Representatives (ARs) via an application on the MEDCAST portal, requiring a Termination Letter and a Letter of Authorization from the new AR.
Classification and Registration Routes
Malaysia's classification system aligns closely with the ASEAN Medical Devices Directive (AMDD) and GHTF guidelines, categorizing devices into four risk classes (A, B, C, and D), plus a fifth category for combination devices.
| Device Class | CAB Fees (MR/USD) | MOH Fees (MR/USD) | Review Times |
|---|
| Class A | n/a | MR100 / $21 | 6 to 8 weeks |
| Class B | MR1,300 / $273 | MR1,250 / $263 | 3 to 6 months |
| Class C | MR1,300 / $273 | MR2,500 / $525 | 3 to 6 months |
| Class D | MR1,300 / $273 | MR3,750 / $788 | 3 to 6 months |
Reliance and Provisional Registration
The MDA employs pathways that leverage approvals from other major regulatory jurisdictions:
- Reference Countries: Devices approved in one of the following reference countries are eligible for faster registration pathways: Australia, Canada, European Union, Japan, United States, Singapore, or Thailand.
- Fast Track System (Provisional Registration): For devices with reference country approval, the MDA may issue a provisional registration. This allows the device up to 5 years to submit the required Certificate of Conformity from a local, authorized Conformity Assessment Body (CAB).
- Regional Pilot Programs: Malaysia is actively participating in regional pilots, such as the Singapore–Malaysia Regulatory Reliance Pilot, aimed at accelerating access for eligible Class B, C, and D devices by relying on approvals from partner regulatory agencies.
Required Documentation
A key component of the registration application is the Certificate of Conformity from a local CAB, which verifies that the manufacturer meets the regulatory requirements. The entire submission process for Class B, C, and D devices involves the local CAB for assessment prior to submission to the MDA.
Anonymous
We are currently negotiating with three different distributors in Kuala Lumpur. To maintain maximum flexibility, we are hesitant to appoint one of them as our legal Authorized Representative (AR). If we appoint a third-party professional regulatory consultant as our AR, does the MDA allow us to link multiple distributors to that single registration? Also, who is legally responsible for reporting Adverse Events (AE) to the MDA in this setup?