On September 11 and October 13, 2025, the Malaysian Medical Device Authority (MDA) issued a revised guide for the conformity assessment procedure and submission of medical device registration applications.
In Malaysia, Class A medical devices are exempt from the conformity assessment procedure. However, for Class B to D medical devices, a conformity assessment must be conducted prior to registration to ensure compliance with legal requirements. This assessment must be performed by a designated Conformity Assessment Body (CAB) to ensure that the medical device meets the Essential Principles of Safety and Performance, However, this process is time-consuming.
Therefore, the MDA has established a policy to streamline the conformity assessment procedure for medical devices approved in MDA-recognized countries, and Singapore and Thailand have recently been added to this list.
Medical devices approved in the following countries are eligible to undergo the simplified conformity assessment process through the verification pathway.
1) Europe (EU NB): Class IIa / Class B IVD / Class IIb / Class III / Class C IVD / Class D IVD
2) Japan (MHLW): Third-party pre-market certification (Ninsho) / MHLW pre-market approval (Shonin)
3) Australia (TGA): ARTG certification
4) Canada (HC): HC License
5) United States (FDA): 510(k) clearance / PMA
6) United Kingdom (MHRA): UK Conformity Assessed (UKCA) / EC certificates issued based on approvals recognized by EU NB
7) Singapore (HSA): Registered in the Singapore Medical Device Register (SMDR)
8) Thailand (TFDA): Class 2-3 (CMDN) / Class 4 (CMDL)
For medical devices approved in MDA-recognized countries, the registration process in Malaysia can be completed in a shorter timeframe.
Please refer to the attached document below.
If you have any questions about medical devices,
please contact us with the below.
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