Government issues new Medical Device Exemption Order

The Malaysian Minister of Health has issued a new Medical Device (Exemption) Order 2024 [P.U.(A) 78/2024] (“Exemption Order”) which came into operation on 6 March 2024. This Exemption Order revokes and replaces the Medical Device (Exemption) Order 2016 [P.U.(A) 103/2016].
Significant changes include additional categories of medical devices which may qualify for exemption from registration under the Medical Device Act 2012, as well as enhanced definitions for key terms.
Several categories of devices which previously would have qualified for the exemption from registration upon notification to the Medical Device Authority (“Authority”) now require an application for exemption to be submitted the Authority. Nonetheless, any exemption previously made under the Medical Device (Exemption) Order 2016 continues to be in force until amended or revoked.
The following summarises the exemptions from medical device registration based on this latest Exemption Order.
The categories of medical devices listed in paragraphs (f), (g), (j), (k) and (l) of the Table above are new categories of exemptions introduced under the Exemption Order.
Importers or exporters of exempted devices are also exempted from establishment licence requirements, except for those importing or exporting special access medical devices for whom the licensing requirement remains.
As before, Class A medical devices continue to be exempted from conformity assessment procedures.
Alert by Melissa Long (Partner) of the Product Regulatory and Compliance Practice of Skrine.

This alert contains general information only. It does not constitute legal advice nor an expression of legal opinion and should not be relied upon as such. For further information, kindly contact