Malaysia: MDA Announced Medical Device (Exemptions) Order of 2024

On March 7th, 2024, the Medical Device Authority (MDA) of Malaysia, issued Medical Device (Exemptions) Order 2024 where the Medical Device (Exemption) Order 2016 [P.U. (A) 103/2016] is revoked. The legislation covers the following:

Exemption from Registration of Medical Devices
Any medical device is exempted from registration under section 5 of the Act by the Minister if the medical device is:

1. for the purpose of personal use;
2. for the purposes of demonstration for marketing;
3. for the purposes of education;
4. for the purposes of clinical research;
5. for the purposes of performance evaluation of medical device;
6. for the purposes of export only;
7. for the purposes of import for re-export;
8. a custom-made medical device;
9. a special access medical device;
10. an orphaned medical device;
11. an obsolete medical device; or
12. a discontinued medical device.

A request for an exemption must be submitted to the Authority in the format and way decided by the Authority by anyone who imports, exports, manufactures, or places any medical device exempt on the market.

Exemption from Establishment Licence

A person who imports or exports any medical device mentioned in paragraph 3 of the order—with the exception of special access medical devices—is exempted from subsection 15(1) of the Act’s establishment license requirement by the Minister.

Exemption from Conformity Assessment for Class A Medical Device
Class A medical device is exempted from the conformity assessment procedures by a conformity assessment body under the section 7 of the act.

Further information of this order can be accessed here Gazette of Medical Devices (Exemption) Order 2024 (mda.gov.my) and P.U. (A) 78_2024.pdf (mda.gov.my).

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