Malaysia Unregistered Route for Export-Only & Diagnostics-Only Devices


MDA shed the light on the following statistics:

Total establishment license: 2,300 Establishments;

Manufacturers: 230

Authorized Representatives: 1,500

Distributors and importers: 600

Total Medical Device Registered: 580,000 Devices

On top of class A medical Devices being exempted from Conformity Assessment procedures by the Conformity Assessment Body, the Malaysia MDA has also recently announced the exemption of export only medical devices from registration under Section 5 of Act 737. In addition to the exemptions, MDA has also provided updates to the following guidance documents for:

  • Import And.or Supply of Unregistered Medical Devices for the Purpose of Demonstration for Marketing or Education - Permission is valid for only 90 days from the date of importation.

  • Requirements for Application of Certificate of Free Sale (CFS) for Export Only Medical Devices - Abridged requirements.

For more information on the guidance documents, check out the following links:

- IMPORT AND/OR SUPPLY OF UNREGISTERED MEDICAL DEVICES FOR THE PURPOSE OF DEMONSTRATION FOR MARKETING OR EDUCATION

- REQUIREMENTS FOR APPLICATION OF CERTIFICATE OF FREE SALE (CFS) FOR EXPORT ONLY MEDICAL DEVICES

Contact us at info@arqon.com.


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