Malaysia Unregistered Route for Export-Only & Diagnostics-Only Devices
MDA shed the light on the following statistics:
Total establishment license: 2,300 Establishments;
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:
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