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Malaysia: The MDA To Cease The Issuance Of Certificate Of Free Sale (CFS) For Export Only Medical Device

On 23rd October 2023, the Medical Device Authority of Malaysia (MDA) published an announcement that the Certificate of Free Sale (CFS) will only be issued for registered medical devices, following the announcement made by the Chief Executive of MDA during MDA High Performance Project on 7th June 2023.

With this move, MDA ceases the issuance of CFS for export only medical devices under the Circular Letter of Medical Device Authority No. 4 Year 2018. Instead, MDA will issue an Export Certificate (EC) for establishment that wishes to export medical devices for “export purposes” only from Malaysia as part of the process to register or import a product into that country. Based on the updated EC application process as of 25 October 2023, the applicant shall first obtain the Export Only Medical Device Exemption Letter that will be issued by the MDA. Further process can be accessed here.

The issuance of Export Certificate is not a mandatory requirement under Act 737. Rather, it is a service to facilitate the export of medical devices from Malaysia.

CFS for Export Only (CFS-EO) medical devices that have been issued before the effective date of Export Certificate is valid until the expiration date of the CFS-EO certificate. The ceasing of the CFS-EO has been made effective since October 1st, 2023.

Further information on this announcement can be accessed here.

If you have any queries regarding this announcement, please contact us or click the button below.

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