MDA TO CEASE THE ISSUANCE OF CERTIFICATE OF FREE SALE (CFS) FOR EXPORT ONLY MEDICAL DEVICE

 

MEDICAL DEVICE AUTHORITY

 

MDA TO CEASE THE ISSUANCE OF CERTIFICATE OF FREE SALE (CFS) FOR EXPORT ONLY MEDICAL DEVICE

 

Dear Valued Clients,

Effective 1^st October 2023, please be informed that a Certificate of Free Sale (CFS) will only be issued for registered medical devices, following the announcement made by Chief Executive of MDA during MDA High Performance Project on 7^th 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 for establishment who wishes to export the export only medical device from Malaysia as part of the process to register or import a product into that country. The issuance of Export Certificate is not a mandatory requirement under the 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 effective date of Export Certificate is valid until the expiration date of the certificate. For more information on how apply for Export Certificate, please  (Click HERE).

For any inquiries, kindly contact us at exportonly.ec@mda.gov.my or Mdm Norhafizah 03-82300208/ Mr Fezri 03-82300395/ Mr Shahrezza 03-82300392.

 

Thank you.

Medical Device Authority

Ministry of Health, Malaysia

23^rd October 2023