Effectively from 1 October 2023, the Medical Device Authority (MDA) ceased the issuance of Certificate of Free Sale (CFS) for export-only medical devices, instead the CFS issuance is applicable only for registered medical devices. CFS for export-only (CFS-EO) medical devices that have been issued before the effective date of the Export Certificate, are valid until the expiration date.
According to the Circular Letter of Medical Device Authority No.4 Year 2018, medical devices for export only were exempted from the registration requirements under the Medical Device Act 2012 (Act 737) but required to submit notification to the Authority. The exportation activities were only allowed once the Authority issued the Export Only Medical Device Exemption Letter.
With that, MDA will release an Export Certificate to facilitate the export activity, including registration/importation procedures for export-only medical devices from Malaysia to foreign countries. Exporters should note that this certificate is not a mandatory requirement from MDA.
Application Process
Exporters are required to acquire an Export Only Medical Device Exemption Letter before proceeding to apply for an Export Certificate. Turn-around time for the process with complete documentation is 14 working days. The required supporting documents are:
Export certificate application form
Export Only Medical Device Exemption Letter by MDA
Medical Device list
Medical device label (provided accordingly to the importing country information as stated in the application form)
Attestation
Issuance of Export Only Medical Device Exemption Letter
MDA will issue the Export Only Medical Device Exemption Letter within 14 days upon completed payment, via email and letter. The period validity for the letter is five (5) years and allows for multiple export consignments. No exportation activity to the medical devices stated in the letter is allowed once the exemption letter reaches the expiration.
Source: Medical Device Authority (MDA)
Contact us at info@arqon.com for more information.