Draft guidance for requirements on certificate application of CFS, MC and CFS EO medical devices
On 23 December 2022, Malaysia’s Medical Device Authority (MDA) has released a draft guidance document for the requirements of application of certificate of free sale (CFS), manufacturing certificate (MC) and certificate of free sale for export only (CFS EO) medical devices. This draft guidance document will serve as a revised version of MDA/GD/0045 that was released and became effective previously on November 2018. The draft guidance is currently up for comments by the stakeholders until 13 January 2023.
The draft guidance will provide assistance to applicants who wish to apply for Certificate of Free Sale (CFS), Manufacturing Certificate (MC) and Certificate of Free Sale for Export Only (CFS EO) of medical devices in compliance with the Medical Device Act (Act 737), and for medical devices that fall under the Circular Letter of Medical Device Authority No. 4 Year 2018, Exemption from Registration Requirement for Export Only Medical Device.
In this draft guidance, it is also mentioned that once the certificate is issued, no amendments is allowed and a new application must be made. The information in the certificate will be according to the information submitted in the certificate application. Any errors to the certificate issued shall be notified by the applicant within 90 days from the date of issuance.
For more information, see the Public Comment Draft Guidance Document for the application of licensing for application of certificate of free sale (CFS), manufacturing certificate (MC) and certificate of free sale for export only (CFS EO) medical devices.
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