On June 16th 2022, the MDA announced that the policy for control of medical device refurbishment activities contained in PBPP Circular Letter Number 1 Year 2016 (Revision 2) has been improved through the issuance of MDA Circular Letter Number 3 Year 2022. The improvements to this policy are effective as

On June 13th 2022, the MDA has announced the exemption of conformity assessment process for registration of COVID-19 test kits either for personal or professional use via the Circular No.1/ 2022. The approval was decided during the MDA members meeting that was conducted on May 9th 2022. The implementation will

Any individual, company or health facility involved in providing medical services must apply for the Medical Device Registration and Establishment License, as defined in Sections 5 and 15 of the Medical Devices Act 2012 (Act 737). An investigation and subsequent results of the compliance monitoring activities conducted by the MDA,

First edition guidance on the re-registration of registered medical device was issued by the Ministry of Health Malaysia on 3 June 2022. The Medical Device Authority (MDA) published the guidance document to provide information and explanation to the establishment on how to submit re-registration of registered medical device application under