Regulatory Updates

On 22 June 2022, Malaysia’s Medical Device Authority (MDA) has released The Fifth Edition Guidance for Labeling on Registered Medical Devices. The purpose of the document is to provide guidance to manufacturers and authorised representatives on the content of medical device labelling. This amendments from the fourth edition to fifth

The MDA has informed the public that they will give transition period until 31 December 2022 to the establishment for compliance with the requirements set out in the guidance document “Requirements for Labelling of Medical Devices (MDA/GD/0026), Fifth Edition”. To ensure that the importation and distribution of medical device could

On June 16th 2022, the MDA has announced an amendment to the policy for control of orphaned, obsolete and discontinued medical devices in any facility including hospitals and health facility institutions.   Originally contained in PBPP Circular Letter No. 2 of 2018 (Revision 2) the amendment was passed through the

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