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On March 1st 2023, the MDA released the First Edition Guideline Document “Notification of Custom-Made Medical Devices” (MDA/GD/0064). This guidance document is intended to provide guidance for the requirements of custom-made medical devices that are eligible to be exempted under Medical Order 2016.   It also specifies the specific requirements and notification process to obtain permission …

Malaysia: MDA Issued the First Edition Guidelines on “Notification of Custom-Made Medical Device” (MDA/GD/0064) Read More »

On 23 December 2022, Malaysia’s Medical Device Authority (MDA) has released a draft guidance document for the requirements of application of certificate of free sale (CFS), manufacturing certificate (MC) and certificate of free sale for export only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 This draft guidance document will serve as a revised version of MDA/GD/0045 that was …

Malaysia: Draft guidance for requirements on certificate application of CFS, MC and CFS EO medical devices Read More »

On 13 December 2022, the Medical Device Authority of Malaysia (MDA) has published an announcement to emphasize the requirement for applying renewal of establishment license. The establishments (local manufacturer, authorized representative, distributor, and importer in Malaysia) shall apply for renewal of its establishment license at least 90 days before the expiry date of the licence, …

Malaysia: Latest License Terms For Renewal Establishment License By The MDA Read More »

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 issuance of MDA Circular Letter …

Malaysia: Medical Device Authority (MDA) Amends Policy for Control over Orphaned, Obsolete and Discontinued Medical Devices Read More »

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 of May 9th 2022 and …

Malaysia: Medical Device Authority (MDA) Improves the Policy for Control of Medical Device Refurbishment Read More »

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 be effective on the same …

Malaysia: MDA Announced Exemption of Conformity Assessment Process for the Registration of Covid-19 Test Kit Read More »