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On September 5th 2022, the MDA released two First Edition Guidance Document: “Harmonized Classification of Medical Devices In ASEAN” (MDA/GD/0062) and the First Edition Guidance Document: “Harmonized Borderline Products in ASEAN” (MDA/GD/0063). These guidance documents are mostly concerned with: Harmonized list of risk classification of medical devices including in-vitro diagnostic (IVD) medical devices based on […]

The Medical Devices Authority (MDA) has joined Operation Pangea XV from June 22 to July 05, 2022, which is a worldwide campaign operation to carry out large-scale enforcement actions against the sale of counterfeit and illicit medicines and medical products. This operation is coordinated by the International Criminal Police Organization (Interpol) with the involvement of

On July 14th 2022, the MDA announced Medical Device Centralized Reporting System (Medcrest) is ready to be used by an establishment of a medical device. All Mandatory Problem Reporting, Field Corrective Action and Device Recall can be done online using the Medcrest system starting July 15th, 2022. This new system can be accessed through the

MDA would like to inform that the Medical Device (Responsibility & Establishment) Regulations 2019 will be fully enforced, effective July 1, 2022. With the full enforcement of these rules, it means that all parties involved in the importation, distribution, and placement of medical devices in the market are required to comply with all the post-market

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 edition are as follows: Clause

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 be carried out smoothly, the

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

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

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

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, found individuals and health facilities

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 Act 737 and MDR 2012

Learn about the updates to dental laboratory regulatory requirements, as announced by Health Sciences Authority (HSA) Singapore on 10th May 2021.

Malaysia’s Medical Device Authority (MDA) published the 2nd Edition GUIDANCE ON THE RULES OF CLASSIFICATION FOR GENERAL MEDICAL DEVICES MDA/GD/0009 on 9th May 2022.   The document aims to provide clear guidance to manufacturers and establishments on how to determine the classification of medical devices. It also aims to allocate its medical device to an appropriate