The Malaysian Medical Device Authority (MDA) has released the 4th edition of Guidelines for Registration of Drug-Medical Device and Medical Device-Drug Combination Products on 25 October 2021. The main changes are the inclusion of new Post Marketing Surveillance procedures for Combination Products in Malaysia namely the management of incidents involving
Vietnam’s Ministry of Health introduced new regulations on 16 September 2021 regulating the issuance of fast-track product licenses and the importation of medical equipment for COVID-19 prevention and control. Circular No. 13/2021/TT-BYT immediately came into effect from the date of signing and is effective until 31 December 2022. The Circular
The Malaysian Medical Device Authority (MDA) now allows for multiple authorized representatives for medical devices. This was announced on 14 September 2021, by repealing Circular Letter No. 1/2014 for Establishments Carrying Out the Role as an Authorized Representative (AR) and Establishments Carrying Out Various Activities, which was effective as of
The Health Sciences Authority (HSA) Singapore has adopted the Medical Device UDI system. This came into effect on 27 August 2021 with the issuing of new UDI Submission Guidelines. The purpose of this system is to improve registered medical devices’ traceability by: Enabling timely identification of devices affected by recalls,
The Ministry of Health in Vietnam will officially require the use of the Common Submission Dossier Template (CSDT) for all new class B, C, and D medical device registrations as of 01 January 2022. This requirement was published in Decision No. 2426/QDBYT on 15 May 2021 and came into effect
The Singapore Health Sciences Authority (HSA) has issued draft regulatory guidelines on the Classification of Software as a Medical Device that are open for consultation by stakeholders. Comments may be submitted until 19 August 2021. The draft guidelines cover the classification of non-IVD standalone mobile medical device applications commonly known
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