Based on the Decision from the Mesyuarat Jawatankuasa Teknikal Pendaftaran Umum 2023, the Medical Device Authority of Malaysia (MDA) has established a transition period for specific requirements until December 31, 2023. Starting January 1, 2024, only the recognized Quality Management System (QMS) standards outlined in Table 1 will be accepted
On 26th October 2023, the Medical Device Authority of Malaysia (MDA) published an announcement on the implementation of the use of electronic medical device registration certificate beginning November 1, 2023. With this move for applications approved after 1 November 2023, only electronic medical device registration certificates will be issued by
On 23rd October 2023, the Medical Device Authority of Malaysia (MDA) published an announcement that the Certificate of Free Sale (CFS) will only be issued for registered medical devices, following the announcement made by the Chief Executive of MDA during MDA High Performance Project on 7th June 2023. With this
The Health Sciences Authority (HSA) Singapore revised Guidance Document: GN-20 Guidance on Clinical Evaluation. The updates reflect their current position on the use of real-world data in medical device clinical evidence as well as clarify related contents with IMDRF guidelines. The HSA is currently soliciting industry comments for this revision.
On October 18th, 2023, the Thai Food and Drugs Administration (FDA) provided more explanation to the registration of medical devices scheme, by issuing a pamphlet that can be accessed here (in Thai language). The pamphlet emphasizes more on the registration process based on the risk classification of the medical devices,
On October 18, 2023, the Bureau of Goods and Services Procurement (or known as ‘PBJ Bureau’) of the Ministry of Health conducted a socialization on the implementation of Substitution of Imported Medicines and Medical Devices with Domestic Medicines and Medical Devices in the Sectoral e-Catalogue, in an effort to improve
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