On July 18, 2025, the Ministry of Public Health, acting on the recommendation of the Medical Device Committee, issued an announcement revising the official list of designated inspection points for imported medical devices. This update repeals and replaces the previous Announcement dated December 14, 2023 (B.E. 2566). To view the
On July 21, 2025, the Vietnam Ministry of Health issued Official Dispatch No. 4755/BYT-HTTB to solicit public and stakeholder feedback on the Draft Circular concerning the issuance of a national centralized procurement list for medical devices and testing supplies. This draft, prepared by the Infrastructure and Medical Device Administration (IMDA),
On July 16, 2025, the Ministry of Health Malaysia announced the launch of the Medical Device Regulatory Reliance Programme with China. This landmark initiative, revealed during the HIMSS Asia-Pacific Health Conference & Exhibition 2025 in Kuala Lumpur, marks a strategic breakthrough in accelerating patient access to safe and innovative medical
On July 2025, the Health Sciences Authority (HSA) released a new revision to existing guidance titled GN-09: Guidance on the Component Elements of a Dear Healthcare Professional Letter (DHCPL). To view the official guidance document, refer to: GN-09: Guidance on the Component Elements of a Dear Healthcare Professional Letter Key
A new regulation was issued by the Minister of Health on 18 July 2025, establishing the criteria for medical devices that may be sold in the retail market. The criteria are as follows: The product holds a valid Distribution License Number (Nomor Izin Edar/NIE) Classified as a low-risk medical device
This process applies to medical support devices that have received a Letter of Notification (Surat Keterangan Informasi Produk/SKP-IP) from the Ministry of Health, stating that the product is not classified as a medical device. These products are used in health services in accordance with their intended function. To view the
Subscribe to our Newsletter
Be the first to know about critical medical device regulation changes, market entry requirements, and industry shifts.
