On July 18, 2025, the Thai Food and Drug Administration (FDA) issued a press release clarifying the differences between the Document Addition System (Upgrade to Full CSDT) and the Renewal System within SkyNet, the regulatory platform for medical device registrations. This clarification is critical for stakeholders managing existing licenses or
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
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