The Health Sciences Authority (HSA) Singapore has initiated a new optional regulatory pathway – Change Management Program (CMP), specifically for SaMD that is incorporated into HSA’s Premarket Product Registration and Change Notification (CN) processes. CMP’s eligibility requires mandatory and valid conformance to latest standards of ISO 13485 and IEC 62304
Medical Device Control Division would like to inform entrepreneurs to follow the guidelines for displaying warnings, prohibitions, and precautions in advertising medical devices in accordance with the Thai FDA announcement. The criteria, methods and conditions for issuing licenses and medical device advertising license 2021 (B.E. 2564), with details according to
On August 27, 2024, Thailand FDA published an infographic about Medical Device Advertisement on their official Facebook page. Here are some examples of “text, images, or advertising” that are “not allowed” in advertising medical devices: Using words or statements about the benefits, quality, quantity, standards, ingredients, or origin of medical
The Medical Device Authority of Malaysia (MDA) has announced that expired EC Certificates under certain EU Directives (90/385/EEC, 93/42/EEC, 98/79/EC) or declarations of conformity for Class B IVD devices under Directive 98/79/EC can be used for conformity assessment by registered conformity assessment bodies (CABs). This approach addresses delays in transitioning
On August 16, 2024, the Department of Medical Infrastructure and Equipment issued an announcement to registration facilities regarding the update of documents on the DMEC website. The Department requires registration facilities to follow up the processing progress and update the documents on the system as per the following guidelines: Instructions
On August 20, 2024, Thailand FDA published an infographic about the registration of diagnostic tests for Monkeypox (Mpox) in Thailand. The information shared is as follows: ● Monkeypox Diagnostic Test is categorized as Medical devices for in vitro diagnostics (IVD) group and classified as Notify medical devices (Class B or
Subscribe to our Newsletter
Be the first to know about critical medical device regulation changes, market entry requirements, and industry shifts.
