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
The Minister of Health of Indonesia has established regulation Number 3 of 2024 about Guidelines on Halal Manufacturing Methods for Drugs, Biological Products, and Medical Devices, as well as The Inclusion of Information on The Origin of Materials for Medical Devices on 5th March 2024 and stipulated on 2nd April
On August 2, 2024, the Food and Drug Administration (FDA) released an advisory regarding the implementation guidelines for a platform for submitting CMDN applications. FDA is currently developing the FDA eService’s Portal System – an online platform for a streamlined initial application of a Certificate of Medical Device Notification (CMDN).
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