Regulatory Updates

Regulatory affairs update: Thailand

Thailand: Thai FDA Shares Criteria, Methods and Conditions for Issuing Licenses and Medical Device Advertising License 2021 (B.E. 2564)

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

Regulatory Affairs Update: Malaysia

Malaysia: MDA’s Approach to Expired EC Certificates and Self-Declared for New Registration and Re-Registration of Class B IVD Medical Devices

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

Regulatory Affairs Update: Vietnam

Vietnam: Announcement Regarding the Update of Documents on the DMEC System

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

Regulatory Affairs Update: Thailand

Thailand: FDA Shares Information for the Registration of Monkeypox Diagnostic Test

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

Regulatory Affairs Update: Indonesia

Indonesia: Minister of Health Issued a New Regulation Pertaining to Guidelines on Halal Manufacturing Methods for Drugs, Biological Products, and Medical Devices, as well as the Inclusion of Information on the Origin of Ingredients for Medical Devices

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

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