Regulatory updates Archives

Indonesia: Issuance of Regulation governing the Overseas Testing Centre for Certification Purposes of Telecommunication Device and/or Equipment

September 10, 2024

Decree No. 109 of the Year 2024 concerning the Determination of an Overseas Testing Centre for Certification Purposes of Telecommunication Devices and/or Equipment was issued by the Director General of Resources Management and Equipment of Posts and Informatics under the Ministry of Communications and Informatics. According to the regulation, the

Singapore: Consultation on draft of Guidance on Change Management Program (CMP) for SaMD

September 4, 2024

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

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

September 4, 2024

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

Thailand: Thai FDA Shares Information for Prohibitions and Prohibited Messages in Advertising Medical Devices

September 4, 2024

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

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

August 28, 2024

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

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

August 22, 2024

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 Updates

Indonesia: Issuance of Regulation governing the Overseas Testing Centre for Certification Purposes of Telecommunication Device and/or Equipment

Singapore: Consultation on draft of Guidance on Change Management Program (CMP) for SaMD

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

Thailand: Thai FDA Shares Information for Prohibitions and Prohibited Messages in Advertising Medical Devices

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

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

Countries

Categories

Sign up for our regulatory roundup delivered once a month to your inbox

Main Pages

Address

E-mail Address

Phone Number

Stay Ahead in Southeast Asia's Medical Device Market!