September 2024

Regulatory Affairs Update: Thailand

Thailand: Cancellation of Listing Approval Certificate due to Incorrect Risk Classification Category

The Thai Food and Drug Administration issued an infographic regarding an occurrence that may result in the cancellation of the listing approval certificate.  According to the Ministry of Public Health Notification, manufacturers and importers must submit a listing application for a device, an apparatus, a machine, an object inserted into the body, a solution used

Thailand: Cancellation of Listing Approval Certificate due to Incorrect Risk Classification Category Read More »

Regulatory Affairs Update: Indonesia

Indonesia: Issuance of Regulation governing the Certification of Telecommunication Devices and/or Telecommunication Equipment

The Minister of Communications and Informatics in Indonesia issued regulation No. 3 of 2024 concerning Telecommunication Device and/or Telecommunication Equipment Certification. This regulation consists of 62 articles that describe and regulate the requirements applied in the certification process of telecommunication devices and/or equipment. As stated, any telecommunication device and/or equipment manufactured, assembled, or imported for

Indonesia: Issuance of Regulation governing the Certification of Telecommunication Devices and/or Telecommunication Equipment Read More »

Regulatory Affairs Update: Vietnam

Vietnam: Notice of Domain Change for the Online Public Service System for Medical Device Management

The Department of Infrastructure and Medical Equipment announced the change of the domain name for the Online Public Service Portal on Medical Equipment Management in Vietnam as below: Old Domain: https://dmec.moh.gov.vn New Domain: https://imda.moh.gov.vn Implementation Timeline: From September 1, 2024, until December 31, 2024, both the old and new domains will be maintained simultaneously for

Vietnam: Notice of Domain Change for the Online Public Service System for Medical Device Management Read More »

Regulatory Affairs Update: Vietnam

Vietnam: Issuance of Draft Circular for Declaring the Prices of Medical Devices

The Vietnam Ministry of Health issued a draft Circular on Regulations for Declaring the Prices of Medical Devices, which will cover the following aspects: The economic and technical characteristics of medical devices for price declaration; and The receiving Authority and entities responsible for declaring the prices of medical devices. The list of medical devices for

Vietnam: Issuance of Draft Circular for Declaring the Prices of Medical Devices Read More »

Regulatory Affairs Update: Indonesia

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

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 test Report from Overseas could

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

Regulatory affairs update: Singapore

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

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 throughout SaMD total product lifecycle

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

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 the manual for requesting permission

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

Regulatory Affairs Update: Thailand

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

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 devices in an exaggerated manner,

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

Scroll to Top

Contact Us

Stay Ahead in Southeast Asia's Medical Device Market!

Subscribe to our Newsletter
Be the first to receive essential updates on regulatory changes, market trends, and industry insights from us!

Andaman Medical - Mar Socials 2025 (11)