Regulatory updates Archives

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

September 10, 2024

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

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

September 10, 2024

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

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

September 10, 2024

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

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

Regulatory Updates

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

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

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

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)

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