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 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
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
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
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
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
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