Regulatory updates Archives

Thailand: Announcement of the Timelines for the Implementation Quality System for Importing or Selling of Medical Devices B.E.2566 (2023) in Thailand

January 17, 2024

To ensure the standardized quality, efficiency, and safety of importing or selling medical devices, which is in the interest of consumer protection, it is appropriate to establish a Quality Management System for Importing or Selling Medical Devices. This announcement shall become effective after 1 year from the date of publication

Thailand: Draft Guidance for the Production of Medical Devices that are Exempted under Section 27(8) B.E. 2008 in Thailand

January 17, 2024

The Ministry of Public Health (MOPH) in Thailand issued a draft guidance on criterions, procedures, and conditions for the production of medical devices that are exempt under Section 27(8) B.E. 2008. The key points of the draft guidance are as follows: 1. Production of medical devices by a government agency

Vietnam: Temporary Freezing of the Online System for Submission of Class C and D Medical Devices by the Ministry of Health

January 17, 2024

On 31 December 2023, the Ministry of Health (MoH) of Vietnam temporarily froze the online system for the submission of class C and D medical devices. The DMEC website is currently under maintenance starting 01 January 2024 in order to implement the CSDT in accordance with Decree 07/2023/NĐ-CP amending some articles of

Singapore: Announcement on the List of Regulatory Fee Revision for Health Products

January 17, 2024

The Health Sciences Authority (HSA) of Singapore announced regulatory fees revision pertaining to health products including medical devices, to be effective on 1 July 2024. The HSA continues to absorb the 1% Goods and Services Tax (GST) increment which was implemented on 1 Jan 2023 and 1 Jan 2024, until

Philippines: PFDA Announced Accredited Technical Service Providers for Radiation Dosimetry of Individual Monitoring

January 9, 2024

On December 29, 2023, PFDA issued Circular No. 2023-012, listing Accredited Technical Service Providers for Radiation Dosimetry of Individual Monitoring Services. Aligned with DOH AO No. 2020-0035, PFDA oversees facilities using radiation devices to safeguard workers. Emphasizing adherence, PFDA requires providers to establish formal procedures for approval, recognition, or authorization

Singapore: HSA Warns On Cybersecurity Vulnerabilities Potentially Affecting Medical Devices Using 5G Modems

January 3, 2024

On 15 December 2023, Health Sciences Authority (HSA) Singapore issued a medical device advisory to alert industry stakeholders to cybersecurity vulnerabilities known as “5Ghoul”. “5Ghoul” affects commercial off-the-shelf (COTS) edge devices using 5G modems. Medical device systems using 5G modems for internet connectivity to function could be attacked in the

Regulatory Updates

Thailand: Announcement of the Timelines for the Implementation Quality System for Importing or Selling of Medical Devices B.E.2566 (2023) in Thailand

Thailand: Draft Guidance for the Production of Medical Devices that are Exempted under Section 27(8) B.E. 2008 in Thailand

Vietnam: Temporary Freezing of the Online System for Submission of Class C and D Medical Devices by the Ministry of Health

Singapore: Announcement on the List of Regulatory Fee Revision for Health Products

Philippines: PFDA Announced Accredited Technical Service Providers for Radiation Dosimetry of Individual Monitoring

Singapore: HSA Warns On Cybersecurity Vulnerabilities Potentially Affecting Medical Devices Using 5G Modems

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