Following the authority conferred by Section 5(1) of the Medical Device Act B.E. 2551 (2008) and Section 41(7) as amended by the Medical Device Act (No. 2) B.E. 2562 (2019), the Minister of Public Health hereby issues the following announcement: The registrant shall prepare signage to display the supervisor’s name
On May 20, 2024, the Ministry of Public Health of Thailand issued a notification governing medical devices that require Supervisors for Control of Production, Import, or Sale and the qualifications, number, and duties of such supervisors, B.E. 2567 (2024). Medical device operators must appoint at least one supervisor with qualifications
Effective 1st July 2024, a new registration initiative – NextGen MD, is available for product owners who are keen to market their next-generation MDs/IVDs in Singapore. The registration requirements follow the latest GN-15: Guidance on Medical Device Product Registration, with an additional task of completing the NextGen MD form. This
In a newsletter article last June 28, 2024, the Thailand Food and Drug Association (TFDA) shared news that they will be collaborating with agencies to discuss the draft of medical device laws to adjust the registration of diagnostic test kits and reagents for COVID-19 to be based on risk classification
The procurement process through the e-Catalogue website of the the Procurement Goods/Services (LKPP: Lembaga Kebijakan Pengadaan Barang dan Jasa Pemerintah) under the Ministry of Health (MoH) of Indonesia has been updated. The MoH has extended the listing deadline until 31 December 2024. In addition, the Freezing and Unfreezing process in the
On April 25, 2024, the Ministry of Public Health (MOPH) announced the Criteria, Methods, and Conditions for Assembly to Install Medical Devices Outside the Place Specified in the Certificate of Establishment, License, Notification license, or Listing License, B.E. 2567 (2024). The registrant, licensee, notifier, or the listing licensee who assembles
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