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
The Thai Food and Drug Administration (TFDA) implemented a new notification aimed to simplify the registration process of medical devices under the “Specification of Data, Documents, or Evidence Not Required for Submission under the Ministerial Regulations on the Permission and Issuance of Licenses for the Manufacturing or Importation of Medical
On June 4, 2024, the Thailand Food and Drug Administration (TFDA) announced the list of foreign agencies recognized or accepted for inspection or certification of medical devices or its establishments. The details are as elaborated below: No. Agency Condition 1 Therapeutic Goods Administration (TGA) It is a medical device that
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