The Thai Food and Drug Administration Office (TFDA) has adjusted control measures for the diagnostic test kits and related reagents for SARS-CoV-2 (COVID-19) detection to align with the risk levels of medical devices. The previous requirements for technology assessment and related standards for manufacturers or importers of COVID-19 test kits
The Thai Food and Drug Administration (FDA) issued an infographic regarding the guideline for registration of notified medical device for diagnostic test kits and reagents for SARS-CoV-2 (COVID-19). The infographic (in Thai) can be accessed here. The main idea of this infographic is referred from the Ministry of Public Health
This new draft is a derivative of the Presidential Regulation No. 28 Year 2024 and contains 282 articles which regulates the health supplies. It defines that Health Supplies are all materials and equipment necessary for Health Efforts such as Pharmaceutical Preparations, Medical Devices, and other Health Supplies according to the
Last April 25, 2024, the Indonesia Ministry of Communication updated the list of the laboratories/testing centers indicated in Decree No. 109 of 2024. This decree refers to the Determination of an Overseas Testing Centre for Certification Purposes of Telecommunication Devices and/or Equipment issued by the Director General of Resources Management
The General Director of Pharmacy and Medical Devices signed a circular letter No. HK.02.02/E/1753/2024 on 09 September 2024, regarding the implementation of the Good Distribution Practice of Medical Device (GDPMD) Certificate as a mandatory requirement for listing in the e-Catalogue system. The circular letter highlights the following information: 1. Every
The Minister of Communications and Informatics signed a New Decree Number 260 of 2024 concerning the Technical Standards of Short-Range Devices (SRD) on 13 May 2024. The regulated SRDs are as follows: 1. Bluetooth IEEE 802.15.12. Near Fields Communications (NFC)3. Radio frequency Identification (RFID)4. Ultra-wide bands (UWB)5. Low-Rate Wireless Personal
Subscribe to our Newsletter
Be the first to know about critical medical device regulation changes, market entry requirements, and industry shifts.
