• 2024-10-10 08:23:53

The Thai Food and Drug Administration (FDA) has initiated a registration process for Mpox diagnostic test kits in response to rising concerns over the spread of the viral infection. This move aims to enhance early detection and management of Mpox cases, ensuring public health safety. The Thai FDA has streamlined the registration process for manufacturers and importers, focusing on quality and accuracy of the diagnostic kits. This initiative is a key step in Thailand's efforts to curb the spread of the virus and strengthen its response to emerging health threats.

• 2024-09-17 03:17:46

Indonesia's Ministry of Health has issued Regulation No. 3 Year 2024 as a new derivative to the previous halal regulations on medical devices, providing a more specific outline on the mandate for medical device halal certification. This regulation introduces stringent requirements for manufacturing, labeling, and material disclosure.

• 2024-06-19 06:08:37

The Indonesian Ministry of Health recently issued guidelines to regulate the use of Medical Devices and Household Health Supplies through electronic systems. These guidelines, signed on 5 April 2024, offer crucial information for business actors, manufacturers, and distributors in the healthcare sector seeking to market their products in electronic systems.

• 2024-04-03 09:16:23

The Philippine Food and Drug Administration (PFDA) released an advisory on March 06, 2024 announcing that COVID-19 Medicines and Devices will no longer be VAT-exempt, effective 01 January 2024. This is due to the expiration of the VAT exemption provision in the CREATE Act.

• 2024-03-01 05:58:09

Decision No. 04/QD-BYT dated January 2, 2024 of the Vietnam Ministry of Health assigning Conformity Assessment Bodies for evaluation of Common Submission Dossier Template.

• 2024-01-26 07:08:51

A regulation on the management of emergency use of medical devices (trial) is issued.

• 2023-09-27 07:23:16

Indonesia released a new Omnibus Health Law No. 17/2023, which was ratified on August 8, 2023, in the House of Representatives’ Plenary Session. The law discusses health regulations in general, including medical devices and healthcare.

• 2023-07-21 02:49:56

Hong Kong's Department of Health will adopt a new strategy taking effect on 21 June 2023, to give preference to medical devices (MD) listed under the Medical Device Administrative Control System (MDACS) in the procurement of all applicable medical devices.

• 2023-02-23 01:45:57

A pilot run for new requirements on the procurement of medical devices by the Department of Health (DH) will be implemented with effect from 1st October 2022. Under the pilot run, medical devices purchased by Department of Health should preferably be listed under MDACS.

• 2023-02-23 01:39:29

The Procurement Bureau of the Ministry of Health and the National Public Procurement Agency plan to expand E-purchasing access for private health facilities participating as National Health Insurance (in Indonesia known as JKN) providers for transactions of medical devices in the e-katalog starting from January 2023.