In October 2024, the Ministry of Health (MoH) of Vietnam issued Circular 19/2024/TT-BYT, which promulgates the list of medical devices assigned Harmonized System (HS) codes. This update follows Circular 31/2022/BTC on Vietnam’s nomenclature of exports and imports. The new circular takes effect from November 16, 2024, and replaces the previous
On November 22, 2024, the Thai FDA published an infographic on its official website, providing clarity on the classification of vehicles and medical equipment as medical devices under Thailand’s Medical Device Acts. Vehicles: Not Classified as Medical Devices The infographic specifies that the following vehicles are not considered medical devices
The Ministry of Health in Indonesia has announced a temporary closure of its medical devices licensing system and online certification platform for maintenance purposes, as outlined in Announcement No. FR.03.01/E.V/2653/2024, dated December 11, 2024. System Closure Details Medical Device Licensing System The medical device online registration system (REGALKES) available at
The Food and Drug Administration (FDA) has announced the implementation of a new schedule of fees and charges under Administrative Order No. 2024-0016. For over two decades, the FDA’s fees were governed by Administrative Order No. 50 s. 2001. The restructuring of fees aims to align charges with the costs
On November 27, 2024, the Philippine Food and Drug Administration (FDA) released Administrative Order No. 2024-0015, introducing updated regulations on the License to Operate (LTO) requirements for health product establishments. This includes rules for initial applications, renewals, and variations, applicable to medical device distributors (importers, exporters, wholesalers), manufacturers (including packers,
The Philippine Food and Drug Administration (FDA) has concluded the pilot implementation of the Certificate of Medical Device Notification (CMDN) application process through the eServices Portal System. This initiative, outlined in FDA Advisory No. 2024-1089, applied exclusively to applicants within the National Capital Region (NCR). The FDA has issued the
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