On December 20, 2024, the Vietnam Ministry of Health (MoH) issued a draft amendment and supplement to several articles of Decree No. 98/2021/ND-CP, dated November 8, 2021, on Medical Devices Management. This draft follows previous amendments introduced by Decree No. 07/2023/ND-CP, dated March 3, 2023. The draft aims to enhance regulatory processes while addressing key […]
On December 16, 2024, the Indonesian Ministry of Health issued Notification Letter No. FR.03.01/E.V/2672/2024, classifying Dried Blood Spot as a medical device. This update provides significant regulatory implications for manufacturers, importers, and distributors of the product. Below is a detailed summary of the notification and its key requirements: Details of the Product and Its Classification
Indonesia: Notification of Dried Blood Spot Product Classification as a Medical Device Read More »
On December 9, 2024, the Vietnam Ministry of Health (MoH) issued Official Dispatch No. 7614/BYT-HTTB, addressing the supply of medical devices whose import licenses will expire on December 31, 2024. This notice outlines measures to ensure an uninterrupted supply of medical devices while emphasizing compliance with regulatory requirements. Key Actions for Medical Device Importers Devices
On November 21, 2024, the Vietnam Ministry of Health (MoH) issued Decision No. 3514/QD-BYT, officially abolishing Decision No. 5086/QD-BYT and Decision No. 2807/QD-BYT. These decisions previously governed the list of manufacturer’s codes and the encoding of medical supplies for health insurance and healthcare expenses. Updated Guidelines for Medical Supplies Codes The new decision introduces the
Vietnam: MoH Abolishes Regulations on Manufacturer’s Codes and Medical Supplies Encoding Read More »
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 Circular 14/2018/TT-BYT, dated May 15,
Vietnam: MoH Promulgates List of Medical Devices with Assigned Harmonized System Codes Read More »
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 under Section 4 of the
Thailand: Clarification on Vehicles and Medical Equipment Products as Medical Devices Read More »
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 https://regalkes.kemkes.go.id will be temporarily closed
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 of regulating health products, establishments,
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, repackers, refurbishers, and traders), and
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 following updates for stakeholders and
The Thai Food and Drug Administration (FDA) has officially announced the rates for expenses related to monitoring, auditing, and surveillance activities aimed at ensuring compliance with medical device regulations. This new fee structure, effective from November 13 2024, addresses expenses for document evaluation, testing, facility inspections, and related activities to control the manufacturing, importation, and
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