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 »
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
On November 19, 2024, the Infrastructure and Medical Device Administration (IMDA) issued Letter No. 519/HHTB-DKKD, requesting enterprises to provide details about class C and class D medical devices with import licenses that were set to expire on December 31, 2024. The IMDA sought this information to synthesize, report, and propose solutions to the Ministry of
Malaysia’s Medical Device Authority (MDA) has issued a draft guidance document for the first edition of Control of Obsolete and Discontinued Medical Devices in Healthcare or Related Facilities. This article provides guidelines on managing medical devices that are obsolete or discontinued to ensure uninterrupted healthcare operations. Obsolete Devices The manufacturer must officially declare a device
Malaysia: Managing Obsolete and Discontinued Medical Devices in Healthcare Facilities Read More »
The Ministry of Health (MOH) in Vietnam issued Circular 29/2024/TT-BYT on November 3, 2024, mandating the price declaration of certain medical devices based on their technical and economic characteristics. This circular specifies the requirements for declaring prices, including the product name and specific model, and will take effect on January 1, 2025: Specific model Detailed
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On October 30, 2024, the Deputy for Digital Procurement Transformation at Indonesia’s National Public Procurement Agency (LKPP) issued a decision to deactivate the Electronic Catalogue Version 5, aimed at streamlining the e-Catalogue business process. Key Conditions for Deactivation: Key Conditions for Deactivation: Deactivation of Product Showcase Creation for Local/Sectoral e-Catalogue: Effective immediately, the feature to
Indonesia: Deactivation of the Electronic Catalogue System Version 5 Read More »
The Thai Food and Drug Administration (FDA) has issued a draft announcement detailing the criteria, methods, and conditions for requesting, issuing, and managing licenses for medical device advertising. This new draft aims to regulate and control medical device advertisements to ensure accurate, ethical, and culturally appropriate messaging. Key Highlights of the Draft Announcement: Revocation of
Thailand: Draft Announcement on Medical Device Advertising Licenses by the Thai FDA Read More »
On October 10, 2024, Indonesia’s Ministry of Health (MoH) announced the opening of an International Tender Procurement for a project named Strengthening Indonesia’s Healthcare Referral Network (SIHREN). The official announcement is available on the e-Catalogue website in both Indonesian and English. You can access it here. Further details about the procurement process are available in
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Regulatory updates, Vietnam On October 4, 2024, the Ministry of Health (MoH) of Vietnam issued three notices—Notice No. 6065/BYT-HTTB to the Department of Health (DoH), Notice No. 6066/BYT-HTTB to medical device manufacturers, and Notice No. 6067/BYT-HTTB to traders, exporters, and importers—calling for a survey of the current situation and gathering feedback on the draft of
Vietnam: Survey and Gathering Feedback for the Draft of Medical Device Law Read More »
Regulatory updates, Thailand On October 11, 2024, the Thai Food and Drug Administration (FDA) published new guidelines on labeling requirements for medical devices. These guidelines provide clarity on how labels should be attached to medical devices intended for both home use and professional use. The key points of the guidelines are as follows: 1. Labeling
Thailand: Guidelines for Attaching Medical Device Labels Read More »
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