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
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
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
Malaysia’s Medical Device Authority (MDA) has issued a draft guidance document for the first edition of Control of Obsolete and Discontinued Medical Devices in Healthcare or Related Facilities.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
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
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:
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