Regulatory updates Archives

Philippines: FDA Issues Administrative Order No. 2024-0015 on Updated Regulations for Health Product Establishments

December 12, 2024

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,

Philippines: FDA Concludes Pilot Implementation of eServices Portal for CMDN Applications in NCR

December 12, 2024

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

Thailand: New Fee Structure for Medical Device Monitoring, Auditing, and Surveillance in 2024

December 6, 2024

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

Vietnam: Ministry of Health Requests Information on Medical Devices with Expiring Licenses

November 28, 2024

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: Managing Obsolete and Discontinued Medical Devices in Healthcare Facilities

November 25, 2024

Malaysia’s Medical Device Authority (MDA) has issued a draft guidance document for the first edition of Control of Obsolete and Discontinued Medical Devices in Healthcare or Related Facilities.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

Vietnam: New Circular on Mandatory Price Declaration for Selected Medical Devices

November 18, 2024

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

Regulatory Updates

Philippines: FDA Issues Administrative Order No. 2024-0015 on Updated Regulations for Health Product Establishments

Philippines: FDA Concludes Pilot Implementation of eServices Portal for CMDN Applications in NCR

Thailand: New Fee Structure for Medical Device Monitoring, Auditing, and Surveillance in 2024

Vietnam: Ministry of Health Requests Information on Medical Devices with Expiring Licenses

Malaysia: Managing Obsolete and Discontinued Medical Devices in Healthcare Facilities

Vietnam: New Circular on Mandatory Price Declaration for Selected Medical Devices

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