The Medical Device Authority (MDA) of Malaysia has officially gazetted the Medical Device (Amendment) Regulations 2025 [P.U. (A) 330] on September 11, 2025. This amendment revises the fee structure under the Fifth Schedule of the Medical Device Regulations 2012 [P.U. (A) 500/2012] for the registration of Class A medical devices, effective January 1, 2026. To […]
Malaysia: Update on Fees for Class A Medical Devices Read More »
The Medical Device Authority (MDA) of Malaysia announced that Malaysia has been officially recognized as an Affiliate Member of the Medical Device Single Audit Program (MDSAP) by the MDSAP Regulatory Authority Council (RAC), effective September 16, 2025. This milestone aligns Malaysia with other participating regulatory authorities and strengthens its position in the global medical device
On September 30, 2025, the Secretariat General of the Ministry of Health of Indonesia issued a new Notification Letter titled “Deactivation of Electronic Catalogue Version 5”. This update follows the Letter from the Director of Digital Market Procurement LKPP and the Circular Letter from the Head of LKPP Number 2 of 2025 concerning the Deactivation
Indonesia: Deactivation of Electronic Catalogue Version 5 Read More »
On September 19, 2025, the Department of Health (DOH) issued Administrative Order No. 2025-0020, “Rescission of Administrative Order No. 2021-0038 dated June 11, 2021, titled ‘Framework for the Philippine Essential Medical Devices List and Price Reference Index.’” The DOH rescinded the 2021 framework to adopt a more dynamic approach in ensuring the availability of quality
Philippines: Rescission of Administrative Order on Essential Medical Devices Framework Read More »
The Thai FDA has published an infographic and FAQs detailing the renewal process for five types of medical device licenses. The guidance provides step-by-step procedures, timelines, fees, and frequently asked questions to support registrants in maintaining compliance. To view the official announcement: Infographic- กองควบคุมเครื่องมือแพทย์ (Thai FDA Official Website in Thai). FAQs: กองควบคุมเครื่องมือแพทย์ (Thai FDA Official
Thailand: FDA Infographic on Renewal Process and FAQs for Medical Device Licenses Read More »
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