The Medical Device Authority (MDA) has announced the approval of a minor amendment to Circular Letter No. 1 Year 2025. The revised document is now designated as Circular Letter No. 2 Year 2025 (“the Circular”) and took effect on 30 September 2025. Scope Summary of the latest update issued
The Medical Device Authority (MDA) has released the draft Seventh Edition of the Guidance Document titled “Requirements for Labelling of Medical Devices” for public consultation. The draft introduces key amendments to the existing labelling framework, including the proposed implementation of electronic labelling (e-labelling) for home-use medical devices, aligning Malaysia’s regulatory
The Medical Device Authority (MDA) has published the draft First Edition Guidance Document (PDF) titled “Application for Confirmation Status of Obsolete and Discontinued Medical Device” for public comment. The guidance outlines the eligibility criteria, application procedures, and the responsibilities and obligations of establishments in managing obsolete and discontinued medical devices.
The Health Sciences Authority (HSA) and the Singapore Manufacturing Federation (SMF), through its Medical Technology Industry Group (MTIG), have launched an integrated regulatory support ecosystem for Singapore’s MedTech sector. This collaboration combines the SME Centre@SMF’s business advisory services with HSA’s Health Products Regulation Group (HPRG) Innovation Office to shift regulatory
The Food and Drug Administration (FDA) of the Philippines has released a draft Circular titled “Guidelines on the Inspection of Medical Device Establishments” to enhance regulatory oversight and ensure continued compliance with safety and quality standards. This establishes uniform inspection procedures, documentary requirements, and evaluation criteria for manufacturers, traders, distributors,
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,
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