2025-11-26
This article summarizes key insights from Qualtech's 2025 ASEAN regulatory webinar, highlighting major updates in Indonesia, Thailand and Vietnam. The recap covers changes in retail rules, procurement, halal enforcement, reliance pathways and registration procedures, reflecting how these markets are streamlining medical device approvals and improving regional market access.
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2025-11-26
On 2 October 2025, the Singapore Health Sciences Authority (HSA) conducted the Health Products Regulatory Conference 2025, which was held jointly with the Singapore Manufacturing Federation (SMF) MedTech Day. The event elevated the theme: "Advancing Singapore's Medtech Ecosystem: be connected, collaborative, and future-ready".
During the conference, the HSA's Medical Device Cluster (MDC) shared insights on the evolving regulatory landscape, examining both present developments and anticipated future trends in the field, especially related to digital health products.
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2025-11-21
The Malaysian Medical Device Authority (MDA) has issued the Medical Device (Amendment) Regulations 2025 [P.U.(A) 330], which were gazetted on 11 September 2025. This amendment revises the fee structure for registrations of Class A medical device effective on or after 1 January 2026. Stakeholders are advised to review the changes and plan their submissions accordingly to ensure timely compliance.
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