March 2026

Why Global MedTech Leaders Are Increasing Investment in Asia

Asia is rapidly emerging as a strategic hub for innovation, manufacturing, and commercial expansion in the global MedTech landscape. No longer viewed solely as an end market, the region is becoming a core base where leading companies build capabilities to meet diverse and fast-growing healthcare needs. Insights shared from last year’s LSI USA Emerging MedTech […]

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Vietnam: New Decree on Product and Goods Quality Management Issued

On January 23, 2026, the Vietnamese Government issued Decree No. 37/2026/ND-CP, detailing provisions and measures for the implementation of the Law on Product and Goods Quality. The Decree establishes a comprehensive regulatory framework consisting of 8 chapters and 99 articles governing the quality management of products and goods circulating in Vietnam, with a strong emphasis

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Malaysia: MDA Launches Innovative Medical Device Review Pathway

On March 9, 2026, the Medical Device Authority (MDA), Ministry of Health Malaysia, announced the implementation of the Innovative Medical Device Review Pathway to support the development and regulatory readiness of innovative medical devices in Malaysia. The initiative aligns with the New Industrial Master Plan (NIMP) 2030 and aims to foster collaboration between government, academia,

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Philippines: Administrative Order 2025-0030 Implementing Guidelines for the Post-Marketing Alert System (PMAS) Requirements, Annex 5 of the ASEAN Medical Device Directive (AMDD)

Administrative Order (AO) 2025-0030 was issued by the Philippines Department of Health to formally adopt and implement the Post-Marketing Alert System (PMAS) requirements under Annex 5 of the ASEAN Medical Device Directive (AMDD). The AO establishes the mandatory post-market surveillance framework for medical devices in the Philippines to ensure continued safety, performance and quality following

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Philippines: Designation of Officer of the Day at the Food and Drug Action Center (FDAC)

The Food and Drug Administration (FDA) issued FDA Advisory No. 2026-0274 announcing the designation of an Officer of the Day (OOD) at the Food and Drug Action Center (FDAC). This initiative aims to ensure the continuous, efficient, and timely handling of urgent regulatory concerns, public inquiries, and emergency cases within the Food and Drug Administration

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