• 2026-06-26 06:03:28

Recent Philippine Food and Drug Administration (PFDA) enforcement actions involving unregistered injectable products highlight the importance of regulatory compliance in the Philippines. This article shares Qualtech's insights on the critical need for strict compliance when expanding into overseas markets, particularly for manufacturers of dermal fillers and other aesthetic injectable products.

• 2026-05-27 10:33:27

On 20 April 2026, Singapore's Health Sciences Authority (HSA) and Japan's Ministry of Health, Labour and Welfare (MHLW) signed a Memorandum of Cooperation (MOC) in Tokyo to enhance bilateral regulatory collaboration. The press release (issued on 21 April 2026) notes that the MOC aims to promote reliance for health products, establish mutual reliance for Good Manufacturing Practice (GMP) inspections, and support information exchange on emerging technologies.

• 2026-01-30 04:16:17

NMPA released the 2025 Catalog of High-End Medical Devices for Priority Approval to expedite the registration process for innovative high-end medical devices.

• 2026-01-30 03:45:43

The NMPA issued revised regulation on the administration of export sales certificates of medical devices, effective May 1, 2026.

• 2025-12-26 03:31:27

The Malaysian Medical Device Authority (MDA) has implemented a Product Classification Letter with a two-years (2) validity in alignment with regulatory requirements. Letters issued before specified dates may expire or require renewal under the updated framework.

• 2025-11-26 06:54:12

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.

• 2025-08-25 07:35:29

The NMPA has released new measures to foster innovation and strengthen regulation of high-end medical devices such as surgical robots, advanced imaging systems, AI medical devices, and innovative biomaterials. The policy emphasizes faster review pathways, improved standards, stronger lifecycle oversight, and enhanced international collaboration, aiming to accelerate market access and boost the global competitiveness of China's medical device industry.

• 2025-07-14 01:44:36

The NMPA issued the Catalog of Medical Devices Exempt from Clinical Evaluation (2025), which took effect on May 12, 2025.

• 2025-07-10 10:02:10

The Malaysia Medical Device Authority (MDA) has published the latest edition of Harmonised Borderline Products in ASEAN which provides an updated classifications list for products that may fall under medical device regulations across ASEAN member states. This update helps establishments to determine their products classification (medical device or non-medical device).

• 2025-07-10 09:14:07

The Health Science Agency (HSA) are pleased to announce the launch of SHARE (Singapore Health Product Access and Regulatory E-System). This new system will replace the existing MEDICS system for medical device product registrations and license submissions.
SHARE was first time introduced to the stakeholders during an Industry Briefing on May 21, 2025. During the session, HSA highlighted key changes implemented for medical devices on SHARE, demonstrated the user interface and key features, and outlined the timeline for the full transition from MEDICS to SHARE, effective July 14, 2025.