Medical Devices

The revised 2026 GBA Connect Scheme framework sets higher bars for clinical need while fast-tracking repeat approvals for imported medical devices.

Taiwan’s TFDA released its updated 2026 recognized medical device standards list to harmonize regulations and streamline global market access.

Overseas medical device manufacturers must prepare for Malaysia MDA's new hologram labeling framework designed to curb counterfeits and secure supply chains.

Understand what China’s revised medical device GMP means for quality management and digital compliance, alongside changes to classification, emerging technologies, and online sales.

By shifting the focus beyond lowest-price bidding, the new policy rewards innovation, clinical performance, and long-term value in public hospital procurement.

Updated MDACS guidance creates a new pathway for qualifying technologies and outlines the evidence required for priority consideration.

MIIT expands China's RoHS product scope, adds four restricted substances, and introduces new exemptions with compliance deadlines from August 2027.

Learn how Vietnam's Ministry of Health is implementing risk-based product quality management under Decree No. 37/2026/ND-CP and what it means for regulated businesses.

The ten Good Machine Learning Practice principles covering the design, development, validation, use, and post-market management of AI medical devices.

Manufacturers seeking MRI registration in China must meet expanded technical, software, and validation requirements.

China's new BCI medical device guidance establishes classification and naming principles, giving manufacturers a clearer pathway to NMPA registration.

New Hainan MPA guidance clarifies how Lecheng real-world evidence can support imported product registration, labeling updates, and post-approval activities