Medical Devices

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

MDA will issue only electronic establishment licenses, affecting medical device manufacturers, importers, and distributors.

Indonesia removes IDAK renewals, mandates SDAK and IPAK transitions, and shortens correction timelines under risk-based licensing.

New MDA guidance introduces a risk-based framework for managing post-registration medical device changes, including software updates and SaMD.

Applicable for new registrations, renewals, and variations, the Standardized Medical Device Specification Template improves data consistency and regulatory review efficiency.

The full implementation of the reliance program creates new opportunities for manufacturers to accelerate regional market entry by strategically leveraging approvals across both jurisdictions.