IVDs

Summary of 2025 MFDS trends covering medical device approvals, import dynamics, and the shift toward AI and software-based regulation.

China’s National Medical Products Administration has issued its 2026 medical device standards plan, introducing 80+ new and revised standards

Learn about the 104 products China’s NMPA admitted into the Special Review Procedure for Innovative Medical Devices in 2025.

Hong Kong’s Department of Health introduces Pre-NDA meetings to streamline new drug registrations under the “1+” mechanism.

The Department of Health has mandated MDACS listing for public procurement eligibility — see which devices are affected and how to prepare.

China’s H1 medical device imports reached approx. USD 24 billion, showing stable demand amid shifts in key categories and sourcing countries.

NMPA issues draft changes to China’s IVD Classification Catalogue, adding new risk classes and technology platforms.

Indonesia revises medical device and IVD registration timelines under Permenkes 11/2025, extending approval timelines.

Malaysia MDA's Draft 7th Edition labelling requirements introduce broader e-labelling requirements and stronger accessibility standards.

Latest NMPA drafts propose expanding Unique Device Identification (UDI) rules to nearly all medical devices by 2029.

NMPA’s draft guide defines medical device registration self-testing and self-checking for Class II and III devices under China’s QMS rules.

Malaysia and China launch a regulatory reliance pilot to streamline IVD medical device registration and accelerate cross-border market access.