IVDs

The new documents clarify expectations for Tier III variants, companion diagnostic clinical evaluation, tissue and plasma registration, and HLA-B*58:01 analytical validation.

New WHO CRP pathway enables faster MDA review of eligible WHO-prequalified IVDs.

New policy streamlines COVID-19 Antigen RDT registration and renewal applications.

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.