Insights

China’s NIFDC releases 6 new technical guidelines for high-risk cosmetics, impacting hair dye, perming, and sunscreen product compliance.

Hong Kong introduces Primary Evaluation Phase 1 for NDAs, requiring pathway selection across 3 routes and reshaping drug registration strategy.

Hong Kong confirms injectable products are generally classified as pharmaceutical products under Cap. 138, impacting medical aesthetics and borderline products

The reforms introduce new drug pricing rules, clarified conditional approval procedures, and tiered care measures.

TFDA eliminates legacy cosmetics review fees, reducing compliance costs for foreign companies.

CMDE maps 275 guideline updates, tightening requirements and giving manufacturers early visibility for planning and compliance.

Learn how the China Manufacturer License (CML) applies to pressure vessels, boilers, and special equipment approvals.

Explore China’s product safety certification system, testing requirements, certification procedures, and compliance obligations.

Understand SAMR's filing and registration pathways, regulatory requirements, testing obligations, and compliance rules for health foods and supplements.

Learn about NMPA regulations, CSAR requirements, product testing, labeling rules, and approval pathways for cosmetics.

Plan your medical device or SaMD expansion in Southeast Asia with practical guidance on ASEAN regulations, market entry pathways, timelines, and approval strategies.

Join Cisema’s experts, Hamish King and Jacky Li, for a free webinar that unpacks the essentials of China NMPA medical device registration.

Join a free webinar on China’s MedTech market, regulations, and fast-track pathways during the UK’s International Trade Week 2025.

Watch the on-demand webinar with Hamish King and Victoria Caldy covering key China medical device regulatory updates from 2024, approval trends, the new draft law, GBA fast-track pathways, and compliance considerations for 2025.