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Manufacturers seeking MRI registration in China must meet expanded technical, software, and validation requirements.
The new documents clarify expectations for Tier III variants, companion diagnostic clinical evaluation, tissue and plasma registration, and HLA-B*58:01 analytical validation.
As of July 1, 2026, Taiwan has completed its cosmetic GMP rollout, extending mandatory ISO 22716-based manufacturing standards to nearly all cosmetic factories
New NCI rules reduce administrative burden, streamline dossiers, and expand opportunities to reuse existing safety data.
Review China's new draft standards for cosmetic cheilitis and contact urticaria before the August 15, 2026, consultation deadline.
China's new BCI medical device guidance establishes classification and naming principles, giving manufacturers a clearer pathway to NMPA registration.
Latest Blog Posts
Learn the key requirements for China food labeling compliance: mandatory label content, ingredient declarations, imported food requirements, and more.
Learn Indonesia's cosmetic PIF requirements, ingredient compliance rules, and common pitfalls to avoid.
Learn how China IVD risk classification works under NMPA rules and see common compliance pitfalls to avoid.
Understand South Korea’s medical device regulations, from classification to approval and post-market compliance.
Learn how MFDS’s Digital Medical Product Safety Management Roadmap will shape future compliance requirements for digital medical products in Korea.
Learn how South Korea’s Ministry of Food and Drug Safety regulates medical devices, including classification, application review and post-market duties.
Latest Whitepapers
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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.
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Latest Webinars
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.
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