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China proposes ICH E6(R3) Annex 2 implementation from January 2027, with public comments open for one month from August 10 2026.
The guideline introduces more detailed evidence requirements for Hong Kong and Macao drug imports while retaining a streamlined pathway for products already approved under the GBA Connect scheme.
TC21-2026-02 introduces stricter chemical limits, enhanced safety requirements, and a 2027 compliance deadline for toys and children’s vehicles.
The revised 2026 GBA Connect Scheme framework sets higher bars for clinical need while fast-tracking repeat approvals for imported medical devices.
TC07 clarifies how companies must convert eligible CCC self-declarations to third-party certification before mandatory compliance deadlines.
The draft clarifies when CDE may issue written supplementary information requests and when major deficiencies identified during review may instead lead to a non-approval conclusion.
Latest Blog Posts
Learn how MARA imported feed registration in China works: Product eligibility, registration requirements, China-based agents, testing and more.
Learn when local testing is required for medical devices and IVDs in Indonesia, which products are affected, and how testing impacts registration requirements.
Learn about NPRA license requirements in Malaysia, including license types, application steps, fees, processing timelines, renewals, and new application requirements.
Understand the key differences between China Medical Device GMP and ISO 13485, including requirements for quality management, suppliers, facilities and documentation.
How to determine medical device classification in Taiwan: the TFDA catalogue, the 16 categories, Class I-III risk levels, and what to do when no item matches.
Learn when medical device and IVD changes in Indonesia require a notification, variation, or new registration, and how to maintain ongoing regulatory compliance.
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
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Join Nick Guo and Zimo Chu from Cisema for a two-day webinar on using MDR clinical data to support China NMPA approval.
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.
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