Insights
Latest News
Updated MDACS guidance creates a new pathway for qualifying technologies and outlines the evidence required for priority consideration.
Explore the latest data on China’s clinical research landscape, including record trial activity, shorter development timelines, and emerging R&D trends.
The 12th national VBP round introduces tighter quality, manufacturing, and IP requirements that pharmaceutical companies must meet to compete.
New NMPA CDE guidelines define CTMP and GTMP boundaries, affecting development strategy, CMC planning, and regulatory engagement in China.
China's updated National Essential Medicines List expands access to innovative medicines, creating new opportunities and strategic considerations for pharmaceutical companies.
China's NMPA expands priority review eligibility for chemical API marketing authorization applications, supporting domestic API production and drug supply.
Latest Blog Posts
Discover the documents required for Indonesia medical device and IVD registration, including dossier requirements, legalization, submission and common FAQs.
A complete guide to China hyaluronic acid registration, covering classification, NMPA requirements, and compliance steps for manufacturers.
Learn how to register medical devices in Indonesia, including Authorized Representative rules, classification, dossiers, timelines, and fees.
Learn how South Korea’s Ministry of Food and Drug Safety regulates medical devices, including classification, application review and post-market duties.
Understand South Korea’s medical device regulations, from classification to approval and post-market compliance.
Learn the latest China NMPA registration fees for imported and domestic drugs and medical devices.
Latest Whitepapers
Learn about regulatory pathways, classification rules, testing requirements, and lifecycle compliance for IVD reagents.
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China Energy Label (CEL) requirements explained. Learn about product categories, energy efficiency testing, labeling rules, and approval procedures for China.
China NMPA drug registration explained. Learn about pharmaceutical approval pathways, regulatory framework, clinical trials, and market authorization for drugs in China.
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Learn how the China Manufacturer License (CML) applies to pressure vessels, boilers, and special equipment approvals.
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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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