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Summary of 2025 MFDS trends covering medical device approvals, import dynamics, and the shift toward AI and software-based regulation.
The updated technical guideline expands regulatory expectations for manufacturing, impurity control, advanced analytics, stability studies, and biosimilar comparability.
China’s NMPA and six government agencies issued new measures that strengthen compliance requirements, anti-bribery controls, and oversight of pharmaceutical promotion activities.
The new framework introduces a distinct regulatory pathway for emerging therapies, with major implications for clinical development and market strategy.
China’s SAMR has released draft advertising review measures that would increase oversight of livestreaming and digital marketing while streamlining certain compliance requirements for regulated products.
The three revised CCC certification standards for low-voltage electrical equipment introduce new testing and compliance requirements.
Latest Blog Posts
Understand MFDS clinical trial requirements for digital medical devices, including real-world evidence, data-based studies, and software validation expectations.
Supporting foreign manufacturers entering South Korea with regulatory services for medical devices, IVDs, and quasi-drugs.
Understand Indonesia halal certification requirements for health supplements, including BPJPH registration, ingredient review, and halal labeling obligations.
Learn which products are covered by Indonesia's halal framework, the labeling and manufacturing obligations, and phased compliance timelines.
Learn how Indonesia halal cosmetic certification works, including BPJPH requirements, halal labeling rules, ingredient compliance, and registration obligations.
Cisema offers regulatory insight and market access strategy for medical devices in Thailand, Indonesia, and the Philippines.
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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