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Latest News
Understand the key components of the Malaysia Medical Device Registration Dossier for Class B, C and D device submissions.
HSA now requires CMC validity declarations and accepts eCTD submissions, strengthening therapeutic product registration requirements.
Taiwan's TFDA will reduce clinical trial submission documents and ease decentralized trial requirements for sponsors from July 1, 2026.
New rules strengthen data governance and raise sponsor oversight duties from September 2026.
New rules expand platform accountability and regulatory oversight, reshaping how pharmaceutical products are promoted, sold, and controlled online.
New NMPA packaging size guidance encourages drug applicants to align pack sizes with clinical use, patient needs, and sustainability goals.
Latest Blog Posts
Understand the key components of the Malaysia Medical Device Registration Dossier for Class B, C and D device submissions.
Identify China medical device GMP gaps and prepare QMS, supplier, data, and inspection controls before NMPA market entry.
Learn how South Korea’s Ministry of Food and Drug Safety regulates medical devices, including classification, application review and post-market duties.
Learn how MFDS’s Digital Medical Product Safety Management Roadmap will shape future compliance requirements for digital medical products in Korea.
Understand South Korea’s medical device regulations, from classification to approval and post-market compliance.
Learn how South Korea medical device classification works under the MFDS.
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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