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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.
The R&D import whitelist scheme streamlines customs clearance while maintaining specific eligibility, traceability, and risk-control requirements.
The new edition covers license applications, processing times, renewals, and licensing changes for registered products in Malaysia.
Taiwan’s TFDA released its updated 2026 recognized medical device standards list to harmonize regulations and streamline global market access.
Taiwan TFDA requires license holders of semaglutide and tirzepatide-containing drugsto submit risk assessment and control plans within three months.
Learn the proposed changes to China’s drug traceability system requirements and the key considerations for industry stakeholders.
Latest Blog Posts
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.
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Gain an overview of the medical device registration process in Vietnam with timelines, fees, and Authorized Representative requirements.
Explore the medical device market opportunities, regulations, and registration pathways across Malaysia, Singapore, Vietnam, and other key ASEAN countries.
Discover how leveraging Real World Data generated in the Greater Bay Area can accelerate market entry for medical products in China.
Learn about China's Unique Device Identification (UDI) system and how to navigate China’s evolving medical device market.
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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