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Latest News
New requirements could affect how injectable devices, including dermal fillers, are supplied in Hong Kong’s private healthcare sector.
China’s new Healthcare Security Law affects medical device reimbursement, health economic evidence, payment models, and digital traceability from 2027.
BPJPH Regulation No. 4 of 2026 introduces pre-shipment halal verification and LPPH reports for imported goods starting September 2026.
New CVDA guidelines provide detailed guidance for online veterinary drug sellers and platforms, covering licensing, imports, labeling, prescriptions, and traceability.
China’s NMPA has released YY/T 2029–2026, establishing the world's first AI-BCI EEG dataset quality standard for medical devices ahead of its September 2027 enforcement.
China's NMPA has established two supplementary testing methods to detect prohibited substances in cosmetics with high-sensitivity liquid chromatography.
Latest Blog Posts
Understand the key differences between China Medical Device GMP and ISO 13485, including requirements for quality management, suppliers, facilities and documentation.
Learn about China's Unique Device Identification (UDI) system and how to navigate China’s evolving medical device market.
Discover how leveraging Real World Data generated in the Greater Bay Area can accelerate market entry for medical products in China.
Learn when medical device and IVD changes in Indonesia require a notification, variation, or new registration, and how to maintain ongoing regulatory compliance.
This guide explains Singapore’s HSA regulatory system and why it is a strategic first step for entering Southeast Asian markets with medical devices, pharmaceuticals, and cosmetics.
Track all imported Class II and III medical device approvals in China with this monthly updated NMPA submission tracker.
Latest Whitepapers
Understand the China NMPA medical device approval processes, regulatory pathways, and clinical requirements.
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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.
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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.
Cisema’s Stefanie Fasshauer shared insights into recent NMPA reforms, drug registration, compliance requirements, and emerging trends shaping China’s pharmaceutical landscape.
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.
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