Blog Posts

Cisema offers regulatory insight and market access strategy for medical devices in Thailand, Indonesia, and the Philippines.

Explore Vietnam’s fast-track and standard medical device registration pathways and the role of reference approvals in shortening timelines.

Learn 5 key steps for China dental medical device registration, covering classification, biocompatibility testing, and legal agent selection.

Learn how a smart clinical trial strategy for medical devices in China can speed up NMPA approval and bring your product to market faster.

Get answers to common China medical device and IVD registration questions, from NMPA classification rules to testing and renewal requirements.

Learn how China medical device risk classification works under NMPA rules and see common compliance pitfalls to avoid.

Learn how to manage medical device renewals, variations, and change notifications in Vietnam with step-by-step MOH submission guidance.

Discover how leveraging Real World Data generated in the Greater Bay Area can accelerate market entry for medical products in China.

Learn how China IVD risk classification works under NMPA rules and see common compliance pitfalls to avoid.

Gain clarity on often-misunderstood China Manufacture License (CML) requirements, including SELO approval, demo products, and CSEI audits.

Understand the pathway for intraocular lens (IOL) registration in China, including NMPA requirements and key compliance steps.