Medical Devices

Learn how to prepare a compliant dossier for Vietnam medical device registration in this guide for foreign manufacturers.

Track all imported Class II and III medical device approvals in China with this monthly updated NMPA submission tracker.

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

Learn which products are covered by Indonesia's halal framework, the labeling and manufacturing obligations, and phased compliance timelines.

Practical China medical device glossary explaining NMPA terms, with clear comparisons to US FDA and EU MDR terminology.

Learn how to register medical devices in Indonesia, including Authorized Representative rules, classification, dossiers, timelines, and fees.

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.

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

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

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.