Medical Devices

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

Explore fast-track medical device registration in Southeast Asia, cut timelines by 6–12 months, and accelerate market entry with Cisema.

Learn all about HSA medical device registration in Singapore with timelines, fees, and AR requirements in this step-by-step guide.

Learn how South Korea medical device classification works under the MFDS.

Supporting foreign manufacturers entering South Korea with regulatory services for medical devices, IVDs, and quasi-drugs.

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

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

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

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

Identify China medical device GMP gaps and prepare QMS, supplier, data, and inspection controls before NMPA market entry.

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

Learn about China's Unique Device Identification (UDI) system and how to navigate China’s evolving medical device market.