Medical Devices

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

Learn how to fast-track medical device registration in ASEAN: timelines, costs, and license options in Malaysia, Singapore, and Vietnam.

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.

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

Learn the Malaysia medical device registration process, covering MDA requirements, classification, CAB assessment, timelines, costs, and Authorised Representative roles.

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

Learn how the medical device markets of Thailand, Indonesia, and the Philippines differ in terms of regulation, healthcare growth, and commercial opportunity.

Gain an overview of the medical device registration process in Vietnam with timelines, fees, and Authorized Representative requirements.

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

A complete guide to China hyaluronic acid registration, covering classification, NMPA requirements, and compliance steps for manufacturers.

Learn about Malaysia’s conformity assessment bodies — including CAB evaluation routes, risk classifications, and MDA registration steps.