Medical Devices

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

Learn the latest China NMPA registration fees for imported and domestic drugs and medical devices.

Discover the documents required for Indonesia medical device and IVD registration, including dossier requirements, legalization, submission and common FAQs.

Learn about license validity and renewal rules for medical devices in Southeast Asia.

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

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

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.

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

Understand the key components of the Malaysia Medical Device Registration Dossier for Class B, C and D device submissions.

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