Medical Devices

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

Learn how China regulates SaMD, including NMPA risk classification, registration, clinical evaluation, cybersecurity, AI, and software changes.

Find out when a clinical trial is required in China and when clinical evaluation, exemptions, overseas data, or other evidence may be sufficient.

Understand Indonesia’s foreign halal certificate requirements, including covered categories and BPJPH registration routes.

Learn when local testing is required for medical devices and IVDs in Indonesia, which products are affected, and how testing impacts registration requirements.

How to determine medical device classification in Taiwan: the TFDA catalogue, the 16 categories, Class I-III risk levels, and what to do when no item matches.

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

Explore the medical device market opportunities, regulations, and registration pathways across Malaysia, Singapore, Vietnam, and other key ASEAN countries.

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

Understand South Korea’s medical device regulations, from classification to approval and post-market compliance.

Learn how MFDS’s Digital Medical Product Safety Management Roadmap will shape future compliance requirements for digital medical products in Korea.

Learn how South Korea’s Ministry of Food and Drug Safety regulates medical devices, including classification, application review and post-market duties.