Insights from Across Asia-Pacific

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 how MARA imported feed registration in China works: Product eligibility, registration requirements, China-based agents, testing and more.

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

Learn about NPRA license requirements in Malaysia, including license types, application steps, fees, processing timelines, renewals, and new application 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 overseas cosmetic manufacturers can meet Indonesia’s BPOM notification requirements and legally bring their products to market.

Learn the key requirements for China food labeling compliance: mandatory label content, ingredient declarations, imported food requirements, and more.

Learn Indonesia's cosmetic PIF requirements, ingredient compliance rules, and common pitfalls to avoid.

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.

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.