Blog Posts

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.

Understand the key differences between China Medical Device GMP and ISO 13485, including requirements for quality management, suppliers, facilities and documentation.

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.

Learn when medical device and IVD changes in Indonesia require a notification, variation, or new registration, and how to maintain ongoing regulatory compliance.

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.

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

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

Learn how overseas cosmetic manufacturers can meet Indonesia’s BPOM notification requirements and legally bring their products to market.

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.

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.