Medical Devices

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.

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.

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