IVDs

Get answers to common China medical device and IVD registration questions, from NMPA classification rules to testing and renewal requirements.

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.

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

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