Product Description

China State Food and Drug Administration (SFDA) is the legal responsible unit in the Chinese government for medical device approval. All medical devices sold in China must be registered in SFDA before introduced on the Chinese market. SFDA Medical Device Import Registration Certificates (MDIRC) must be renewed every four years

Jiushun will assist global companies in obtaining more State Food & Drug Administration (SFDA) approvals for medical devices or IVD.

Let Jiushun help you with following China medical device regulatory issues:

• Determine device classifications.
• Investigate and evaluate the best route to SFDA approval in China.
• Development of a Product Registration Standards and Technical files.
• Follow Up Whole Testing Procedures.
• Develop clinical protocols and coordinate clinical trials, if required.
• Translate documents and labeling.
• Handle incident reporting, SFDA inspections and device registration renewals.
• Caretaker for all your registration information and documentation.