Overview
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.
Entering the Chinese market offers tremendous opportunities for medical device companies, but it is not without risk. Having a partner who understands the opportunities and the competitive environment of the Chinese market is absolutely essential and can be the difference between success and failure.
Jyton assist global companies in obtaining more State Food & Drug Administration (SFDA) approvals for medical devices or IVD than any other consulting firms in China. Our specialists in Beijing work directly with the SFDA on a daily basis, coordinating the submission of regulatory documents, answering SFDA follow up questions and providing insight on how to navigate in the difficult Chinese regulatory landscape.
Find coordinator or assistance in your country by Jyton & Emergo worldwide offices.
Let Jyton help you with the 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.
- Obtain CCC Mark or MOH mark, if required.
- Prepare final submissions and act as official Legal Agent (LA) and After Sales Agent (ASA) in China.
- Handle incident reporting, SFDA inspections and device registration renewals.
- Caretaker for all your registration information and documentation.
China SFDA Approval for Medical Devices
Entering the Chinese market offers tremendous opportunities for medical device companies, but it is not without risk. Having a partner who understands the opportunities and competitive environment of the Chinese market is absolutely essential and can be the difference between success and failure.
Jyton assist global companies in obtaining more State Food & Drug Administration (SFDA) approvals for medical devices or IVD than any other consulting firm in China. Our specialists in Beijing work directly with the SFDA on a daily basis, coordinating the submission of regulatory documents, answering SFDA follow up questions and providing insight on how to navigate in the difficult Chinese regulatory landscape.
Please contact us for more information on obtaining SFDA approval for your medical device in China.
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