Medical Device Approval In China: Chinas Regulatory Process For Imported Medica
There are specific processes for imported medical device approval in China. The steps are as follows:
1. Determine the classification of your device using the State Food & Drug Administration (CFDA) classification catalog: Class I Class II Class III
2. Appoint a Legal Agent and After Sales Agent located in China with qualifications
3. Prepare Device Registration Standard according to related China national and industrial standards and specifications of the products
4. Device testing report in CFDA authorized testing center
5. Documentation preparation for Registration
6. Clinical trial reports or articles (if applicable)
7. Applicant need to do clinical trial for long term implantable products in China export whose similar products had registered in CFDA before
8. For other products need to provide overseas clinical report or articles to illustration the efficiency and safety of the products
9. CFDA issues import certificate upon application review. Certificate is valid for 4 years. Place CFDA registration number on device label, packaging and manual.
Notes
Medical devices with a measurement function need to apply to the General Administration of Quality Supervision, Inspection and Quarantine for a measurement certificate and metrological verification.
Quality testing is performed by the CFDA Medical Device Quality Supervision and Inspection Center.
CCC Mark (China Compulsory Certification) is required for several categories of medical devices. A facility audit is required. Normally we can combine CCC tests and CFDA tests together.
For more detailed information of Medical Device Approval in China, please contact us at: +86-10-82608228 or send an e-mail to consult@jtmedical.com
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北京市海淀区苏州街18号长远天地大厦B2座12A08室
010-82608228
consult@jtmedical.com
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