CFDA enact the special review and approval procedure for innovative medical device to inspire the research and innovation of medical devices, and to encourage the promotion and application of advanced techniques on medical device. If your product pertains to the innovative medical device, it will make great sense to process your registration in the priority list, that is, it may save you a large number of time.
CFDA defines the innovative medical device as:
- The applicant possesses the core technical patent of the product in China; or the applicant gain the core technical patent of the product via legal transfer procedure; or the application for core technical patent has been published by the China State Council.
- The main operation mechanism of the product has to be initiated in China, the performance index or the safety shall have essential improvement compared to the same kind of products, the technique shall be the international advanced level and own the prominent clinical application value.
- The applicant must have completed the preliminary study and have the basically determined product, the research procedure must be authentic and controlled, the research data must be intact and traceable.
The innovative medical device must meet above requirements simultaneously.
To apply for the special review and approval procedure for innovative medical device, the applicant shall submit following dossiers:
To apply for the special review and approval procedure for innovative medical device, the applicant shall submit following dossiers:
- Application Form
- Business Entity Qualification Certificate of The Applicant
- Intellectual Property of The Product and Proofs
- Overview of The Research Procedure and Consequence of The Product
- Technical Documents of The Product, Including
- Intended use
- Operation mechanism
- Main technical parameters and its determination basis; product standard of main raw materials and key components; main manufacturing process and flow chart; test methods for main performance index.
- Supporting Documents of The Innovation, Including
- Approval report released by patent retrieval institute
- Academic paper or treatise published by core journal to state the clinical application value of the product
- Innovative content and prominent clinical application value of the product
- Analysis and comparison of the same kind product application in domestic markets or abroad markets (if any).
- Security Risk Analysis Report
- Manual Instruction and Label
- Others
If you are a foreign applicant, you shall designate a China agent or your administrative office in China to provide above dossiers. Besides, you shall submit the power of attorney, declaration for authenticity, letter of commitment and business license of the China agent or your administrative office, all the submitted dossiers must be in Chinese.
