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Daohoo  (Beijing) Technology  CO., LTD.

 Class II III medical devices registration

  • PRODUCT DETAIL


1.Chinese specification drafting (dossier preparation and specification drafting)
Timeframe: about 1 month
2.Sample testing
Timeframe: about 6 months
3.Filing to the CFDA (CFDA preliminary review and acceptance notice)
Timeframe: 1 month
4.CMDE review; CMDE will issue a supplementary notice
Timeframe: 60-90 working days.
5.Supplementary dossier preparation
Timeframe: maximum 1 year
6.Further CMDE review
Timeframe: 60 working days
7.CFDA final review and granting of the registration approval
Timeframe: 30 working days
Also note that clinical trials may be required for certain high-risk devices (e.g. implantable devices).

Class II & Class III Device
A total of 12 document items must be collected and submitted to the CFDA, consisting of 9 legal documents, 2 technical documents, and a testing report issued by a CFDA certified testing center:
1.Application Form
2.Legal Documents
3.Main Safety and Efficacy Specifications List
4.Summary Data
(1)Overview
(2)Product description
(3)Product model
(4)Description of the package
(5)Intended use and contraindications
(6)Predicated device (if applicable).
(7)Other information
5.Research Data
(1)Product performance evaluation data
(2)Biocompatibility evaluation data
(3)Biosafety research data
(4)Sterilization and disinfection process validation data
(5)Shelf and package evaluation data
(6)Animal research data
(7)Software validation data
(8)Other data if necessary
6Manufacturing information
(1)Manufacturing process description for active/inactive device
(2)Manufacturing site description
7.Clinical Evaluation Data
8.Product Risk Analysis Data
9.Product Technical Specifications
10.Registration Testing Report
(1)Testing report issued by a CFDA certified lab
(2)Preliminary evaluation comment from the testing lab
11.Artwork for the IFU and Product Label
(1)Instructions for use (IFU)
(2)Artwork of the product label for the minimum selling unit
12.Self-declaration Documents