Registration for MD and IVD reagents in China includes registration test, clinical trial and products registration.
Products registration is the last step.
1. Procedure and time for registration of IVD reagents and MD in CFDA:
1.1 Document accepted: 5 working days
1.2 Evaluation: 60 working days (Class II) 90 working days(Class III)
1.3 Quality system verification (if needed): 30 working days for domestic enterprises, no provisions for foreign
manufacturers (not included in period of evaluation)
1.4 One-time data correction (if needed): 1 year
1.5 Technical review after data correction (if needed): 60 working days
1.6 Administrative approval: 20 working days
1.7 Sending registration certificates: 10 working days
Note: valid period for registration certificate: 5 years.
2. Data list for IVD reagents registration
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Class III
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Class II
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1.Application form
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2.Certificate
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3.Product summarization document
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4.Research data of the main raw materials
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5.Research data of the main production process and reaction system
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6.Evaluation data of the analysis performance
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7.Determination materials of the positive value or reference range
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8. Research data of the stability
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9. Production and self-inspection records
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10. Date for clinical evaluation
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11.Product risk analysis report
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12. Product technical requirements
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13.Product registration test report
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14.Product manual
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15.Sample manuscript of labeling
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16.Statement of conformity
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3. Data list for Medical Devices registration
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Headline
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Secondary Heading
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1. Application form
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2. certification documents
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3. Basic requirements of safe and effective list for medical device
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4. Summary Data
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4.1 Overview
4.2 Product description
4.3 Model and specification
4.4 Package directions
4.5Scope of application and contraindications
4.6 Information of referenced similar products or the former generation products (if any)
4.7 Other contents to be explained
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5. Research Data
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5.1 Product performance study
5.2 Biological compatibility evaluation research
5.3 Biological safety study
5.4 Sterilization/disinfection process research
5.5 Validity and package research
5.6 Animal testing
5.7 Software study
5.8 Other Information
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6. Manufacturing Information
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6.1 Passive /active medical device production process description
6.2 Production site
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7. Clinical Evaluation Materials
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8. Product Risk Analysis Data
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9. Product Technical Requirements
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10. Test Report
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11. Product Specification and Sample Label
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11.1 Product specification
11.2 Sample label of the minimum sales unit
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12. Conformity Declarations
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