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How to Compile Clinical Evaluation for Medical Nebulizer CFDA Registration

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According to the 'Catalog of Class II Medical Devices Exempted from Clinical Trials' (first batch 21st Aug. 2014), the Medical Nebulizer described in the “Technical Guidelines for Medical Nebulizer (2016 revised edition)” can be exempted from clinical trials in China. Applicants are required to submit the clinical evaluation documents for the CFDA registration.

The clinical evaluation of Medical Nebulizer should be subject to ‘Medical Device Clinical Evaluation Technical Guideline’ (CFDA 12th Notification attachment, 2014).

The Requirements of the Medical Nebulizer Clinical Evaluation Compiling.
1. Submit the comparison documents of the declared product related information and the product description in the ‘Catalog of Class II Medical Devices Exempted from Clinical Trials’. The comparison content should explain the declared products belongs to the products in ‘Catalog of Class II Medical Devices Exempted from Clinical Trials’.

2. Submit the comparison explanation about the declared products and the similar listed products included in the ‘Catalog of Class II Medical Devices Exempted from Clinical Trials’. The comparison explanation should include ‘The Comparison Chart of the Declared Products and The Similar Listed Products Included in the ‘Catalog of Class II Medical Devices Exempted from Clinical Trials’ and related supporting documents.

The Comparison Chart of the Declared Products and the Similar Listed Products Included in the ‘Catalog of Class II Medical Devices Exempted from Clinical Trials’

Comparison ItemsSimilar Listed Products(in China)Declared ProductsDifferencesOverview of Supporting Documents
Basic principles (working principle/action mechanism)
Structural composition
The skin contacting manufacturing materials
Performance requirement
Sterilization or sterilization
Applicable scope
Usage
Others (add comparison items based on the actual situation)…

How to Certify the Equality
  • The submitted documents shall be able to certify that the declared products have equality with the products described in the ‘Catalog of Class II Medical Devices Exempted from Clinical Trials’.
  • If the declared products have any differences in the structural composition, performance requirements, manufacturing materials, applicable scope and etc. the applicants should explain the differences in details. And also submit the proofing documents to explain that the differences will not affect the equality. At the same time, applicants should explain the differences will not have new risk on the product safety and effectiveness. If the differences might have risk on the product safety and effectiveness, the applicants should supplement the clinical evaluation documents and clinical trials documents based on the risk level.

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* If you have any comments or questions, please contact us at md@cirs-group.com.

  

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Contact Us
+86 571 8720 6559 （GMT+8 8:30~17:00）
md@cirs-group.com