CFDA Clinical Trial Exemption
According to the “Catalog of Class II Medical Devices Exempted from Clinical Trials” (first batch 21st Aug. 2014), the Medical Nebulizer described as below can be exempted from clinical trials in China.
Registration Guideline Applicable Objects
Apply to:
This guideline applies to the class II Medical Nebulizer (or Nebulizer).The products atomize medicine for the patients by ultrasonic vibration or gas compressors. This Registration Guideline can applies to two kinds of Medical Nebulizers:
- Ultrasonic Nebulizer with the MD code 6823-6 in the Medical Devices Classification Catalogue.
- Compressing type Nebulizer in ‘The Announcement about 166 Medical devices Classification besides Cold and Hot Dual Control Ablation Needle’ (CFDA 2011, the 231st). The MD code is 6821.
Not apply to:
This guideline cannot apply to mesh nebulizer and external air source used medicine nebulizer (Ex: medicine nebulizer with hospital gas supply system or other compressed medical gas or compressed oxygen gas), but this guideline can be a reference for these devices.
Key Points of Technical Requirement:
1. Product naming requirements
Medical Electronic Thermometers naming should be subject to the ‘Medical Device Naming Principle’, ‘Medical Device Classification Catalog’ and other related standards. The products naming shall mainly base on atomization principle. Ex: ‘Medical Ultrasonic Nebulizer’ or ‘Medical Compressing type Nebulizer’.
2. Product structure and components
3. Product working principle or mechanism
4. The registration unit principle and examples
With the same product working principle, the structural components, performance index and applicable scope are subject to the description listed above. These products can be the same registration unit. If the product technical structure and performance index have difference, they can be different models. Ex: Water proof and non-water proof.
Medical Electronic Thermometers used for the different testing part can be the same registration unit but they should be different models. And it should specify the testing part in the model description.
5. Product applicable related standards
6. Product applicable scope or intended use, contraindication
7. Product main risk
8. The main performance index of the product technical requirements
9. The same registration unit test means these products have certain principles and examples.
10. Product production and manufacturing related requirements
11. Product clinical evaluation detailed requirements.
The clinical evaluation should be subject to ‘Medical Device Clinical Evaluation Technical Guideline’ (CFDA 12th Notification attachment, 2014).
12. Product adverse events record
13. Product specification and label requirements
14. Product research requirements
- Product performance study
- Biocompatibility evaluation study
- Sterilization or disinfection process research
- Product validity and packaging research
- Software research
- Drug compatibility Research
Related links:
- Foreign Medical Device Applicant are Required to Supplement the Chinese Information to CFDA
- Preparation of Medical Device Technical Requirements
- Regulations & Know-how
- Classification and Category of Medical Devices in China
- Free Webinar! CFDA New Notification about Standardize the Use of Chinese Name for Foreign Medical Device CFDA Registration