Medical Nebulizer Registration Guideline

The Medical Nebulizer are regulated as class II medical devices (6821) under CFDA regulations. Foreign manufacturers are required to obtain the imported medical device registration certificate from CFDA for their medical Nebulizer product in China. Also CFDA issued the “Technical Guidelines for Medical Nebulizer (2016 revised edition)”. Medical Nebulizer CFDA registration should be conformed to this guidelines.

CFDA Clinical Trial Exemption
According to the “Catalog of Class II Medical Devices Exempted from Clinical Trials” (first batch 21^st 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 231^st). 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

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

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