Dental Curing Light CFDA Registration Guideline

The Dental Curing Light is regulated as class II medical devices (6855) under CFDA regulations. Foreign manufacturers are required to obtain the imported medical device registration certificates from CFDA for their Dental Curing Light products in China. Also on July 29^th 2016, CFDA issued the ‘Technical Guidelines for Dental Curing Light ’(exposure draft ). Dental Curing Light 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 Dental Curing Light described as below can be exempted from clinical trials in China.

Registration Guideline Applicable Objects
Apply to:
This guideline applies to the Dental Curing Light that use quartz tungsten halogen lamp and light emitting diode (LED) as the light sources. The Dental Curing Light functional wavelength should around 385nm-515nm. According to the ‘Medical Device Classification Catalog’ the management code is 6855 and it belongs to oral cavity repair equipment.

Key Points of Technical Requirement:
1. Product naming requirements
2. Product intended use
3. Product describing documents
4. Research documents
5. Registration unit division principle and examples
6. Product production and manufacturing related requirements
7. Product Technical Requirement and problems that need to take consideration during the testing.
8. Product instruction
9. Clinical evaluation documents
10. Others.
* If you have any comments or questions, please contact us at md@cirs-group.com.

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