Surgical Astral Lamp Registration Guideline

On March 28^th 2017, Center for Medical Device Evaluation (CMDE) issued ‘Technical Examination Guidelines for the Surgical Astral Lamp (2017 the 30^th)’

CFDA Clinical Trial Exemption
According to the “Catalog of Class II Medical Devices Exempted from Clinical Trials” (first batch 21st Aug. 2014), the Surgical Astral Lamp described as below can be exempted from clinical trials in China.

Registration Guideline Applicable Objects:

Apply to:
This guideline applies to the class II Surgical Astral Lamp. Surgical Astral Lamp (The code in the ‘Medical Device Classification catalog’ is 6854-13.1) is providing visible light for the operation field or patients during the operation process.

Classification Category	Type
Setup difference	Stationary type Moveable type
Optics principles difference	Overall reflection type Multisource reflection type Prism refraction type
Light source difference	Halogen lamp Xenon lamp LED(luminous diode) lamp

Not apply to: Operation illuminating lamp, operation reflector lamp (The code in the ‘Medical Device Classification catalog’ is 6854-13.2) and diagnostic lighting.

Key Points of Technical Requirements:
1. Product naming requirements
2. Product structure and components
3. Product working principle or mechanism
4. The registration unit principle and examples
The registration unit division is based on the comprehensive consideration of the product’s intended use, performance index and technological structure.
Ex:

Technological structure difference for the different registration units, such as moveable Surgical Astral Lamp and stationary Surgical Astral Lamp will be in the different registration units.
Electrical protection types difference for the different registration units.
…

5. Product applicable related standards
6. Product applicable scope or intended use, contraindication
7. Product main risk and research requirements
1. Product main risk
2. Research requirements

Product performance research
Biosafety research
Biocompatibility evaluation
Sterilization process research
Product life-span
Packaging research
Software research

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.
12. Product adverse events record
13. Product specification and label requirements

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

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