Glucometer CFDA Registration Guideline

The glucometer is regulated as class II medical devices (6840) under CFDA regulations. Foreign manufacturers are required to obtain the imported medical device registration certificate from CFDA for their glucometer product in China. Also on April 6^th 2016, CFDA issued the ‘Technical Guidelines for Glucometer (2016 revised edition)’. Glucometer 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 glucometer described as below can be exempted from clinical trials in China.

Registration Guideline Applicable Objects
Apply to:
This guideline applies to the invasive blood glucose meter. And according to the ‘Medical Device Classification Catalog’ the management code is 6840. The glucometers with movable terminal that transmission through the built-in Bluetooth, WIFI, infrared and etc. are also conformed to this guideline
Not apply to:
Minimally invasive glucometer,
Non-invasive glucose meter,
Continuous glucose meter
Glucose meter that based on the moveable devices with blood glucose testing module
Glucose meter that display and analysis through the data transmission to the moveable devices.

Key Points of Technical Requirement:
1. Product naming requirements
2. Product structure and components
3. Product working principle or mechanism
4. The registration unit principle and examples
Glucometer registration unit partition is subject to product working principle, the structural components, performance index and applicable scope.

Technical structure---If the technical structure is different, the products should be in the different registration units.
Performance index---If the performance index has big difference, the products should be in the different registration units.

5. Product applicable related standards
6. Product applicable scope or intended use, contraindication
7. Product main risk
8. The main performance index that should be included by 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
Product validity and packaging research
Software research

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

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