Dental Planter CFDA Registration Unit Division

Medical devices in the disparate registration units have to obtain different CFDA Registration Certificates. And dental planter consists of so many different parts that the manufactures might be curious about the amount of the registration units for the dental planter.

Specialized term explanation:
Dental handset: It is a hand holding tools to transmit (convert or unconverted) operation energy required for the dental instruments or appliances.

The Key Points for the Dental Planter Registration Unit Division.

Based on structural difference, these dental planters will be divided into different registration units. There are three types of power supply: built-in, grid power supply and internal power supply so these three types of power supply will be divided into three different registration units.
The water supply pipe and implant surgical instruments cannot be included in the dental planter registration unit.
If the interface of the dental planter handset is conformed to the wildcard interface in the YY 1012 (ISO 3964), CFDA suggest to declare the handset as a separate registered unit.
If the motor and handset are included in the dental planter registration unit, these motor and handset should be exclusive for the same registration unit dental planter.
For the dental handset with lighting feature and without light feature, they should be in the different registration units.

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

Related links:

Active Medical Devices CFDA Registration Units Partition

Dental Planter Registration Guideline

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