What are the common Class I Medical Devices in China?
The classification in China is not the same as in Europe and the US. Often, a class I device in Europe and the US is regulated in higher classes in China.
There are some general excluding criteria for Class I device:
- Any active device with human body contact is NOT a class I device.
- Any sterile device is NOT a class I device.
- Any software as a medical device (SaMD) is NOT a class I device.
There are some general including criteria for Class I device:
- Reusable surgical instrument transiently used on the skin, cavity or tissue are Class I medical devices.
- Non-sterile dressings transiently used on the skin, cavity or tissue are Class I medical devices.
To check whether a device is Class I, the manufacturer can reference the current Category List or the predicates in the database of NMPA website (only available in Chinese).
How is the Class I notification to be done in China?
The imported device must be registered in the home country.
The manufacturer shall have a Chinese company or a rep office in China to act as a China agent to communicate with the NMPA. You may use the legal representative service of JMEDTEC in China, if needed.
Ensure the device is class I by using the reference in the Category List or the result of classification determination process.
The following dossier is required for class I notification:
- Application form
- Safety and risk analysis report
- Product technical requirements
- Product testing report (it can be an in-house testing report. The involvement of a third-party report is not necessary)
- Clinical evaluation report
- IFU and draft of label for the minimum sale unit
- Information about manufacturing process
- Business license, the device approval in the home country approval, authorization letter of the China agent
- Declaration of conformity (NMPA format)
The dossier must be provided in both English (or the official language in the home country) and translated in Chinese. The dossier shall be notarized in the home country.
The notification of class I device does not involve the technical review. The administrative office of NMPA shall check the content and the format of the dossier. In case of any incompliance, the dossier is returned to the manufacturer with comments. If everyone is acceptable, the NMPA shall release a notification letter immediately to the China agent.
No fee is charged by the NMPA in this process.
The main challenges of the process is that the device does not fit into any existing item in the Category List. The administrative office of the NMPA may reject the submission in this case. The manufacturer shall evaluate the product description and the intended use of the device to approach the description of the existing item as much as possible.
Another common challenge is to divide the registration units correctly. It is understandable that the manufacturer wants to apply as few registration units as possible to lower the cost and efforts. However, including all the configurations in a single unit would lead to the unnecessary rejection as well. The manufacturer shall ensure the configurations of devices are divided into correct registration units.
Why choose JMEDTEC to assist you with the Class I notification?
JMedTec has the professional team to identify the optimal strategy for justifying the product information according to the regulations and combining the configuration to save the costs and efforts for the manufacturer.
For example, we have managed to adapt the local intended use of the device with a trade-off between the regulation requirements and the marketing strategy of the manufacturer for a success notification with limited costs.
Please contact us for further help at firstname.lastname@example.org.