The CFDA Registration Procedure of Wearable Medical Devices

Wearable medical devices registration procedures have no significant differences from general medical device registration procedure.

CIRS summarized the registration procedure and the key points regarding wearable medical device registration.
I). Classification
1. Check the classification catalog. If your products are not included in the catalog, follow step 2.
2. Apply for the classification determination from National Institutes for Food and Drug Control (NIFDC).
Classification determination is based on product working principle, structural components and intended purpose. The classification will not be changed because the way of products used. However, the products classification might change because the products designed to be a wearable medical devices and working principle, usage mode, product specialty and etc. changed.
Ex: The traditional electronic thermometer and sphygmomanometer belong to 6820 General Examination Equipment. But these products designed to be a wearable product, the intended purpose will be changed because the functions of wearable device are monitor and data is collected continuously. It is therefore, these wearable electronic thermometer and sphygmomanometer will be divided into 6821 Medical Electronic Equipment.

II) Registration Test
After confirming the classification, it is followed with registration test. The registration test application is according to the practical situation of device. In general, manufacturer needs to provide product sample, technical requirement, instruction and label. If the product includes software but the software loading hardware not within the product components, manufacture also need to send the hardware that support software operation. If there is any platform or cell phone or laptop working with the product under the special requirement, these equipment need to do the test as attachment. .
At the same time, manufactures have to commission the test institution to do the biological test for the biocompatibility study, because the long term skin contact of wearable medical device. The detailed test items should refer to GB/T 16886.1-2011. Also this part is subject to commission test.

III) Clinical Evaluation
For the class II and III medical device, they all need to submit clinical evaluation for the registration. According to the requirement in ‘Medical Device Clinical Evaluation Technic Guideline’, manufacture should base on the real situation to choose the clinical evaluation methods:

Apply for the clinical trial exemption.
Acquire the similar medical device clinical data.
Conduct clinical trials.

*Any products that want to apply for the clinical trial exemption have to submit the declared products’ compared explanation with the domestic registered products included in the catalog.

《Comparison Chart of Declared Products and CFDA Registered Products Included in the Catalog》

Comparison Item	Medical devices in the catalog	Declared products	Difference	Summary of supporting data
Rationale (working principle /action mechanism
Structural components
Product Manufacturing materials and skin contact materials
Performance requirements
Sterilization/disinfection　method
Application scope
Usage
……

IV. Registration accreditation and system examination submission
For the registration application, the wearable medical device registration dossiers are not different from other products’. CIRS will share the registration dossiers requirements in the following news.

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