Classification of Medical Devices in China

If the intended use of your product is ambiguous, particularly regarding medical applications, it might be classified in a grey area. For further clarification, please refer to my previous post titled “Is my product considered a medical device in China?”

Do you know that the web version of the old classification catalog is accessible to the public? NMPA reviews and adjusts the list of products every year, but the changes are not fully reflected on the web version. Nevertheless, it serves as a good reference to understand your product classification with the help of Google Translate plugin. Following is the list of guidance that you can refer to regarding the classification of medical devices.

• Old medical device classification catalog (Public version) https://www.nmpa.gov.cn/wwwroot/gyx02302/flml.htm)

• Classification rules of medical devices (No. 15 of 2015)

• Medical device classification catalog (No. 104 of 2017)

• Product catalog of Class I medical device (No. 158 of 2021）

• Notice on the adjustment of medical device classification catalog (No. 25 and No. 30 of 2022, No. 101 of 2023)

Product code and determine risk class in China

The current classification catalog of NMPA consists of 22 categories of medical devices in comparison to the previous 43 groups. The old classification code is 5 digits (e.g. 6821-1), while the new classification code comprises the main catalog group, primary and secondary product classification categories (e.g. 08-03-04). It is useful to keep your product’s classification code in mind, as it allows you to judge whether a guidance document applies to your product.

Based on the unceasing innovations and development of medical technologies, NMPA regularly revises the existing product list to follow the state-of-art and best practices of the medical device industry. For instance, NMPA has been incorporating AI-based medical solutions by developing relevant guidance on product classification and applicable standards, as well as establishing technical units and expert panels.

China’s Risk Classification In Comparison with Other Countries

• EU

Unlike EU MDD or MDR, risk classification in China is much more simplified, as Class I is not subdivided into Class Is [sterile], Im [measuring], and Ir [reusable]).

Hence, single-use and sterile medical devices are usually classified as Class II or Class III based on device characteristics (active/ non-active), contact of the human body, and the duration of use, invasiveness, or the intended effects. Reusable and measuring medical devices can be either class, depending on its intended purpose, indications of use and potential risks to the patient.

Unlike China, Class Is, Im, Ir, Class IIa manufacturers and above are subject to conformity assessment procedures set out in Annexes IX to XI of Regulation (EU) 2017/745 in the EU with the appropriate involvement of an independent notified body. As for class I devices, the conformity assessment procedure should be carried out under the sole responsibility of manufacturers after drawing up the technical documentation. This is not the case in China, where notification or submission to the regional or national health authority is compulsory for all medical devices in China.

Identifying the risk class of medical devices in China is more straightforward, as the product catalog provides a distinctive explanation of the product description, intended purpose, and some examples of the products.

• USA

Identification of the appropriate classification regulation for your device is essential to understand the risk class and whether any exemptions may exist. If your product falls in the scope of Class I or II’s exemption list, a 510(k) premarket notification will not be required. On the contrary, the notification or registration of medical devices is compulsory for all risk classes of medical devices in China. There is no such exemption implemented by NMPA in China. Nevertheless, the listing of the device identifiers on the GUDID database, as well as FURLS establishment registration is still needed for the US. Notification of Unique Device Identification (UDI) to UDI system has become compulsory in China since October 1st, 2019.

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Disclaimer: 

This content is created solely in my personal interest and do not reflect the views, opinions, or policies of my employer or any other organizations I am affiliated with. The information provided is for informational purposes only and should not be construed as professional advice. Neither I nor my employer is liable for any use of this content. This newsletter is non-commercial and does not compete with my employer’s interests. Any references to regulatory updates or guidance are based on publicly available information and are not intended to infringe upon proprietary or confidential content.