Medical Device Classification & Registration in China – 4 Things You Must Know

Who is responsible for medical device classification and registration in China?

First of all, China’s National Medical Products Administration (NMPA, formally CFDA) is responsible for the regulation of medical devices and drugs in China.

Established in 1998, The CFDA oversaw medical devices, drugs and food (only after 2003). In March 2018, CFDA changed its name to NMPA. Since 2018, NMPA only regulates pharmaceuticals and medical devices.

After the 2018 reorganization, NMPA’s Department of Medical Device Registration manages registration for domestic Class III and imported Class I, Class II and Class III devices (provincial NMPA is responsible for domestic Class I and Class II devices). This department administers classification and ensures that control procedures are optimized. It is also responsible for ensuring that good manufacturing practices (GMPs) are implemented.

NMPA’s Department of Medical Device Supervision is responsible for any issues that arise during the manufacturing process. This department evaluates problems with medical devices and monitors adverse events. They also reevaluate the product after the event is reported. During the monitoring process the department may recommend modifications to the manufacturing system that may help avoid adverse events.  The Department of Medical Device Supervision oversees any issues that arise during the manufacturing and distribution of China medical devices as well.

How are China medical devices classified?

There are certain similarities to the classification of China medical devices when compared to US and European standards. The NMPA categorizes medical devices into 3 classes (from I to III) depending on their potential risk to patients. Class I being the lowest risk and Class III being the most complex and of highest risk.

Specifically, devices in China are categorized into these classes:
China Medical Device Class I – medical devices for which routine administration is adequate for safety and effectiveness.

China Medical Device Class II – medical devices for which further control is required to ensure safety and effectiveness.
China Medical Device Class III – medical devices with life support, and sustenance functions, including those pose a potential threat to patients’ health or are implanted into the human body.

For overseas manufacturers: what do I need to know about registering a medical device in China? 

Previously, medical device registration was only valid for 4 years. Now the term of  medical device registration is five years and is only necessary for class II and class III devices due to their higher risk to patients. Class I devices are still required to file but they are not required to be registered.

Registering a medical device that is not manufactured in China means a company must submit samples of the device to NMPA for analysis. Class II and III devices require records proving the device has been approved in its original country. Additionally, all product information must be translated in Chinese. This includes labeling and packaging. Lastly, foreign manufacturers may be required to send additional data from clinical trials when registering their Class II and Class III medical devices.

Overseas manufacturers are also required to hire a China-based agent to register products outside of China. The agent provides maintenance support and technical service, oversees the registration and clinical trial process, and manages adverse events in case of device malfunction.  Furthermore, the China based agent can assist with device recall in the event that a recall is required.

Have there been any recent updates to the regulations in Registration & Clinical Trial Process in China? 

The NMPA published a revised draft of regulations on June 25^th 2018. There are 4 areas with significant updates to regulations.

I. Clinical Trials
Again, Class I devices and most Class II devices do not require clinical trials. Class III devices are only exempt from clinical trials if they have been proven safe for use. All high-risk devices must be evaluated in China. Because of this, manufacturers who conduct clinical trials outside of China may be subject to review.

Most importantly, accepting data from clinical trials performed outside of China speeds up the registration and clinical trial process.

II. Market Authorization Holder (MAH) System
MAHs are responsible for assuring the quality of medical devices. This includes submitting self-inspection reports and maintaining product information in the NMPA Unique Device Identification (UDI) database.

III. Unique Device Identification System
Created in 2018, the Unique Device Identification (UDI) system improves the monitoring of medical devices. The UDI database includes information like the device model, production and expiry dates of the device, as well as the device UDI code.

IV. Innovative Device Prioritization
Foreign manufacturers may now import innovative devices into China without certification of market entry approval from the device’s country of origin.