You may find it complicated and confusing when trying to navigate through China’s medical device classification, registration and clinical trials process. In addition, to make the matters worse, specific regulatory documents from NMPA are only available in Chinese (you can contact us for English copies). First of all, to begin to understand the NMPA’s process, you need to know about these 4 things that matter to medical device classification and registration in China.
China Medical Device Classification – What’s Important
These are the top 4 questions medical device and IVD community ask the most when learning about NMPA’s classification & registration process:
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.
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.
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.
The NMPA published a revised draft of regulations on June 25th 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.
Find latest posts from China Med Device about MAH system in China here.
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.
Find latest posts from China Med Device about the UDI system in China here.
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.
Find latest posts from China Med Device about this new innovative device path in China here.
Keep Updated with China Medical Device Classification & Registration
NMPA recently changed medical device classification, registration and clinical trials process in order to streamline and speed up the process. Therefore, understanding these 4 things about the registration and clinical trial process will help you better prepared for registering your device or IVD product in China.
Download a full version of NMPA medical device regulations here.
Finally, for overseas device manufacturers who are in the process or intend to enter China, sign up China Med Device’s weekly NMPA (CFDA) roundup newsletter here. Keep yourself updated.
About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a certified NMPA (CFDA) legal agent with offices in Boston and Beijing, we represent manufacturers for the complete product life cycle without their need to create a local entity in China. Specifically, our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.