Introduction to China Medical Device Registration
In China, the Medical Device Registration and approval are managed by the National Medical Medical Devices Administration (NMPA) formerly known as the China Food and Drug Administration (CFDA). The State Administration for Market Regulation (SAMR) supervises and oversees the activities of NMPA.
As per NMPA, a Medical device is an instrument, equipment, appliance, IVD, calibrator, or materials and other similar articles, including necessary computer software. The Medical Device Registration process in china is decided based on the classification of medical device.
China Medical Device Regulations
China’s medical device regulations are governed by the National Medical Products Administration (NMPA), formerly known as CFDA. The regulatory framework is risk-based and aligns with the China medical device classification system, which divides devices into Class I (low risk), Class II (moderate risk), and Class III (high risk). Each class has its own regulatory pathway, with Class I devices undergoing a simple notification process and Class II and III devices requiring rigorous technical review and often clinical evaluation.
The medical device approval in China involves appointing a local agent, compiling a registration dossier, submitting test reports, and, for higher-risk devices, undergoing clinical trials or submitting clinical evaluation reports. Understanding China medical device regulations is essential for successful market entry and ongoing compliance.
China Medical Device Classification System
As per Decree No.15 of the CFDA, the classification of Medical Devices in China is done based on the risk involved in the medical device. There are three category of medical device class as below:
- Class I Medical Device: Low-Risk Level, Safety, and efficacy can be managed through minimal management and supervision
- Class II Medical Device: Moderate Risk Level, stricter oversight for safety and effectiveness.
- Class III Medical Device: High-Risk Level, Rigorous assessment for maintaining the safety and efficacy of the device.
Process of Registration of Medical Devices in China
For Class I Medical Devices
Registration of medical device in China for Class I Medical Device, the agent submits the initial filing for records. The NMPA does not conduct a technical review specifically for Class I medical devices.
For Class II and Class III Medical Devices Registration process
- Appointment of Chinese Agent: A local representative of China is required to act on a Medical Device Manufacturer.
- Prepare Registration Dossier: Depending on the class of medical device, the technical dossiers are prepared and compiled for submission to the NMPA.
- Develop a Clinical Evaluation Report (CER): Various clinical trials are to be performed on medical devices, according to the medical device class, clinical trials shall be conducted and reports are to be submitted. Clinical trials are typically required for Class II and III devices unless exempted. On May 19, 2022, China’s NMPA issued guidelines to help manufacturers decide between seeking a clinical trial exemption, using predicate device comparisons, or conducting full clinical trials.
- Application Submission: After compiling all the necessary technical dossiers, the Agent applies for the registration of a medical device to the NMPA.
- After that, NMPA conducts a technical review of the application submitted and if needed NMPA requests additional information or questions.
- Application Approval & Issue of Certificate: After the technical review, the NMPA will approve the application and Issue the Certificate of Registration for the Medical Device.
- Post-Market Surveillance: Any adverse events or changes in the Medical Device shall be recorded and reported to the NMPA. Further required, periodical audits and inspections shall be conducted by NMPA to ensure that Medical Device compliance is followed.
