China Updates Medical Device Clinical Evaluation Pathway Guidance

In March of 2024, the Center for Medical Device Evaluation (CMDE) added 25 devices to the “Guidelines for Deciding Whether to Conduct Clinical Trials on Medical Devices” (pdf, original Chinese), originally published in June of 2022.
The guidance provides crucial information to medical device manufacturers wishing to register their products for importation and sales on the Chinese market regarding how to meet the requirements for clinical evidence.

Understanding Clinical Evaluation in China

Clinical evaluation is a critical step in the registration process for medical devices in China. This involves validating whether a medical device meets its intended use requirements or scope of application through clinical literature, clinical experience data, and clinical trials. For all Class II and Class III medical devices, clinical evaluation is mandatory, though requirements vary based on the device’s application scope and associated risks.

NMPA Regulations and Types of Clinical Evaluation

The National Medical Products Administration (NMPA) outlines three types of clinical evaluations:

1. Exemption from Clinical Evaluation:

• If a product is listed in the “Catalogue of Medical Devices Exempted from Clinical Evaluation,” (pdf, original Chinese) the applicant must submit two comparison tables:
  • One comparing the subject device to the contents described in the Exemption Catalogue.
  • Another comparing the subject device to a similar NMPA-registered device.

2. Clinical Evaluation Report (CER):

• The applicant should compare the subject device with one or more NMPA-registered predicate devices to demonstrate substantial equivalence (SE). This comparison relies on clinical trials or application data from the predicate devices.

3. Clinical Trials:

• Conducted by qualified medical institutes, these trials investigate the safety and effectiveness of the subject device under normal conditions.

New Guidance from CMDE: Clinical Evaluation Recommendation Pathways

Registering a medical device in China can be challenging, especially when determining the appropriate registration pathway. If a device is not on the clinical trial exemption list, manufacturers must decide whether to conduct a clinical trial or submit a CER. The “Guidelines for Deciding Whether to Conduct Clinical Trials on Medical Devices” provide some direction, but often, a clinical trial report is still required.

In mid-2022, the China Center for Medical Device Evaluation (CMDE), the technical review authority under the NMPA, issued a comprehensive clinical evaluation recommendation pathway for medical device registration. This pathway is based on China’s Classification Catalogue of Medical Devices and clearly outlines whether a clinical evaluation exemption, CER, or clinical trial is recommended for most devices listed in the catalogue.

Current Status and Recent Developments

To date, the CMDE has provided recommendation pathways for nearly 1,683 types of medical devices. This guidance helps manufacturers identify the correct pathway for their devices, streamlining the registration process.
Listed below are the latest clinical evaluation pathway recommendations issued in March 2024: