NMPA organized the "2022 Revision of the Guidelines for Registration and Review of Continuous Glucose Monitoring System", and released the draft for public opinions on September 28, 2022, all comments will be collected by October 14, 2022.
Guideline Highlights
The guideline specified the key review points for CGMS registration, including registration unit division, predicate comparison scenarios, and special research materials. This guideline is highly recommended to be used for China NMPA registration of minimal invasive CGMS, and products with additional blood glucose, blood ketone, and other testing modules (blood glucose meters).
Registration Unit
The CGMS, including single-use glucose sensors, transmitters, and accessories, shall be registered as one registration unit. Except for the considering the sensor as the core component of the system and the basis of registration unit division. For example:
- Sensors with different materials, mechanism of action, designs, and the wearing days will be treated as separate registration units. Sensors with same design but different wearing days can be registered in the same unit through software settings.
- Retrospective and real-time CGMS should be divided into different registration units. A real-time CGMS system that includes a retrospective continuous glucose monitoring mode can serve as the same registration unit.
- Systems with significant differences in performance indicators should be divided into different registration units.
- Systems with significant differences in application scope achieved by either hospital or home applications used in conjunction with the product hardware, core algorithm, and performance indicators should be divided into different registration units.
Predicate Comparison Scenarios
- The guideline requires applicant to provide research background information and objectives of the predicates or previous generation products and explain the reasons for choosing the predicates: compare and explain the working principle, structural composition, manufacturing materials, performance indicators, and functions, application scope, sensor storage condition, operating temperature, and sterilization valid period of the product and the referenced product.
- The sensor performance indicators may at least include glucose monitoring range, linearity, response time, repeatability, stability, drug interference, temperature response, oxidation reaction, waterproof performance, sensor wearing time (hours), calibration times, alarm function, detection Frequency (minutes), data transmission method (Bluetooth/Near Field Communication), etc.
- The comparison shall emphasize the differences between the registered product and the predicate, as well as the rationale and performance of the identified differences
Special Research Materials
For the research materials should specify evaluation indicators, acceptance criteria, test methods (sample size and formulation basis, test equipment, test steps, etc.), data analysis methods, test results, and test conclusions.
I attached the Chinese guidance for your reference. If your device will be impacted by the guideline, please email us your comments info@ChinaMedDevice.com. We will help you submit your feedbacks to NMPA.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------