Clinical evaluation of ventilators has new technical review guidelines issued by the Center for Medical Device Evaluation (CMDE) under the National Medical Products Administration (NMPA) on July 10, 2023.
The guidelines is intended for registration applicants and technical evaluation departments to follow in order to ensure the safety and efficacy of ventilator products in the Chinese market. As a reputable regulatory consultant company in China, Cisema helps medical device manufacturers navigate the complex regulatory process and meet the stringent requirements set forth by the NMPA.
Purpose of the review guidelines
The primary objective of these guiding principles is to provide regulatory guidance for registration applicants undertaking clinical evaluations of ventilators of the same category. Additionally, they serve as a reference for technical evaluation departments to assess comparative clinical evaluation data of these ventilator products.
Scope of Application
These guiding principles are applicable to a range of ventilator products used for life support, including treatment ventilators, emergency and transport ventilators, and high-frequency oscillatory ventilators. The scope also includes non-invasive ventilators used for life support. These products fall under the III category, as per the existing Medical Device Classification Catalog.
Basic Requirements for Clinical Evaluation of Ventilators of the Same Category
The guidelines emphasize the importance of selecting ventilators with similar technical features and applicability to the products being registered. Comparative evaluations must include clinical indications, applicable user groups, environmental suitability, magnetic resonance compatibility (if applicable), clinical functionalities, contraindications, and physiological functions in the case of high-frequency oscillatory modes.
Comparative Analysis of Technical Features
To ensure the safety and efficacy of the registered ventilator products, comprehensive comparisons of technical features between the applicant’s product and other ventilators of the same category are necessary. Parameters such as basic principles, structural composition, performance requirements, software core functionalities, and monitoring parameters should be examined for similarities and differences.
The evaluation should demonstrate equivalence of ventilation waveforms between the applicant’s product and other ventilators of the same category. The analysis should include period, shape, inflection points, amplitude, slope, and PEEP values, and must establish the safety and efficacy of the applicant’s product. Other parameters, where differences exist, can be evaluated through non-clinical validation to prove safety and efficacy.
Utilizing Clinical Data from Similar Products
Where applicable, clinical data from similar ventilators can be used as supporting evidence for the registration application. This may include adverse events, clinical trial data, literature data, clinical experience, and corrective actions related to clinical risks. The data selection should be based on the maturity of the technology, the level of risk, and the extent of benefit for similar products.
Read the original CMDE announcement on registration review guideline for clinical evaluation of ventilators.
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