According to the《Regulations for the Supervision and Administration of Medical Devices》, applicant must submit the clinical evaluation documents while registering or recording to guarantee the safety and effectiveness of medical devices. The China Food and Drug Administration (CFDA) has issued《Technical Guiding Principle on Medical Devices Clinical Evaluation》(not apply to in vitro diagnostic reagent) on May 19,2015 to provide guidance for applicant.
Clinical evaluation is a procedure for applicant to confirm whether the product can conform to operating requirement or application by clinical literatures, clinical experience data, clinical trial and other information.
The basic principles of clinical evaluation are as follow:
Clinical evaluation is a procedure for applicant to confirm whether the product can conform to operating requirement or application by clinical literatures, clinical experience data, clinical trial and other information.
The basic principles of clinical evaluation are as follow:
1. Comprehensive and Objective: Collect corresponding data no matter the data is favorable or unfavorable by clinical trial and other means.
2. The depth and breadth of clinical evaluation, and data type and size should match with the performance of the product, such as design feature, key technology, intended use and risk degree, as well as degree of non clinical research.
3. The content should be confirmed by clinical evaluation
- Application range: applies to people, applicable parts, contact form, indication, degree and stage of diseases, usage requirement, usage environment, etc.
- Usage method
- Contraindication
- Precautionary measure
- Warning
- Other information
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