Medical device clinical evaluation refers to the process in which the applicant validates whether the products meet use requirements or scope of application through information such as clinical literature, clinical experience data and clinical trials.
All medical device need Clinical Evaluation, but requirements for clinical evaluation data may be different fueled by varied application scope of medical device leading to various risks throughout the use.
2.Types of Clinical Evaluation
For Products listed in Catalogue of Medical Devices Exempted from Clinical Trials (hereinafter referred to as new Exemption Catalogue), applicant/registrant should submitted two part of clinical evaluation data.
√ One part is contrast data of subject product-related information to the contents described in Exemption Catalogue.
√ The other part is Explanation on comparison of subject product to the medical devices approved for domestic registration in Exemption Catalogue
Though comparison with predicate medical device: Applicant/registrant should compare the subject product with one or more predicate medical devices to demonstrate that they are substantial equivalent (SE), according to the clinical trials or clinical application data of predicate medical device.
Clinical Trials: Clinical trial refers to the research study conducted by an institute with corresponding qualification, in which the safety and effectiveness of a medical device to be registered is investigated under its normal service condition.
3.TIPS
The Class III medical devices of higher risk shall be approved by the Medical Administration Department under the State Council prior to clinical trials.
NMPA issued the Catalogue of Class III Medical Devices Requiring Approval of Clinical Trials (No. 14, 2014). The clinical trial protocol of products listed in Catalogue can be implemented only in the territory of China.
