1.The propose of Comparison with Predicate Medical Device
- Applicant/registrant can 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.
2.The significance and principle of Comparison with Predicate Medical Device
- The applicant/registrant shall prove that the subject product are SE to the products approved for domestic registered device in aspects such as basic principles, structure compositions, manufacturing materials, production process, performance requirements, safety evaluation, coincident national/industrial standards and intended use.
- At the same time, the applicant/registrant should prove the difference existing exerts no adverse effect on safety and effectiveness of products.
3.Content of Comparison with Predicate Medical Device
- Comparison Process
- Judgement: Comparison of subject product with predicate medical devices proves that they are SE.
- Data Collection
- Statistical Analysis of Data and Data Evaluation
- Clinical Evaluation Report: Following the completion of clinical evaluation, a clinical evaluation report shall be composed and submitted as clinical evaluation data at applying for registration.
