Same-Variety Product Comparison
- Categories:Clinical Evaluation
- Time of issue:2021-03-25 15:00:41
In accordance with the requirements of NMPA, CRCS conducts analysis and evaluation through data obtained from clinical trials or clinical use of specific same-variety medical devices, which can make clients avoid re-doing large-scale clinical trials in China. Our services are as follows:
1.Determine the comparison product and evaluate whether the comparison product can be used as a same-variety medical device;
2.Prepare a comparison form of the same type of medical devices;
3.Analyze and compare the difference between the product to be registered and the same-variety product;
4.Develop a literature retrieval plan and qualitative evaluation standards for literature data;
5.Document retrieval and formation of document retrieval report;
6.Analyze whether there are racial differences in the clinical use of the product. If there is, the NMPA clinical evaluation guidelines should be followed to analyze and evaluate the use data of the Chinese population separately;
7.Based on all the above data and information, write the clinical evaluation report.
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The company specializes in medical device registration, in vitro diagnostic reagents registration, cosmetics agent service company, committed to the NMPA, CE regulation research and product registration and certification service has been more than 17 years.