New for the apparatus review: Q&A on clinical exemptions!

Q: If multiple single-free clinical trial in vitro diagnostic reagents are combined into multiple joint testing products, can they be exempted from clinical trials?，

A. According to the Guiding Principles for Division of Registration Units of Medical Devices, the tested substances in the joint inspection items should have the significance of collaborative diagnosis for specific indications; otherwise, joint inspection is not recommended. Secondly, confirm the consistency between the product and the product of the clinical free catalog. The items to be tested should be consistent with the detection target of the clinical free catalog and the scope of product description, and joint testing will not expand the scope of application of the product. In this case, multiple joint testing products can be exempted from clinical trials.

Q: Transcatheter heart valves and delivery systems have been clinically tested and listed in China. Later, without any change in the transcatheter heart valves, only the delivery systems have been improved. Which clinical path is appropriate for application?

A. The applicant should specifically analyze whether there is an impact of changes in the delivery system on product performance and clinical safety, while focusing on preclinical research data is sufficient to support the differences do not have an impact on product safety and effectiveness, such as analysis and evaluation is acceptable, and non-clinical information and similar products outside the country with the same improved application of clinical data can support, you can choose the same species path for clinical evaluation.

Source：NMDE

Translated & edited by Bradyknows