Medical device comparison of the same variety of clinical evaluation method to the medical device registrant has brought more choices, conditional to use the same variety of clinical evaluation method, enterprises should give priority to this clinical evaluation path, compared with medical device clinical trials, the same variety of clinical evaluation method has significant advantages in terms of time and cost. This article will talk about the same variety of medical devices, including several situationsLet's look at the text together.
The clinical evaluation path of the same variety is adopted, and the same variety of medical devices includes several situations
The same variety of medical devices has been approved for registration in China. It can be divided into two situations: equivalent devices and comparable devices.
In accordance with the relevant requirements of the Technical Guidelines for the Demonstration of Equivalence in Clinical Evaluation of Medical Devices, the equivalent device shall demonstrate the equivalence between the declared product and the comparison product. Clinical evaluation can be performed through clinical data of equivalent devices.
Although the comparable device cannot be demonstrated to be equivalent to the declared product, it should be widely similar in terms of scope of application, technical characteristics or biological characteristics, and the clinical data of the comparable device can be used as part of the clinical evidence of the declared product.
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