How to Compile Clinical Evaluation Documents for Clinical Trial Exempted Medical Device Software

Up to now, CFDA already issued two batches of clinical trial exempted medical device catalog. And the third batch was still the exposure draft.

In the following paragraph, CIRS will discuss about how to compile clinical evaluation documents for clinical trial exempted medical device software.

Clinical evaluation documents compiling is based on clinical trial differences during the CFDA registration process.
There are three main category:

The medical devices included in the clinical trial exempted catalog
Compare with the similar products
Clinical trial.

Reference: CFDA issued clinical trial exempted medical device catalog

CIRS summarized all the medical device software that exempted from clinical trial during the registration process. All the medical device software that conform to the description on the list can follow the steps listed in the following paragraph.

Product name	Product description	Class
Diagnostic image processing software	Used for human checkups image processing, including images such as digital X-rays, pathology, microscopy, infrared, ultrasound images and fused images and three-dimensional and dynamic image of original reconstruction images. Does not include automatic diagnosis section.	II
Diagnostic data processing software	Used for human checkups data processing, including ECG data, EEG data, EMG data, blood data, maternal and child care data. Does not include automatic diagnosis section.	II
Medical imaging, data processing software	Used for human checkups image, data management, view, transport and storage. Does not include automatic diagnosis section.	II
Semi-Quantitative Analysis Software For Allergen	Contains standard curve, used with ordinary scanners. Used for semi-quantitative detection of the test strip allergen-specific antibody and autoimmune antibodies according to western blotting and immunohistochemistry chromatography. Does not include automatic diagnosis function.	II
Blotting analysis software	Used for scanning bar code to achieve electron images by a plate scanister. Used for bar code location identification to identify band specificity. Does not include automatic diagnosis function.	II
Radiotherapy records and validation software	Therapeutic parameter verification before radiotherapy and therapeutic parameter record during radiotherapy	III
Radiotherapy outline software	The outline of the tumor and related organs and tissues before the radiotherapy plan.	III

Regulations reference for clinical evaluation documents.

The key points of clinical evaluation document compiling
Two main parts:

The comparison documents of declared product related information and the content in the clinical trial exempted medical device catalog.
The comparison explanation and related supporting documents of declared product. See chart 1for the comparison explanation.

*The submitted documents listed above should approve the equality of declared product and the listed products in the clinical trial exempted medical device catalog.

Chart 1
The comparison chart of declared product and the domestic listed products in the clinical trial exempted medical device catalog.

Compare item		Domestic registered medical devices in the exempted catalog	Declared products	result
Manufacture		A company	B company	/
Model				/
Working principle				same
Components				Same/different ,explain if different
Main function	Software processing object type			same
	General data-interface:			same
	Copyright protection:			Different
	Maintainability			same
	Clinical function			same/partial different
Applicable scope				same/partial different
Usage, working environment, operators’ requirements and etc.		Applicable places: hospitals, outpatient clinic operators’ requirements：	Applicable places: hospitals, outpatient clinic Operators’ requirements：	Same

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