How to Confirm the CFDA Registration Unit for Medical Device Software

August 5^th 2015, CFDA issued ‘Medical Device Software Registration Audit Guideline’. This guideline regulates medical device software CFDA registration unit (one registration certificate included several models or specifications) and test unit (test one model for several similar models) confirmation. And the registration unit and test unit for the independent software and software components are diverse. Companies can confirm the registration unit and test unit along the following rule.

I. How to confirm the registration unit

Independent software
Independent software registration unit depends on its manage categories, intended use, process objects and clinical functional module.

Manage categories: Different manage categories will have different registration unit. For the multifunction independent software that might be in different manage categories, the registration unit is subject to the highest manage categories.
Intended use: Different intended use will be in different registration categories. Intended use includes therapy program, diagnose, monitoring and information management in general.
Process objects: Different process objects are included in different registration categories. The medical device software process objects mainly contain image type and data type.
Clinical functional module: For the multifunction independent software, the registration unit is subject to clinical function module type and amount. Each registration class should have moderate amount of clinical function module. Based on the module function, it can be platform function software or particular function software. The platform function software can have basic and sharing function. It can support the multiple modes of image and data. But for the particular function software, it has specific function. It only supports the single mode image and data or implements the special intended use. (Ex: PACS includes ten independent clinical functional modules. These modules also include CAD type module. PACS can be classified into platform function software and multiple particular function software. And the CAD module should be classified as an individual registration unit.)

Software component
Software component meet the medical device definition, so it should register with the medical device. The registration unit should be the same as the medical device.
If the dedicated independent software is regard as software component, the requirements are the same as the software component.

II. How to confirm the test unit

Independent software
The test unit is almost the same as registration unit. But if there are multiple operating environments or version, each incompatible operating environments or different version should be in one test unit.

Software component
Software component test unit is the same as the medical device in general. However, the medical device includes multiple software components or different software versions. Then each software components and software versions should be a different test unit.

When the dedicated independent software is divided into software components, the test unit is the same as the software components. But if there are multiple operating environments, each incompatible operating environment will be a different test unit.

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