Data Requirements for Medical Device Software Registration

Ⅰ. Application Scope
The guidance is applicable to the registration of medical device software, including self-developed software, partly using off-the-shelf software and all using off-the-shelf software.
Medical device software includes: independent software (software as medical device or accessory) and software component (software as component of medical device or its part of accessory).
Ⅱ. Data Requirements for Medical Device Software Registration
1. Product Name and Structure

	Independent software	Software component
Name	According to human body parts, clinic department, processing object and function	According to human body parts, clinic department, processing object and function
Structure	Including physical and logistic composition; physical composition describe storage medium and delivery of software, logistic composition describe clinic function modules.	Including software name, model and version model.

2. Software description document
(1) Application Requirement
The manufacturer shall provide a separate description document of medical device, including basis information, implementation process and core algorithm. The detail degree of the description depends on the security level and complexity of the software. According to the possible damage level, the software safety classes (YY/T 0664-2008) shall be assigned based on severity as follows:
Class A: No injury or damage to health is possible
Class B: Non-serious injury is possible
Class C: Death or serious injury is possible
For Class B and C software, some software description documents should be original files.
The detailed requirement of medical device software description document is listed in the following table:

Description Document	Level A		Level B			Level C
Basic Information	Product Identification	Provide the name, model, version model, manufacturer and manufacturer site of medical device.
	Safety Class	Describe the safety class of software and explain the reason in detail.
	Architecture Function	Provide system architecture diagram based on Software Design Specification (SDS).
	Hardware Relationship	Provide physical topology graph based on Software Design Specification (SDS), which shows the physical connection relationship between medical device software, general computer and medical device hardware.
	Runtime Environment	Describe the hardware configuration, software environment and network condition during runtime.
	Indications	Describe the indications of the software (For software component, please describe the indications of the medical device).
	Contraindications	Describe the contraindications or usage limitation (For software component, please describe the contraindications or usage limitation of the medical device).
	Registration History	Describe the registration condition, including the vision number and registration number. (For software component, please describe the registration condition of the medical device).
Implementation Process	Development Review	Describe the language, tool, method.
	Risk Management	Provide the risk management report. (For software component, please describe the risk management report of the medical device).
	Requirement Specification	Provide the function requirement of requirement specification.	Provide the full text of requirement specification.
	Lifecycle	Provide the abstract of software development lifecycle plan.	Attach management plan and maintenance plan on the basis of Class A.		Attach input and output control document on the basis of Class B.
	Verification and Validation	Provide plan and report abstract of system testing and user testing.	Describe the validation activity of each development stage on the basis of Class A.		Provide traceability analysis report on the basis of Class B.
	Defect Management	Describe the flow of defect management; list the number of total defects and remaining defects.	List the condition of remaining defects on the basis of A.
	Revision History	Describe the convention of version number and list all the revision activities, including version number, date and type.	Listing the update content in detailed on the basis of A.	Describe the convention of version number and list all the revision activities of each revision of software after initial legally marketed version, including version number, date, type and update content in detailed.
	Clinical Evaluation	Provide clinical evaluation document.
Core Algorithm	List the name, type, use and clinical features of core algorithm.		List the name, type, use and clinical features of generally acknowledged core algorithm. Provide the validation document in safety and effectiveness of new algorithm.

3. Software Vision
Provide authenticity statement of the naming rule of software vision.
4. Document of Product Technical Requirements
The document of independent software includes product vision and the specification instruction, performance indicators, detection methods and appendix.
The information of software component shall be described in the document of product technical requirements of medical device.
5. Clinical Evaluation Document
6. Product Instruction

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