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Introduction of Medical Device Software Registration Application Requirement

Introduction of Medical Device Software Registration Application Requirement
Introduction of Medical Device Software Registration Application Requirement

Introduction of Medical Device Software Registration Application

Requirement

I.Applicable Scope

The guidance is applicable to the initial registration and registration renewal of imported products and Class III domestic products, and also applicable to self-developed software, partly using off-the-self software and completely using off-self-software. It includes:

(1) Independent software: Software as medical device or accessory,such as processing software,data software.

(2) Software component: Software as component of medical device, part or accessory, such as embedded software, control software.

(3) Specialized software: Other special purpose software,such as individual customer-made software.

II.Application Requirement

The manufacture should provide a single descriptive document of medical device software, including basic information,implementation process and core algorithm.The required documents are different according to the safety and complexity level of the software. The software safety class(refer national standard for medical device software safety classification YY/T 0664-2008) is listed as below:

A: No harm or injury to health

B: May cause slight injury

C: May cause death or serious injury

For class B and C software, original document of the content in the descriptive document should be provided. The general requirements of the descriptive document are listed in chart 2:

chart2:Requirements of the descriptive document for medical device software

Descriptive document Class A(slight)Class B(medium)Class C(serious)

Basic information

Product

Identification Describe the name, model, version No., manufacture and manufacturing site of the software Safety class Describe the safety class of the software.Explain in detail how the safety class is determined Architecture

Function

Describe software component module,module function, relationship among component modules,

external interface, and user interface based on system architecture diagram.

Hardware

Relationship

Describe the physical connection relationship among software, general purpose computer, and

medical device hardware based on physical topology graph.

Runtime

Environment Describe required hardware configuration, software environment and network condition.

Indications Describe the indications and applicable population of the software.

Contraindications Describe the contraindications and non-applicable population of the software

Listing History Describe the initially marketed time, version number and management classification in China,country of origin, and other main countries.

Implementation

Process Development

Review

Describe the development language, tool, method,model, personnel, time, workload, lines of code

and quantity of control documents.

Risk

Management Provide Risk Management documents

Requirement

Specification

Describe the function and

performance requirement of

software requirement

specification(SRS)

Provide the whole software requirement specification include

requirement in hardware, function, performance,input and output,

interface, warning information, security and secrecy, data and

database,documents and regulations

Lifecycle The abstract of software

development lifecycle plan

The abstract of software

development lifecycle plan,

configuration management plan

The abstract of software

development lifecycle plan,

configuration management plan

and maintenance plan and maintenance plan. List input

and output documents of each

stage

Verification and Validation Provide system testing plan,

user testing plan and report

abstract

Summarize the validation activity

of each development stage.

Provide system testing plan,

user testing plan and report

abstract

Summarize the validation activity

of each development stage.

Provide system testing plan,

user testing plan and report

Defect Management Describe the number of total

defects and remaining

defects

Describe the number of total defects and remaining defects.List the

severity grade,treatment measures and handling time of the

remaining defects

Revision History Describe the naming

conventions of software

version number and list the

revision version number,

type and revision date of

this version.

Describe the naming conventions

of software version number and

list the revision version number,

type and revision date of this

version.Describe in detail the

modification content between this

version and the previous one

Describe the naming conventions

of software version number and

list the revision version number,

type and revision date of this

version and the previous ones.

Describe in detail the

modification content between

this version and the previous one

Clinical

Evaluation

Provide Clinical Evaluation documents

Core Algorithm For recognized mature

algorithms,please list the

name; for new algorithm,

please list name,principle

and intended use

For recognized mature algorithms,please list the name,principle and

intended use; for new algorithm, please list name,principle,

intended use and safety&effectiveness validation documents

Attach:partly using Off-the-shelf

Software Pls refer requirements in

Architecture Function,Risk

Pls refer requirements in Architecture Function,Requirement

Specification,Risk Management,Lifecycle,Verification and

Management and

Validation,Defect Management Verification and Validation

1. Basic Information

1.1 Product Identification

Provide the name,model, version, manufacturer and manufacturing site of medical device software.Note: Software component should be internal identifier.

1.2 Safety Class

Describe the safety class of software based on the function, intended use and application environment of software.Explain in detail how the safety class is determined

1.3 Architecture Function

Provide system architecture diagram based on Software Design Specification (SDS), which shows the relationship among component modules of software, and the relationship between component modules and external interface.

Describe component module function, relationship among component modules, relationship between component modules and external interface, and user interface based on system architecture diagram.

For component modules, please identify that optional configuration or not, version number. For off-the-shelf software, please identify its version number/ manufacturer name / type (outsourcing,ready-made, legacy).

1.4 Hardware Relationship

Provide physical topology graph based on Software Design Specification (SDS), which shows the physical connection relationship among software, general purpose computer, and hardware.

Describe the physical connection relationship among software, general purpose computer, and hardware based on physical topology graph.

1.5 Runtime Environment

Describe required hardware configuration, software environment and network condition.

Hardware configuration includes central processing unit (CPU), memory, peripheral components,and I/O device.

Software environment includes system software, supporting software, essential software,optional software, and anti-virus software.

Network condition includes network interface, network type (local area network-LAN,wide area network-WAN), and network architecture (CS, BS).

1.6 Indications

For independent software, please describe the indications and applicable population of the software.

For software component, please describe its function purpose as a whole, and the indications and applicable population of the medical device.

1.7 Contraindications

For independent software, please describe the contraindications and non-applicable population of the software.

For software component, please describe its disable function as a whole, and the contraindications and non-applicable population of the medical device.

1.8 Listing History

For the initial registration of the software in China, please identify the management classification based on "Classification Catalog of Medical Device" and subsequent notices of classification definition.

For the registration renewal of the software in China, please list the version number and registration number of all the legally marketed products in China. Please also list the initially marketed time, version number and management classification in country of origin, and other main countries and areas, such as USA, Japan and Europe etc. For software component, please describe the listing history of the medical device (including the software component)

2. Implementation Process

2.1 Development Review

Please describe the language, tool, method and lifecycle model used in development process.For tool, please describe the name, version number and manufacturer of supporting software(include open-source software) and application software (third-party software).Please also describe the number of developers, development time, working load (number of person and month), total number of code line, and total number of control document.

2.2 Risk Management

Please provide the risk management report which includes name, severity, reason, mitigation measures and result.

Please attach original files to describe the implementation of risk management.

For software component, please provide the risk management report of medical device.If using off-the-shelf software as component module, please describe the risk management to all the classes of the software.

2.3 Requirement Specification

For Class A software, please describe the function and performance requirement of software requirement specification(SRS).

For Class B and C software, please provide the whole software requirement specification. The whole software requirement specification include requirement in hardware, function, performance,input and output, interface, warning information, security and secrecy, data and database,documents and regulations Please attach original files to provide the software requirement specification.

For software component, please provide the requirement specification of medical device. If using off-the-shelf software as component module, please describe related requirement for Class B and C software.

2.4 Lifecycle

For Class A software, please provide the abstract of software development lifecycle plan, and describe the task, content and result of each stage.

For Class B software, please provide the abstract of software configuration management plan and maintenance plan, and describe the corresponding tool, flow and requirement on the basis of Class A.

For Class C software, please list input and output control documents of each stage on the basis of class B.

Please attach original files to describe the implementation of lifecycle. The checklist form in IEC62034-2006 0r IEC60601-1-4 can be used as reference.

If using off-the-shelf software as component module, please describe related requirement in development lifecycle plan, configuration management plan and maintenance plan for Class B and C software.

2.5 Verification and Validation

For Class A software, please provide system testing plan, user testing plan and report abstract,and describe the testing condition, tool, method, pass criteria and result.

For Class B software, please introduce the validation activity of each development stage briefly,and describe the corresponding tool, method, content and result. Among them, please describe the coverage for unit testing, and the integration strategy for integration testing. Please provide system testing plan, user testing plan and report abstract.

For Class C software, please introduce the validation activity of each development stage briefly,and provide the system testing plan, user testing plan and report.

Please attach original files for system testing and user testing. Please also provide traceability analysis report as reference.If using off-the-shelf software as component module, please perform the verification and validation to all the classes of software.

2.6 Defect Management

For Class A software, please describe the tool, flow and requirement of defect management, and list the number of total defects and remaining defects which are found in development stage.

For Class B and C software, please list the severity grade,treatment measures and handling time of the remaining defects on the basis of Class A.

If using off-the-shelf software as component module, please list all the remaining defects for Class B and C software.

2.7 Revision History

For Class A software, please describe the naming conventions of software version number, and list all the revision activities including version number, type (improvement, adaption, correction)and revision date in country of origin.

For Class B software, please describe in detail the modification content between the version and the previous legacy marketed version of the software in country of origin on the basis of Class A(that means the manufacturer also should describe the naming conventions of software version number, and list the revision number, type and revision date of the version). For Class C software, please list each revision of the software after initial legally marketed version, including version number, type and date of being approved into market in country of origin on the basis of Class B(that means the manufacturer also should describe the naming conventions of software version number, list the

revision number, type, and revision date of the version, describe in detail the modification content between the version and the previous legacy marketed version of the software)

2.8 Clinical Evaluation

The clinical evaluation document includes literatures, clinical data and clinical trial report. The original files should be attached.

3. Core Algorithm

Please list the name,principle, intended use and type of core algorithm based on Software Design Specification (SDS) and IFU.The core algorithm includes post-processing algorithm and artificial intelligence algorithm.Post-processing algorithm can generally change original images or date, including but not limited in compression, segmentation, registration and fusion, 3D reconstruction, quantitative analysis and abnormal recognition.Artificial intelligence algorithm generally performs analysis and treatment based on database,including but not limited in pattern recognition, neural network and expert system.Type means generally acknowledged mature algorithm (published literature patent standard, principle which is simple and clear, being into the market over 4 years without adverse events) and new algorithm (derived from scientific research and clinical data).

The level of specificity of submitted core algorithm document depends on the safety class and complication level.

For Class A software, it is ok to just list name of generally acknowledged mature algorithm, and describe principle and purpose of new algorithm.

For Class B and C software, it should list name and describe principle and purpose of generally acknowledged mature algorithm, and provide the validation document in safety and effectiveness of new algorithm in addition to describing its principle and purpose.

For the initial registration of software, please list the name, principle, purpose and type of all the core algorithms.

For the registration renewal of software, please list the name, principle, purpose and type of new added core algorithm.

III Off-the-shelf Software

The manufacturer should manage off-the-shelf software based on risk management method. If partly using off-the-shelf software, the application requirement for outsourcing, ready-made,legacy software is completely same (see previous clause).

If completely using off-the-shelf software, the application requirement is as

follows:

(1) For outsourcing software, it should provide outsourcing contract and software

description document.

(2) For ready-made software, it should provide purchase contract and software

description document (please identify the reason for N/A).Please also provide copy of registration certificate and the corresponding document if has been approved in China.

(3) For legacy software, please provide copy of registration certificate and software

description document (please identify the reason for N/A).

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商务英语口语对话 商务英语实用口语对话 在商务交谈的`时候,有哪些是实用的对话呢?以下内容由应届毕业生为大家的商务英语实用口语对话,希望能帮助到您! 我从广告上得知你们生产打印机。 I see from the advertisement that you arc making printers. 可否报G21型的价格? Would it be possible to give us the prices to your model G21 ? * Can you give me the offer for your model Ci21 ? * Can you make me the offer for your model Ci21 ? * Can you quote the price for your model G21 ? 请告知您要的数量。 May I know your quantity? * What’s your quantity?

请报100台的价格。 Please give me the quotation based on 100 sets. * Please quote me the price for 100 sets. * Please otter me the price for 1 00 sets. 要FOB价,CFR价,还是VIF价? Do you want FOB price. CFR price or CIF price? 请报纽约海运价。 Please quote the price based on CIF New York by sea freight. * Please offer us CIF price to New York by sea freight. 好的。可是现在我.们外销经理不在,请,您留下电话、姓名,他一回来,我就马上.报价给您。 OK. Since our Export Manager is not in the office now would you please leave your name and telephone number? We’ll offer you as soon as he es back.

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