【Case Study】Mobile Medical Software Registration in China

1. Introduction

Product Name: Mobile multi-parameter monitoring software, medical image storage transmission processing system, medical image processing software

Product Composition: Independent software or software component


2. Classification

Sub-category: 21 Medical Software

1. Primary Product Category: 02 Image processing software

21-02-01 Class II Medical image storage and transmission system software

Product Description: It usually consists of a software installation CD (or downloads the installer from the network). The image and/or video signals output by the medical imaging device are collected and stored in a computer hard disk for processing, transmission, display, storage, and output of images between departments and/or hospitals in the medical department.

Expected Usage: It is used for medical image receiving, transmission, display, storage, output and other processing for clinical diagnosis and treatment.


21-02-02 Class II Medical image processing software

Product Description: It usually consists of a software installation CD (or downloads the installer from the network). The image processing method is used to perform three-dimensional reconstruction and registration on medical images.

Expected Usage: Used to process medical images derived from single mode or multiple modes.

 

2. Primary Product Category: 03 Data processing software

21-03-01 Class II Monitoring software

Product Description: It usually consists of a software installation CD (or downloads the installer from the network). Data is acquired from the monitoring device by means of data communication, and real-time display and alarm are concentrated.

Expected Usage: Used to obtain data from the monitoring device, centralize real-time display, and alarm.

 

21-03-02 Class II Physiological signal processing software

Product Description: It usually consists of a software installation CD (or downloads the installer from the network). Analyze and/or transmit physiological signals such as EEG, ECG, and EMG collected.

Expected Usage: It is used for analysis, processing and/or transmission of physiological signals such as EEG, ECG and EMG.

 

3. Registration Unit

Possible situation:

The main model software needs to cover all the functions of other models;

Separate PC-side software and separate mobile software cannot be placed in one single registration unit.


4. Clinical Trials

21-02-01 Class II Medical image storage and transmission system software

21-02-02 Class II Medical image processing software

21-03   Data processing software

Clinical Trials: not required

The comparison of the medical software for clinical evaluation must be mobile software.


5. Technical Requirements

Table 1 Relevant Product Standards

Standard Number

Standard Name

GB/T 25000.51-2016

Software Engineering: Software Quality Requirement and Evaluation (SQuaRE) and Commercial off the Shelf (COTS) Packaging storage and transportation icon

YY/T 0316-2016

Medical device: risk management for medical devices

YY/T 0664-2008

Medical device software: software life cycle process

Medical Device Software Registration Technical Review Guidelines

Medical Device Network Security Registration Technical Review Guidelines

Mobile Medical Device Registration Technical Review Guidelines

YY(/T): Industry standard (Recommendation)

GB(/T): National standard (Recommendation)


6. Registration Cost and Duration

1) Product Testing

Test items

Testing duration

Testing fee(USD)

Software

30

4,500

Remarks:

1. Testing time and cost for independent software;

2. If it is a software component, consider the testing of the entire product.

2) Technology Approval

60 working days

Another 60 working days if the 1-year supplement is required

3) Administrative Approval

20 working days


If you would like to get the detailed registration proposal, please contact us via md@cirs-group.com.

Contact Us
CIRS China

Mr. Harold Xie (Head office)
Tel: +86-571 8720 6559 | Fax: +86-571 87206533
Email: md@cirs-group.com
Mr. Edwin Wen (Beijing office)
Tel: +86-10 63984062 | Fax: +86-10 63984032
Email: md@cirs-group.com

CIRS Europe

Bryan Zhou
Tel:  +353 (1)477 3710

Email: md@cirs-group.com

CIRS Korea
Mr. Junho Lee 
Tel: +82 2 6347 8801 
Email: md@cirs-group.com