【Case Study】Blood Glucose Meter Registration in China

1. Introduction

Product Name: Blood Glucose Meter

Product Composition:

generally consists of detection module, signal amplification module, AD acquisition module, data processing module, display module, embedded software, signal output part (if applicable), power supply circuit and button control circuit.

Working Principle:

1) Electrochemical method: The principle of detecting the current signal generated during the reaction of the enzyme is used to reflect the blood sugar level. The electrons generated by the reaction between the enzyme and the glucose pass through the current counting device, and the quantity of the electron is read and converted into a glucose concentration reading. According to the enzyme used in the electrochemical blood glucose test strip, it is divided into two types: glucose oxidase (GOD) method and glucose dehydrogenase (GDH) method. GDH is also required to use different coenzymes in the reaction, namely pyrroloquinolinequinone-dependent glucose dehydrogenase (PQQ-GDH), flavin adenine dinucleotide glucose dehydrogenase (FAD-GDH) and nicotinamide adenine dinucleotide glucose dehydrogenase (NAD-GDH).

2) Photochemical method: It is to detect the color change of the test strip during the reaction to reflect the blood sugar level. The enzyme used in the blood glucose test strip is generally GOD, an intermediate produced by the reaction of the enzyme with glucose (with color substance). After the reaction, the color of the test paper changes, and the absorbance of the reflective surface of the test paper is detected by a detector, and the blood sugar concentration can be obtained according to Lambert-Beer's law.

Typical Structure:

Typical StructureBlood Glucose Meter  Blood Glucose Meter

Scope of application: Used in conjunction with blood glucose test strips for quantitative detection of glucose concentrations in human capillary whole blood and/or venous whole blood and/or arterial whole blood (also plasma/serum)

Applicable people: blood glucose test for ordinary people or newborns (Note: There is a big difference between blood of newborns and ordinary people. The reference value of blood glucose test and the range of hematocrit are different. If it can be used for neonatal testing, relevant verification data should be provided)

Because glucose dehydrogenase products need to be combined with different coenzymes, they are easily interfered by other sugar substances. Different enzymes have different adaptation groups, and different enzyme technology blood glucose meters should be selected according to different patients' conditions.

Expected use environment: The reaction process of blood glucose test products using glucose oxidase method requires oxygen participation and is susceptible to oxygen interference. Therefore, the altitude should be specified (Note: altitude verification data should be given)

Contraindications: disabled patients with coagulopathy

2. Classification

Classification Code: 22-02-02 Class II Blood glucose and blood glucose related parameter analysis instrument

Product Description: It is usually composed of a host module, a power module, a software module, and the like. The principle is generally an electrochemical method, a light reflection technique, a colorimetric method, and the like. Blood collection equipment and adaptation reagents are not included.

Expected Usage: Used in conjunction with an adaptation reagent for qualitative and/or quantitative analysis of the analyte in a human sample.

3. Registration Unit

1). principle is different

For example, a blood glucose meter that uses the electrochemical method as the basic principle and a blood glucose meter that uses the photochemical method as a basic principle should be classified into different registration units.

2). Differences in performance indicators

If there are large differences in performance indicators, consideration should be given to dividing into different registration units.

4. Technical Requirements

1). Blood glucose meter appearance

2). Blood glucose meter and supporting blood glucose test strip system for measuring repeatability

Test range

Precision

5.5mmol/L(100mg/dL

SD0.42 mmol/L(7.7mg/dL

≥5.5mmol/L(≥100mg/dL

CV7.5%

3). Accuracy of blood glucose meter and blood glucose test strip system:

95% of the deviation of the measurement results of the blood glucose meter and the supporting blood glucose test strip shall meet the requirements of the following table;

The recovery rate of glucose from blood glucose meter and blood glucose test strip is 80% to 120%.

Test range

Allowable deviation

≤4.2mmol/L(≤75mg/dL)

No more than±0.83mmol/L(±15mg/dL)

4.2mmol/L(75mg/dL)

No more than ±20%

4). Data transmission reliability requirements (if applicable)

5). Blood glucose meter safety requirements

6). Electromagnetic compatibility

7). Blood glucose meter environmental test

Table 1 Relevant Product Standards

Standard Number

Standard Name

GB/T 191-2008

Packaging storage and transportation icon

GB 4793.1-2007

Safety of electrical equipment for measurement, control and laboratory use - Part 1: General requirements

GB 4793.9-2013

Safety of electrical equipment for measurement, control and laboratory use - Part 9: Particular requirements for automatic and semi-automatic equipment for laboratory analysis and other purposes

GB/T 14710-2009

Medical electrical environment requirements and test methods

GB/T 19634-2005

General technical conditions for self-test blood glucose monitoring system for in vitro diagnostic test system

GB/T 18268.1-2010

Electrical equipment for measurement, control and laboratory - Electromagnetic compatibility requirements Part 1: General requirements

GB/T 18268.26-2010

Electrical equipment for measurement, control and laboratory use - Electromagnetic compatibility - Part 26: Particular requirements In vitro diagnostic (IVD) medical devices

YY/T 0316-2008

Medical device risk management for medical devices

YY/T 0466.1-2009

Medical devices - Symbols for labeling, marking and providing information on medical devices - Part 1: General requirements

YY 0648-2008

Safety of electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical devices

ISO 15197:2013

In Vitro Diagnostic Test System - General Technical Requirements for Self-Test Blood Glucose Monitoring System for Diabetes Management

Glucometer registration technical review guidelines

Does not include minimally invasive blood glucose meters, non-invasive blood glucose meters, continuous blood glucose meters, and blood glucose meter products that embed blood glucose detection modules in mobile devices or that need to transfer data to mobile devices for display and analysis

YY(/T): Industry standard (Recommendation)

GB(/T): National standard (Recommendation)

5. Clinical Trials

Animal Test or Small Sample Test: not required

Clinical Trials: not required

In ‘Medical Device Catalog Exempted from Clinical Trials’

Usually composed of a host module, a power module, a software module, and the like. The principle is generally an electrochemical method, a light reflection technique, a colorimetric method, and the like. Blood collection equipment and adaptation reagents are not included. Used in conjunction with an adaptation reagent for qualitative and/or quantitative analysis of the analyte in a human sample.

6. Registration Cost and Duration

1) Product Testing

Test items

Testing duration

Testing fee(USD)

Safety Performance

60

4,000

EMC

60

3,500

SRRC

Half a year

5,500

Notes:

1). The price of each item is only the price of one operating mode. If there are multiple operating modes, it needs to be re-priced;

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

Ms. Shuo Wang (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