Medical device procedures for self-testing glucose meters
Posted: May 2020, 7
As is the case worldwide, the number of patients suffering from diabetes is on the rise in Japan as well.
With the rapid aging of the population, which is said to continue into the future, it will take time for this to come to a halt.
One of the most important things for diabetic patients is
There is blood sugar control (control of blood glucose concentration) that is carried out on a daily basis.
This indicator is a device called a blood sugar level meter or blood sugar level measuring device.
Currently, devices that puncture the skin with a needle to draw blood into the device and measure blood sugar levels using a sensor inside the device are currently mainstream.
With the increase in the number of diabetic patients worldwide, this is an area where technological development is becoming more active.
In recent years, sensors have been inserted subcutaneously to continuously measure glucose concentration in interstitial fluid rather than blood.
Devices that can display (common name: glucose monitor system)
There is active research into non-invasive blood glucose measuring devices that do not require needles, using mid-infrared lasers, etc.
It seems that various companies are conducting research to achieve more accurate tracking while reducing the burden on patients.
Here, we introduce blood glucose measuring devices for use in diagnosis and treatment,
In other words, among medical devices that are blood sugar level measuring devices as medical devices,
I would like to take up the "self-testing glucose meter" and give an overview of it.
self-test glucose meter
Self-testing glucose meters are classified as Class III medical devices.
The following "purpose of use or effect" and "definition" are set.
common name | self-test glucose meter |
Classes | Ⅲ |
Purpose of use or effect | Measuring glucose in the blood by self-testing. |
Definition | A device that measures blood glucose or blood ketones for self-testing. Self-testing devices are manufactured for use by the general public at home. |
Although self-testing glucose meters are Class III medical devices,
Basic requirements standards are already in place.
In other words, if the product conforms to this, the certification procedure will be carried out by a third-party certification body.
In addition, if it has the function of measuring other items such as blood ketone bodies in addition to blood glucose,
Items with communication functions for controlling and changing settings, etc.
It is clearly stated that they are not subject to certification standards.
(Yakusho No. 0330 No. 1: March 28, 3)
Basic requirements standards for self-testing glucose meters
The basic requirements standards require compliance with the following main evaluation items and the applicable items of the standard.
[Primary evaluation item]: Evaluate equivalence with existing products
The following evaluation items shall be evaluated according to the standards established by the Director-General of the Pharmaceutical and Environmental Health Bureau of the Ministry of Health, Labor and Welfare.
1 day reproducibility
2-day reproducibility
3 System accuracy
4 Evaluation of hematocrit value
5 Interfering substances
[standard]
JIS C 1010-1 | Safety of electrical equipment for measurement, control and laboratory use - Part 1: General requirements |
IEC 61010-1 | Safety requirements for electrical equipment for measurement, control, and laboratory use — Part 1: General requirements |
JIS C 1010-2-101 | Safety of measurement, control and laboratory electrical equipment - Part 2-101: Specific requirements - In vitro diagnostic medical equipment |
IEC 61010 2 101 | Safety requirements for electrical equipment for measurement, control and laboratory use — Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment |
JIS T 2304:2012 | Medical Device Software - Software Lifecycle Process |
Verification and procedures for handling self-testing glucose meters
If you are considering using a self-testing glucose meter,
It is first necessary to verify that the equipment is likely to comply with the basic requirements standards.
If the requirements are met, third-party certification will be required; if not, an application will be made to the PMDA.
In order to distribute self-testing glucose meters on the market as medical devices,
As a Class III medical device, it is necessary to obtain medical device certification/approval.
Even if the self-testing glucose meter is manufactured overseas,
This procedure must be completed before importing.
Furthermore, before applying for the above certification/approval, please check the manufacturing factory, importing distributor, and storage factory.
It is also important to note that a medical device manufacturing and sales business license and medical device manufacturing business registration are required.
Permits required to manufacture and sell self-testing glucose meters in Japan
Manufacturer | Class 1 medical device manufacturing and sales business |
Domestic manufacturing factory | Medical device manufacturing industry registration |
Wholesale store/Retail store | Managed medical equipment sales/rental notification |
Permits required when importing and selling self-testing glucose meters manufactured overseas in Japan
Import distributor | Class 1 medical device manufacturing and sales business |
Overseas manufacturing factory | Medical device foreign manufacturer registration |
Domestic storage factory | Medical device manufacturing industry registration |
Wholesale store/Retail store | Managed medical equipment sales/rental notification |
In order to obtain a medical device manufacturing and sales license and manufacturing industry registration,
It is necessary to secure a responsible person with academic background and experience in quality assurance work, etc.
It is necessary to prepare a management system called Quality Management System, which is equivalent to ISO.
The system is quite difficult for new entrants.
