Item: Medical Device in Iran , Classified Medical Device
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Medical Device in Iran , Classified Medical Device

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Medical Device in Iran , Classified Medical Device

Classification of medical devices based on risk class.

According to international Terms and Conditions, the medical monitoring device is one of the most important prerequisites for regulating the rules, identifying the risk of medical devices and classifying according to their risk. In this article, we review medical device in Iran.

Finally, the development of these rules and regulations is done in accordance with the classification and application of the manufacturer for the devices.

Each country or region defines this classification based on different principles and methods. And legislative institutions may also create and announce more rules and regulations for classification. However, all these rules are based on the following:

The manufacturer’s intended application
The potential for harm to the human body through use and
Characteristics and complexities of medical device design.

For example, The United States Food and Drug Administration (FDA) classifies medical devices by risk class as follows:

The United States Food and Drug Administration (FDA) has created classifications for approximately 1,700 different generic types of medical devices and has categorized them into 16 medical specialties called panels.

Each of these general types of medical devices is assigned to one of three regulatory classes based on the level of control required to ensure the safety and effectiveness of the device.

The three classes and the requirements for them are:

The classification of medical devices depends on the application of the device and the indications for use.

For example, using a scalpel to cut tissue. A subset of the intended application is created to add a more specialized mark to the devices label, such as “to make an incision in the cornea”.

marks for use can be found on the medical device label.

Classification of medical devices in the world

United States

Class I includes the least hazardous devices and Class III includes the most hazardous devices. This classification is related to the American medical device classification.

Europe

In the European Union, this classification is done in 4 classes 1 – 2a – 2b and 3, where the number 1 indicates low risk and the number 3 indicates the highest risk.

Canada

The Canadian Medical Devices Administration is very similar to the EU classification. With the difference that in Canada it is determined from 1 to 4, that is, from the lowest to the highest risk.

While, the risk class of a particular product in the EU is not necessarily the same as the risk class of the same product in Canada.

Classification of medical device in Iran

In Iran, based on the manufacturer’s claim and the field of application of medical device, this classification is done in 4 categories (A – B – C – D). In this classification, A represents the lowest risk and D represents the highest risk.

Risk class table

United States	Canada	European Union	Iran	Risk level
I	1	1	A	low
II	2	2a	B	Low to moderate
II	3	2b	C	Moderate to high
III	4	3	D	High

According to the terms of the “Medical Device Regulations”, it is essential to be aware of the level of risk of medical device, for all legal person and legal entities active in the medical device industry.

These terms include:

The General Administration can act according to the announced instructions to rank the technical officials In order to confirm the appropriateness of their knowledge, experience and ability with their field of work.

All natural and legal persons active in the field of medical devices are obliged to observe the notification instructions and be aware of the level of risk of medical device with regard to activities in the relevant field such as production, import, clearance, export, transportation, warehousing, distribution, supply, purchase and provide after-sales service for medical devices.

The responsibility for establishing, proving and maintaining compliance with the performance and safety requirements of medical device distributed and supplied rests with the manufacturer, importer, legal representative and their technical official.

Medical devices classification in Iran

Clinical chemistry and toxicology devices

Hematology and pathology devices

Immunology and microbiology devices

Anesthesia devices

Cardiology devices

Dental devices

Ear, nose and throat devices

Gastrointestinal and urological devices

General and plastic surgery devices

General hospital devices and personal use

Neurological devices

Maternity devices

Ophthalmic devices

Orthopedic devices

Physiotherapy devices

Radiology devices

Risk definition in medical devices:

Medical devices designed for human applications are used for diagnostic or therapeutic purposes. They may be a tool, a device or a material. In addition, this devices can be used for daily care of the patient as well as for scientific medical purposes.