2. Medical Device Classifications

Medical Devices - Class A
Kuwait

This section provides the regulatory classification of the medical devices in scope.

2.1 Preface

The Ministerial Decree for the Registration and Release of Medical Devices M.D. (13)/2022 defines what is a Medical Device. Below is an extract, Definition of a Medical Device:

2.2 Class Name & Definition

Kuwait uses a risk-based classification system for medical devices. The level of regulatory control applied to the medical device is proportional to the degree of perceived risk associated with the device. The requirements of the review process differ for each class, type, and technology of medical device.

Medical devices may be classified into four classes, A-D, with Class A being the lowest risk and Class D being the highest risk. These classes correspond closely to the four risk classes used in Europe (Class I, Class IIa, Class IIb, and Class III). 

• Bandages and tongue depressors are examples of low-risk, Class A devices.
• Hypodermic needles and suction equipment are examples of low/moderate risk, Class B devices.
• Lung ventilators/bone fixation plates are examples of moderate/high-risk Class C devices.
• Heart valves/implantable defibrillators are examples of high-risk Class D devices. 

The manufacturer should document the justification for placing a device into a particular product class. 

An accessory to a medical device may be classified separately from the main device. Where one medical device is intended to be used together with a different medical device, which may or may not be from the same manufacturer (e.g. pulse oximeter and a replaceable sensor sourced from a different manufacturer, or a general-purpose syringe and a syringe driver), the classification rules should apply separately to each of the devices.

Active Medical Devices

Following Kuwait’s Ministerial Decree for the Registration and Release of Medical Devices M.D. (13)/2022, the following definition of Active Medical Devices is provided:

Accessories of Medical Devices

Accessories and components are parts that could be sold or distributed alone. Following Kuwait’s Ministerial Decree for the Registration and Release of Medical Devices M.D. (13)/2022, the following definition of Accessories of Medical Devices is provided:

2.3 Request for Declassification

Health Authorities are entitled to publish declassification rules for low-risk products. For example, UK's MHRA, US's FDA, and Singapore's MoH have all declassified general wellness software as non-medical devices as per documented and public declassification rules. Unfortunately, no documented declassification rules are published in Kuwait. 

It also happens that a Health Authority and/or its employees do not strictly follow the regulations and decide to de-classify low-risk products under their own interpretation. Such an event can happen but a documented exchange/confirmation from the MoH shall be recorded as evidence of authorization.

2.4 References

1. MINISTERIAL DECREE FOR REGISTRATION AND RELEASE OF MEDICAL DEVICES M.D. ( 13 ) I 2022