2. Medical Device Classifications

Surgical Tables - Class A
Kuwait

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

2.1 Preface

Please refer to Section 2.1 of Kuwait's guidebook for "Class A Devices" for a definition of Medical Devices in the country.

2.2 Category Name & Definition

Please refer to Section 2.2 of Kuwait's guidebook for an overview of the 4 classes of Medical Devices along with the definitions of Active Medical Devices and Accessories of Medical Devices.

Specifically for Surgical Tables products, these include:

• Surgical table (could be considered as the main equipment of the category)
• Accessories
• Components

Surgical Tables are defined as Medical Devices as per EU directive 93/42/EEC and we could predict that same classification will apply to Kuwait.

The intended use of all products could be defined as “surgical tables and accessories intended for use during diagnostic examinations or surgical procedures to support and position a patient default”. This intended use clearly answers to the Medical Device definition as per Kuwait’s Ministerial Decree for the Registration and Release of Medical Devices M.D. (13)/2022.

Surgical Tables are considered as Active Medical Devices.

Components and Accessories of surgical tables are defined as Accessories of Medical Device.

Classification rules:

As per Kuwait's Medical Device Regulation, all surgical table products are classified as Class A Medical Devices. 

2.3 Request for Declassification

Please refer to Section 2.3 of Kuwait's guidebook for "Class A Devices" for information about declassification of Medical Devices.

2.4 References

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