Committee
TC11
Schedule
2022
Prepared By
Stage
FDS
Deadline
31/01/2023

Arabic Title

معايير تصنيف الأجهزة والمستلزمات الطبية

English Title

Medical devices and supplies classification criteria

Category

قطاع الصحة Health Sector

Scope

This standard is related to the classification of medical devices, by setting a Classification rules to decide whether the product is a medical device or not .Where there exists a difficulty in the uniform application of the classification rules; examples highlighted in the annexure of this standard can facilitate the decision of implementing the classification rules of medical devices which may assist in creating a consistency in the classification method and decisions. This standards does not cover borderline products or combination products.

Purpose & Justification

الحاجة لها

Type

Translate

Stanadard No

GSO 2628:2021

References

GSO 2628:2021

Submitted By

Ali AlGhasra علي الغسرة  12/01/2022