REGULATION ON TESTING, VERIFICATION AND CALIBRATION

OF MEDICAL DEVICES

CHAPTER I

Purpose, Scope, Grounds & Definitions

Purpose

ARTICLE 1 – (1) This Regulation lays down the rules and procedures for the testing, verification and calibration services required for medical devices to ensure that patients, users and third parties are protected against health and safety hazards that may occur with the use and operation of medical devices as intended.

Scope

ARTICLE 2 – (1) This Regulation covers the rules and procedures applicable to registration, licensing, monitoring and supervision of the entities that will carry out the testing, verification and calibration of medical devices which require specialised user training, and maintenance, repair, testing, verification and calibration routines throughout their use, and the requisite qualifications for personnel to be hired by such entities to undertake and deliver the relevant tasks.