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This document outlines the minimum requirements for medical device testing and calibration facilities in Indonesia across four classes (A, B, C, D). Class A facilities can test and calibrate the largest number and variety of high, medium, and low risk medical devices, including radiation measurement tools. The requirements include the number and types of devices they must be able to test, proficiency testing requirements, and operating a reference laboratory.

Author

Yusuf Umardani

Language

EN