41BA
In forceRequirements for medical devices (Parts 4‑2 and 4‑3)
Volume 2s 41B-Endnotes
Chapter 4Medical devices
Part 4-1Introduction
Division 1Overview of this Chapter
41BA Requirements for medical devices (Parts 4‑2 and 4‑3)
The requirements for medical devices are:
(a)
essential principles (that are about the safety and performance characteristics of medical devices); and
(b)
conformity assessment procedures (that are mainly about the application of quality management systems) or requirements comparable to conformity assessment procedures.
Note:
Medical device standards may be made under Division 2 of Part 4‑2, and conformity assessment standards may be made under Division 2 of Part 4‑3, but they are not requirements.
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