CTHIn ForceLegislation
Therapeutic Goods (Medical Devices) Regulations 2002
6B.1Overview
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#### 6B.1 Overview
The conformity assessment procedures set out in this Part provide for the manufacturer of a Class 4 in‑house IVD medical device to do the following:
(a) implement a quality management system for the design, production, packaging, labelling and final inspection of that kind of device;
(b) prepare technical documentation in relation to that kind of device;
(c) establish and keep up‑to‑date a post‑market monitoring, reporting and corrective action system;
(d) make a declaration of conformity in relation to that kind of device;
(e) prepare and keep records in relation to these procedures;
(f) notify the Secretary of the manufacture of certain Class 4 in‑house IVD medical devices.