Description
This document provides guidance on regulatory requirements in relation to medical device establishment licence (MDEL), such as when and how to apply for an MDEL, as well as how to maintain it once it is issued.
Resources
| Name | Format | Description | Link |
|---|---|---|---|
| Guidance on Medical Device Establishment Licensing (GUI-0016) - Summary | HTML | Open resource | |
| Guidance on Medical Device Establishment Licensing (GUI-0016) - Summary | HTML | Open resource |