41F
CurrentWhat this Part is about
Volume 2s 41B-Endnotes
Chapter 4Medical devices
Part 4-5Including medical devices in the Register
41F What this Part is about
Kinds of medical devices can be included in the Register if they comply with the essential principles, and conformity assessment procedures have been applied to the kinds of devices or requirements, comparable to those procedures, have been applied to the kinds of devices (and certain other requirements are complied with).
Inclusions in the Register are subject to certain automatic conditions and the Secretary may impose further conditions.
This Act’s bill:Second reading speech
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