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Essential Principles - consent for noncompliance
- Australian regulatory guidelines for medical devices (ARGMD)
see Part 1, Section 3
There are Criminal Offences under S41MA and Civil Penalties under S41MAA of the Therapeutic Goods Act 1989, for persons who import, supply or export medical devices that do not meet the Essential Principles for safety and performance.
However there may be extenuating circumstances preventing compliance to one or more parts of an Essential Principle for a limited period of time.
In such circumstances sponsors may request consent to import, supply or export medical devices which do not meet an Essential Principle.