Australia Therapeutic Goods Act 1989 s41EWD: Australian...

What does s41EWD require?

An Australian corporation that is an Australian conformity assessment body, and whose determination requires it to keep records of certification-related activities, must keep those records at all times while it holds that status and for 15 years after it ceases to be such a body. Breach is an offence of 1,200 penalty units, with a 300 penalty unit strict liability offence.

Other controls in Chapter 4 Parts 4-1 to 4-4A: medical device interpretation, essential principles, conformity assessment and certificates – Australia Therapeutic Goods Act 1989

s41EB-41EI Conformity assessment certificate applications: apply on the approved form with the fee, give no false or misleading information, and allow the Secretary's inspection of manufacturing premises, equipment, processes and facilities (including overseas) when required
s41EJ Conformity assessment certificate holders: allow entry, inspection, testing, sampling and recording at any premises dealing with covered devices, produce documents on the devices and quality system, cooperate with reviews, notify planned substantial changes in writing and pay review fees

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The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpoint All Australia Therapeutic Goods Act 1989 controls