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

Australia Therapeutic Goods Act 1989 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

What does s41EJ require?

Every conformity assessment certificate is automatically conditional on the manufacturer allowing an authorised person to enter at a reasonable time any premises (in Australia or overseas) where it or others deal with the covered devices, to inspect premises and devices, examine, measure, test, have tests conducted on and sample devices or related things, and make still or moving images or recordings; producing on request documents about the covered devices or its quality management system and letting them be copied; cooperating in any Secretary review of whether the conformity assessment procedures on quality systems, essential principle certification and other prescribed requirements have been applied; notifying the Secretary in writing of any plan for substantial changes to its quality management systems, the product range they cover or the design of covered devices; and paying the prescribed review fee. Regulations add conditions (for example the poisons condition in regulation 4.3G), and breach can lead to suspension or revocation.

Maintained by Gerard Blokdyk

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

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