Document ID: chunk:federal_register_of_legislation:C2024C00632:section:41a:p4
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 41A (pt 4/9)
Character Range: 618729–621911

of exemption
41GV Informing persons of exemption etc.
41GW Notification and tabling
41GY Disposal of unused medical devices
Part 4‑7—Other exemptions from including medical devices in the Register
41H What this Part is about
41HA Devices exempted from inclusion in the Register
41HB Approvals for special and experimental uses
41HC Authorities for health practitioners
41HD Approvals if substitutes for medical devices are unavailable or in short supply
Part 4‑8—Obtaining information
41J What this Part is about
Division 1—Information relating to compliance with requirements and other matters
41JA Secretary may require information or documents
41JB Complying with the Secretary's requirements
41JBA Civil penalty for giving false or misleading information in purported compliance with a notice
41JC Self‑incrimination
Division 2—Information relating to medical devices covered by exemptions
41JCA Secretary may require information etc. about medical devices exempt under Part 4‑6A
41JD Secretary may require information etc. about devices exempted under section 41HA from inclusion in the Register
41JE Secretary may require information relating to approvals under section 41HB
41JF Secretary may require information relating to health practitioner authorisations
41JFA Secretary may require information relating to approvals under section 41HD
41JG Criminal offences for failing to give information or documents sought under this Division
41JH False or misleading information
41JI False or misleading documents
41JJ Self‑incrimination
Part 4‑9—Public notification, and recall, of medical devices
41K What this Part is about
41KA Public notification, and recall, of medical devices
41KB Publication of requirements
41KC Criminal offences for failing to comply with requirements relating to a kind of medical device
41KCA Civil penalty for failing to comply with requirements relating to a kind of medical device
41KD Powers of suspension and cancellation unaffected
41KE Saving of other laws
Part 4‑10—Assessment fees
41L What this Part is about
41LA Assessment fees
41LB When assessment fee due for payment
41LC Payment of assessment fee by instalments
41LD Recovery of assessment fee
41LE Reduction of conformity assessment fee where decision not made within prescribed period
Part 4‑11—Offences and civil penalty provisions relating to medical devices
41M What this Part is about
Division 1—Non‑compliance with essential principles
41MA Criminal offences for importing, supplying or exporting a medical device that does not comply with essential principles
41MAA Civil penalties for importing, supplying or exporting a medical device that does not comply with essential principles
41MB Exceptions
41MC Criminal offences relating to breaching a condition of a consent
41MCA Civil penalty relating to breaching a condition of a consent
41MD Treating medical devices as prohibited imports or exports
Division 2—Failure to apply conformity assessment procedures
41ME Criminal offences for failing to apply conformity assessment procedures—manufacturers
41MEA Civil penalties for failing to apply conformity assessment procedures—manufacturers
41MF Criminal offences for failing to