Document ID: chunk:federal_register_of_legislation:C2024C00632:section:41a:p2
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 41A (pt 2/9)
Character Range: 612470–616076

devices
41BEA Excluded purposes
41BF System or procedure packs
41BG Manufacturers of medical devices
41BH Meaning of compliance with essential principles
41BI Meaning of non‑application of conformity assessment procedures
41BIA Meaning of non‑application of overseas requirements comparable to conformity assessment procedures
41BIB Overseas regulators
Division 3—Application provisions
41BJA Application of this Chapter to a biological
41BK Application of the Criminal Code
Part 4‑2—Essential principles and medical device standards
41C What this Part is about
Division 1—Essential principles
41CA Essential principles
Division 2—Medical device standards
41CB Medical device standards
41CC Content of medical device standards
41CD Inconsistencies between medical device standards
Division 3—Database of unique device identifiers of medical devices
41CE Database of unique device identifiers of medical devices
Part 4‑3—Conformity assessment procedures
41D What this Part is about
Division 1—Conformity assessment procedures
41DA Conformity assessment procedures
41DB Medical device classifications
Division 2—Conformity assessment standards
41DC Conformity assessment standards
41DD Content of conformity assessment standards
41DE Inconsistencies between conformity assessment standards
Part 4‑4—Conformity assessment certificates
41E What this Part is about
Division 1—Issuing conformity assessment certificates
41EA When conformity assessment certificates are required
41EB Applications
41EC Considering applications
41ECA Conformity assessment (priority applicant) determinations
41ED Time for making decisions on applications
41EE Procedure following making a decision whether to issue certificate
41EF Duration of certificate
41EG Lapsing of applications
41EH Treating applications as having been refused
41EI Criminal offences for making a false statement
41EIA Civil penalty for making a false statement
Division 2—Conditions
41EJ Automatic conditions on conformity assessment certificates
41EK Conditions imposed when conformity assessment certificates are issued
41EL Conditions imposed after issuing a conformity assessment certificate
Division 3—Suspension of conformity assessment certificates
41EM Suspension of conformity assessment certificates
41EN Notice of proposed suspension
41EO Duration of suspension
41EP Revocation of suspension
41EQ Powers of revocation of conformity assessment certificates unaffected
Division 4—Revocation of conformity assessment certificates
41ER Automatic revocation of conformity assessment certificates
41ES Immediate revocation of conformity assessment certificates
41ET Revocation of conformity assessment certificates after notice of proposed revocation
41EU Limiting revocation of conformity assessment certificates to some medical devices of a particular kind
41EV Publication of revocation etc. of conformity assessment certificates
41EW Date of effect of revocation etc. of conformity assessment certificates
Part 4‑4A—Australian conformity assessment bodies
41EWA Conformity assessment body determinations
41EWB Content of Australian conformity assessment body certificates
41EWC Duration of Australian conformity assessment body certificates
41EWD Record‑keeping
Part 4‑5—Including medical devices in the Register
41F What this Part is about
Division 1—Including medical devices in the Register
41FA What this Division is about
Subdivision A—Applications
41FC Making an application
41FD Matters to be certified
41FDA Basis of certification of conformity assessment procedures
41FDB Preliminary assessment of applications
41FE Criminal offences for