Document ID: chunk:federal_register_of_legislation:F2025C00021:front:0:p2
Version: federal_register_of_legislation:F2025C00021
Segment Type: other
Provision Reference: 
Character Range: 2812–6125

devices used for a special purpose)
3.6A Class 4 IVD medical devices (other than medical devices to be used for a special purpose)
3.6B Class 4 in‑house IVD medical devices (other than medical devices to be used for a special purpose)
3.7 Class IIb medical devices (other than medical devices used for a special purpose)
3.7A Class 3 IVD medical devices (other than devices to be used for a special purpose)
3.7B Class 3 in‑house IVD medical devices
3.8 Class IIa medical devices (other than medical devices used for a special purpose)
3.8A Class 2 IVD medical devices (other than devices to be used for a special purpose)
3.8B Class 2 in‑house IVD medical devices
3.9 Class I medical devices (other than medical devices used for a special purpose)
3.9A Class 1 IVD medical devices (other than devices to be used for a special purpose)
3.9B Class 1 in‑house IVD medical devices
3.10 Medical devices used for a special purpose
3.11 Medical devices to which the clinical evaluation procedures must be applied
3.12 Records to be provided in English
3.13 Assessment or verification at intermediate stage of manufacture
Part 4—Conformity assessment certificates
Division 4.1—Issuing conformity assessment certificates
4.2 Considering applications for conformity assessment certificates (Act s 41EC)
4.3 Time for making decision on applications (Act s 41ED, s 63(2)(dc))
Division 4.1A—Conformity assessment (priority applicant) determinations
4.3A Application of Division
4.3B Application for conformity assessment (priority applicant) determination
4.3C Making of conformity assessment (priority applicant) determination
4.3D Period during which conformity assessment (priority applicant) determination is in force
4.3E Revocation of conformity assessment (priority applicant) determination
Division 4.1B—Content of conformity assessment certificates
4.3F Content of conformity assessment certificates
Division 4.1C—Conditions
4.3G Conditions applying automatically—information about poisons
Division 4.2—Suspension of conformity assessment certificates
4.4 Period for revocation of suspension (Act s 41EP, s 63(2)(db))
Division 4.3—Transfer of conformity assessment certificates
4.5 Application of Division 4.3
4.6 Death, bankruptcy or winding up of manufacturer
4.7 Disposal of business or amalgamation with another manufacturer
4.8 Change of name of manufacturer
4.9 Effect of conformity assessment certificate after transfer, etc
4.10 Notification to Secretary of events
4.11 Notification of change of name or suspension or revocation of conformity assessment certificate
Part 4A—Australian conformity assessment bodies
Division 4A.1—Preliminary
4A.1 Purposes of this Part
Division 4A.2—Making conformity assessment body determinations
4A.2 Applications
4A.3 Further information
4A.4 Documents to be provided in English
4A.5 Lapsing of applications
4A.6 Assessing applications
4A.7 Procedure following decisions to make determinations
4A.8 Duration of determinations
4A.9 Procedure following decisions not to make determinations
Division 4A.3—Conditions on conformity assessment body determinations
Subdivision A—Automatic conditions on determinations
4A.10 Automatic conditions on determinations
4A.11 Conditions—requirements of Schedule 3AA
4A.12 Conditions—notifying Secretary and clients
4A.13 Conditions—entry