Commonwealth Consolidated Regulations

THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002

- made under the Therapeutic Goods Act 1989

TABLE OF PROVISIONS

   PART 1--PRELIMINARY

   1.1.    Name of Regulations [see Note 1]  
   1.2.    Commencement [see Note 1]  
   1.3.    Definitions -- the dictionary etc  
   1.4.    Medical devices with a measuring function  
   1.5.    Refurbishment (Act s 3 (1))  
   1.6.    Kinds of medical devices -- other common characteristics (Act s 41BE (1) (e))  
   1.7.    Device nomenclature system codes (Act s 41BE (3))  

   PART 2--ESSENTIAL PRINCIPLES

   2.1.    Essential principles (Act s 41CA)  

   PART 3--CONFORMITY ASSESSMENT PROCEDURES

           Division 3.1--Medical device classifications

   3.1.    Medical device classifications (Act s 41DB)  
   3.2.    Classification of medical devices  
   3.3.    Principles for applying the classification rules  

           Division 3.2--Conformity assessment procedures

   3.4.    Conformity assessment procedures (Act s 41DA)  
   3.5.    Medical devices manufactured outside Australia  
   3.6.    Class III medical devices and Class AIMD medical devices (other than medical devices used for a special purpose)  
   3.6A.   Class 4 IVD medical devices and Class 4 in-house IVD medical devices (other than devices used for 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

   4.1.    When conformity assessment certificates are required (Act s 41EA)  
   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 4.2--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 5--INCLUDING MEDICAL DEVICES IN THE REGISTER

           Division 5.1--Including medical devices in the Register

   5.2.    Matters to be certified -- period for obtaining information from manufacturer (Act s 41FD)  
   5.3.    Applications to be selected for auditing (Act s 41FH)  

           Division 5.2--Conditions

   5.6.    Conditions applying automatically -- period for obtaining information from manufacturer (Act s 41FN)  
   5.7.    Conditions applying automatically -- period for giving information about adverse events etc (Act s 41FN)  
   5.8.    Conditions applying automatically -- requirements in relation to information about kind of medical device (Act s 41FN)  

   PART 6--SUSPENSION AND CANCELLATION FROM THE REGISTER

   6.1.    Period for revocation of suspension (Act s 41GD, s 63 (2) (dd))  

   PART 6A--DISPOSAL OF UNUSED EMERGENCY MEDICAL DEVICES

   6A.1.   Disposal of unused emergency medical devices  

   PART 7--EXEMPTING MEDICAL DEVICES FROM INCLUSION IN THE REGISTER

           Division 7.1--Exempt devices

   7.1.    Exempt devices -- general (Act s 41HA)  
   7.2.    Exempt devices -- use in life-threatening cases (Act s 41HA)  

           Division 7.2--Exemptions for experimental uses

   7.3.    Conditions of approval -- use of device by person to whom approval is given (Act s 41HB)  
   7.4.    Powers of authorised persons in relation to medical devices being used in clinical trials  
   7.5.    Conditions of approval -- use of device by another person (Act s 41HB)  

           Division 7.3--Exemptions for medical practitioners

   7.6.    Classes of medical practitioners and recipients (Act s 41HC)  
   7.7.    Circumstances for supply of device under authority (Act s 41HC)  

   PART 8--OBTAINING INFORMATION

   8.1A.   Matters for which information and documents can be requested  
   8.1.    Notice period (Act s 41JA)  
   8.2.    Exempt devices -- statement by medical practitioner (Act s 41JD)  

   PART 9--FEES

   9.1.    Fees  
   9.2.    Application audit assessment fee (Act ss 41LA, 41LB)  
   9.3.    Conformity assessment fee (Act ss 41LA, 41LB)  
   9.4.    Conformity assessment fee -- abridged assessment  
   9.5.    Payment of assessment fee by instalments (Act s 41LC)  
   9.6.    Reduction of assessment fees  
   9.7.    Reduction of assessment fees -- abridged assessment  

   PART 10--MISCELLANEOUS

   10.1.   Authorised persons  
   10.2.   Information about sponsor  
   10.3.   Custom-made medical devices -- information about manufacturer  
   10.4.   Offences -- period for notifying adverse events (Act s 41MP)  
   10.5.   Delegation -- powers and functions under these Regulations  
   10.6.   Delegation -- powers under paragraph 41HB (1) (d) of the Act  
   10.7.   Review of decisions  
           SCHEDULE 1 Essential principles
           SCHEDULE 2 Classification rules for medical devices other than IVD medical devices
           SCHEDULE 2A Classification rules for IVD medical devices
           SCHEDULE 3 Conformity assessment procedures
           SCHEDULE 3A Disposal of unused emergency medical devices
           SCHEDULE 4 Exempt devices
           SCHEDULE 5 Fees
           DICTIONARY