Therapeutic Goods (Medical Devices) Amendment Regulation 2012 (No. 1)1
Select Legislative Instrument 2012 No. 146
I, QUENTIN BRYCE, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulation under the Therapeutic Goods Act 1989.
Dated 28 June 2012
QUENTIN BRYCE
Governor-General
By Her Excellency’s Command
CATHERINE KING
Parliamentary Secretary for Health and Ageing
1 Name of regulation
This regulation is the Therapeutic Goods (Medical Devices) Amendment Regulation 2012 (No. 1).
2 Commencement
This regulation commences on 1 July 2012.
3 Amendment of Therapeutic Goods (Medical Devices) Regulations 2002
Schedule 1 amends the Therapeutic Goods (Medical Devices) Regulations 2002.
Schedule 1 Amendments
(section 3)
[1] After Part 10
insert
Part 11 Transitional relating to 2012 Amendment Regulation
11.1 Certain Class IIb medical devices
(1) This regulation applies to an implantable medical device that is intended by the manufacturer to be any of the following:
(a) a total or partial shoulder joint replacement;
(b) a total or partial hip joint replacement;
(c) a total or partial knee joint replacement.
(2) If an application is made before 1 July 2012 to include a medical device mentioned in subregulation (1) in the Register, but is not finally determined on 1 July 2012, the medical device must be included in the Register as a Class IIb medical device if the application is successful.
(3) If:
(a) a medical device mentioned in subregulation (1) is included in the Register as a Class IIb medical device on or after 1 July 2012; and
(b) an application is made to include the medical device in the Register as a Class III medical device;
no annual charge is payable for inclusion of the medical device in the Register as a Class III medical device until after 30 June 2014.
(4) Regulation 5.3 does not apply to an application mentioned in subregulation (3).
(5) No application fee is payable for an application mentioned in subregulation (3) if the application is made before 1 July 2013.
(6) If a medical device mentioned in subregulation (1) is included in the Register as a Class IIb medical device on 1 July 2014, the inclusion of the medical device in the Register is cancelled on that day, unless:
(a) an application was made before 1 July 2014 for the medical device to be included in the Register as a Class III medical device; and
(b) the Secretary has not decided whether or not to include the medical device in the Register.
(7) If the application mentioned in paragraph (6) (a) is unsuccessful, the inclusion of the Class IIb medical device in the Register is cancelled on the later of 1 July 2014 and the day that notification is given to the applicant that the application was not successful.
(8) In this regulation, an application is finally determined at the first time that both the following conditions are met:
(a) a decision has been made whether or not to grant the application;
(b) there is no longer any possibility of a change in the outcome of the decision.
(9) For paragraph 8 (b), the exercise of a discretion, after the period has ended, to extend a period for seeking review by a court or tribunal of the decision or of starting other proceedings (including appeals) arising out of the application, decision or review is not to be considered.
[2] Schedule 2, paragraph 3.4 (4) (e)
omit
medicine;
insert
medicine; or
[3] Schedule 2, after paragraph 3.4 (4) (e)
insert
(f) to be any of the following:
(i) a total or partial shoulder joint replacement;
(ii) a total or partial hip joint replacement;
(iii) a total or partial knee joint replacement;
Note
1. All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See www.comlaw.gov.au.
