Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:5:p27
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 5 (pt 27/30)
Character Range: 204104–206949

Subject to subregulations (3) and (4), the amendments made by Part 2 of Schedule 1 to the 2015 Amendment Regulations apply in relation to the device for all purposes, on and after 1 July 2017.
 (3) If, before the commencement day, the manufacturer of the device has notified the Secretary of the matters referred to in subclause 1.2(1) of Part 6A of Schedule 3 (as inserted by Schedule 1 to the 2010 Amendment Regulations), the manufacturer is taken to have complied with the notification requirements in subclauses 6A.2(1) and (2) and paragraph (3)(a) of Part 6A of Schedule 3 in relation to the devices covered by the notification.
 (4) If:
 (a) on or after the commencement day and before 1 July 2017, the manufacturer of the device notifies the Secretary of the Class 1, 2 or 3 in‑house IVD medical devices being manufactured; and
 (b) the notification is in accordance with subclauses 6A.2(2) and (3) of Part 6A of Schedule 3;
the manufacturer is taken to have complied with the notification requirements in subclauses 6A.2(1) and (2) and paragraph (3)(a) of Part 6A of Schedule 3 in relation to the devices covered by the notification.

Division 11.4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016

11.27  Application
 (1) The amendments made by items 1, 12 and 13 of Schedule 3 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to medical devices included in the Register on or after the day that Schedule commences if the application for inclusion in the Register was made on or after that day.

Division 11.5—Transitional provisions relating to the Therapeutic Goods (Medical Devices) Amendment (Implantable Medical Devices) Regulations 2017

11.28  Definitions
  In this Division:
amending regulations means the Therapeutic Goods (Medical Devices) Amendment (Implantable Medical Devices) Regulations 2017.
finally determined has the meaning given by subregulation 11.29(5).
inclusion day for an entry of a kind of medical device in the Register means the day on which the inclusion of that kind of device in the Register commences.
pre‑commencement entry: an entry of a kind of medical device in the Register is a pre‑commencement entry if that kind of medical device is included in the Register because of an application made before 1 December 2018 (whether the inclusion day for the entry occurred before, on or after 1 December 2018).
unique product identifier, in relation to a medical device, means the unique product identifier given to the device by its manufacturer to identify the device and any variants.

11.29  Surgical mesh—application of amendments

Applications and entries other than pre‑commencement entries
 (1) The amendment made by Part 1 of Schedule 1 to