Section 1 - Therapeutic Goods (Transition to EU Medical Devices Regulation) (Information) Specification 2022 - Therapeutic Goods (Transition to EU Medical Devices Regulation) (Information) Specification 2022 | Zoe
Therapeutic Goods (Transition to EU Medical Devices Regulation) (Information) Specification 2022
1Therapeutic Goods (Transition to EU Medical Devices Regulation) (Information) Specification 2022
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Therapeutic Goods (Transition to EU Medical Devices Regulation) (Information) Specification 2022
I, Tracey Duffy, as delegate of the Minister for Health and Aged Care, make the following specification.
Dated 28 November 2022
Tracey Duffy
First Assistant Secretary Medical Devices and Product Quality Division Health Products Regulation Group Department of Health and Aged Care
Contents
1 Name
2 Commencement
3 Authority
4 Definitions
5 Release of therapeutic goods information
6 Repeals
Schedule 1—Therapeutic goods information
Schedule 2—Repeals
Therapeutic Goods (Transition to EU Medical Devices Regulation—Stakeholder Testing) (Information) Specification 2022
1 Name
This instrument is the Therapeutic Goods (Transition to EU Medical Devices Regulation) (Information) Specification 2022.
2 Commencement
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
Commencement information
Column 1 Column 2 Column 3
Provisions Commencement Date/Details
The whole of this instrument 5 December 2022. 5 December 2022
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
3 Authority
This instrument is made under subsection 61(5D) of the Therapeutic Goods Act 1989.
4 Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
Council Directive 90/385/EEC means Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC) of the Council of the European Communities, as in force or existing at the commencement of this instrument.
Council Directive 93/42/EEC means Council Directive 93/42/EEC of 14 June 1993 concerning medical devices of the Council of the European Communities, as in force or existing at the commencement of this instrument.
EU MDD certificate means an overseas regulator conformity assessment document that is issued by a notified body under Council Directive 93/42/EEC or Council Directive 90/385/EEC.
EU MDR certificate means an overseas regulator conformity assessment document that is issued by a notified body under the EU medical devices regulation.
EU medical devices regulation means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, as in force or existing at the commencement of this instrument.
GMDN Agency means the not-for-profit organisation, registered in the United Kingdom, responsible for the Global Medical Device Nomenclature system.
GMDN code, or Global Medical Device Nomenclature code, means the 5-digit numeric code assigned to all medical devices under the Global Medical Device Nomenclature system maintained by the GMDN Agency.
GS1 means the not-for-profit standards organisation known as GS1 that has its headquarters in Belgium.
GTIN, or Global Trade Item Number, means the GS1 identification key used to identify trade items.
Note: A GTIN comprises a GS1 company prefix, an item reference and a check digit.
instructions for use has the same meaning as in the Medical Devices Regulations.
intended purpose has the same meaning as in the Medical Devices Regulations.
Medical Devices Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.
notified body means a body that has been designated by a member state of the European Union, and notified to the European Commission, to assess the conformity of medical devices, including in vitro diagnostic medical devices and active implantable medical devices.
online notification form means the online form Form: Sponsor notification for medical devices transitioning from the EU MDD to the EU MDR, which relates to the provision of information about a relevant kind of medical device and its transition, accessed via the TGA – Citizen Space website at https://consultations.tga.gov.au/tga/ef19f496/, as in force or existing at the commencement of this instrument.
relevant kind of medical device means a kind of medical device that is included in the Register and for which certification of the matter referred to in paragraph 41FD(f) of the Act is based on an EU MDD certificate.
Therapeutic Goods Administration, or TGA, means that part of the Department known as the Therapeutic Goods Administration.
therapeutic goods information has the meaning given by subsection 61(1) of the Act.
transition, in relation to a relevant kind of medical device, means transition from an EU MDD certificate to an EU MDR certificate that applies to the kind of device.
5 Release of therapeutic goods information
The kinds of therapeutic goods information set out in the table in Schedule 1 are specified for the purposes of subsection 61(5C) of the Act.
Note: Kinds of therapeutic goods information specified under subsection 61(5D) of the Act may be released by the Secretary to the public under subsection 61(5C) of the Act.
6 Repeals
Each instrument that is specified in Schedule 2 is repealed as set out in the applicable items in that Schedule.
Schedule 1—Therapeutic goods information
Note: See section 5.
Specified kinds of therapeutic goods information
Column 1 Column 2
Item Kinds of Information
1 the following information provided by a sponsor (or a person authorised to act on behalf of a sponsor) in the online notification form in relation to the transition of a relevant kind of medical device, as applicable:(a) the manufacturer’s name;(b) the sponsor’s name;(c) contact details for enquiries;(d) the name of the kind of medical device affected by the transition;(e) the device number;(f) the GMDN code;(g) the GTIN;(h) the intended purpose;(i) the date of effect of the EU MDR certificate;(j) details of changes in relation to any of the following matters relating to the kind of medical device as a result of the transition (that is, details under the EU MDD certificate, details under the EU MDR certificate and products affected):(i) indications in the instructions for use;(ii) class of persons for which the device is suitable;(iii) intended purpose;(iv) functional description;(v) addition of a warning for a novel or newly identified safety issue or contraindication;(vi) addition of adverse event information that would change patient management recommendations
2 the following dates in relation to the information mentioned in item 1:(a) the date the online notification form is submitted;(b) the date of release of that information by the TGA
Schedule 2—Repeals
Note: See section 6.
Therapeutic Goods (Transition to EU Medical Devices Regulation—Stakeholder Testing) (Information) Specification 2022