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This instrument constitutes a conformity assessment standard for the quality management systems identified and provides an alternative means for manufacturers of medical devices to demonstrate that they have applied those parts of the conformity assessment procedures that relate to implementing and maintaining a quality management system in relation to its manufacture of medical devices.
Administered by: Health
Registered 27 Mar 2019
Tabling HistoryDate
Tabled HR02-Apr-2019
Tabled Senate02-Apr-2019
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019

I, Miranda Lauman, as delegate of the Minister for Health, make the following order.

Dated 26 March 2019

Miranda Lauman

Assistant Secretary

Medical Devices Branch

Health Products Regulation Group

Department of Health

 


Contents

1  Name........................................................................................................................................ 1

2  Commencement........................................................................................................................ 1

3  Authority.................................................................................................................................. 1

4  Definitions................................................................................................................................ 1

5  Conformity assessment standards¾quality management systems........................................... 1

6  Conformity assessment standards¾quality management systems for kinds of medical devices intended to be supplied in a sterile state........................................................................................................................ 2

7  Repeals..................................................................................................................................... 2

Schedule 1—Conformity assessment standards                                                         3

Schedule 2—Conformity assessment standards for medical devices intended to be supplied in a sterile state                                                                                                          4

Schedule 3—Repeals                                                                                                     9

Conformity Assessment Standards Order (Standard for Quality Management Systems and Quality Assurance Techniques) 2008                                                                                                                                  9

 

 


1  Name

                   This instrument is the Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019.

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

1.  The whole of this instrument

31 March 2019.

31 March 2019

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 section 41DC 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:

(a)    conformity assessment procedures;

(b)    kind, in relation to a medical device;

(c)    manufacturer, of a medical device; and

(d)    medical device.

                   In this instrument:

Act means the Therapeutic Goods Act 1989.

ISO means the International Organisation for Standardization.

Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.

standard means a standard published by the ISO, as in force or existing immediately before the commencement of this instrument.

Note:          Standards are published by the ISO at https//www.iso.org.

5  Conformity assessment standards¾quality management systems

             (1)  This section applies in relation to the manufacture of a kind of medical device, whether or not it is intended by the manufacturer to be supplied in a sterile state.

             (2)  The matters specified in a standard, or part of a standard, mentioned in column 2 of an item in the table in Schedule 1 to this instrument constitute a conformity assessment standard for a quality management system mentioned in Part 1, 4 or 5 of Schedule 3 to the Regulations.

             (3)  A quality management system mentioned in Part 1, 4 or 5 of Schedule 3 to the Regulations that complies with a standard, or part of a standard, mentioned in column 2 of an item in the table in Schedule 1 to this instrument is to be treated as having had applied to it those parts of the conformity assessment procedures specified in column 3 of that item.

6  Conformity assessment standards¾quality management systems for kinds of medical devices intended to be supplied in a sterile state

             (1)  This section applies in relation to the manufacture of a kind of medical device that is intended by the manufacturer to be supplied in a sterile state.

             (2)  The matters specified in a standard, or part of a standard, mentioned in column 2 of an item in the table in Schedule 2 to this instrument, when used for a purpose mentioned in column 3 of that item, constitute a conformity assessment standard for a quality management system mentioned in Part 1 or 4 of Schedule 3 to the Regulations.

             (3)  A quality management system mentioned in Part 1 or 4 of Schedule 3 to the Regulations that complies with a standard, or part of a standard, mentioned in column 2 of an item in the table in Schedule 2 to this instrument, when that standard is used for the purpose mentioned in column 3 of that item, is to be treated as having had applied to it those parts of the conformity assessment procedures specified in column 4 of that item.

7  Repeals

                   Each instrument that is specified in Schedule 3 to this instrument is repealed as set out in the applicable items in that Schedule.


 

Schedule 1Conformity assessment standards

Note:       See section 5.

 

Conformity assessment standards for quality management systems

Column 1

Column 2

Column 3

Item

Standard

Conformity assessment procedures

1

ISO 13485:2016 Medical devices¾Quality management systems¾Requirements for regulatory purposes

the conformity assessment procedures set out in clause 1.4 of Part 1 of Schedule 3 to the Regulations

2

ISO 13485:2016 Medical devices¾Quality management systems¾Requirements for regulatory purposes, other than clause 7.3 Design and Development

the conformity assessment procedures set out in clause 4.4 of Part 4 of Schedule 3 to the Regulations

3

ISO 13485:2016 Medical devices¾Quality management systems¾Requirements for regulatory purposes, other than:

(a)     clause 7.3 Design and Development; and

(b)     clause 7.5.6 Validation of processes for production and services provision

the conformity assessment procedures set out in clause 5.4 of Part 5 of Schedule 3 to the Regulations


 

Schedule 2Conformity assessment standards for medical devices intended to be supplied in a sterile state

Note:       See section 6.

 

Conformity assessment standards for quality management systems for kinds of medical devices intended by their manufacturer to be supplied in a sterile state

Column 1

Column 2

Column 3

Column 4

Item

Standard

Purpose

Conformity assessment procedures

1

both of the following:

(a)    ISO 11135:2014 Sterilization of health-care products¾Ethylene oxide¾Requirements for the development, validation and routine control of a sterilization process for medical devices; and

(b)    ISO 11135:2014/Amd 1:2018 Revision of Annex E, Single batch release

for use in the validation and routine control of ethylene oxide sterilization processes for medical devices

(a)     the conformity assessment procedures set out in subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations; and

(b)     the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations

2

all of the following:

(a)    ISO 11137-1:2006 Sterilization of health care products¾Radiation¾
Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices;
and

(b)    ISO 11137-1:2006/Amd 1:2013; and

(c)     ISO 11137-1:2006/Amd 2:2018 Revision to 4.3.4 and 11.2; and

(d)    ISO 11137-2:2013 Sterilization of health care products¾Radiation¾Part 2: Establishing the sterilization dose; and

(e)     ISO 11137-3:2017 Sterilization of health care products¾Radiation¾Part 3: Guidance on dosimetric aspects of development, validation and routine control; and

(f)     ISO/TS 13004:2013 Sterilization of health care products¾Radiation¾
Substantiation of selected sterilization dose: Method VDmaxSD

for use in the validation and routine control of radiation sterilization processes for medical devices

(a)     the conformity assessment procedures set out in subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations; and

(b)     the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations

3

all of the following:

(a)    ISO 13408-1:2008 Aseptic processing of health care products¾Part 1: General requirements; and

(b)    ISO 13408-1:2008/ Amd 1:2013; and

(c)     ISO 13408-2:2018 Aseptic processing of health care products¾Part 2: Sterilizing filtration; and

(d)    ISO 13408-3:2006 Aseptic processing of health care products¾Part 3: Lyophilization; and

(e)     ISO 13408-4:2005 Aseptic processing of health care products¾Part 4: Clean-in-place technologies; and

(f)     ISO 13408-5:2006 Aseptic processing of health care products¾Part 5: Sterilization in place; and

(g)     ISO 13408-6:2005 Aseptic processing of health care products¾Part 6: Isolator systems; and

(h)    ISO 13408-6:2005/Amd 1:2013; and

(i)      ISO 13408-7:2012 Aseptic processing of health care products¾Part 7: Alternative processes for medical devices and combination products

for use in the validation and routine control of aseptic manufacturing processes for medical devices that are not terminally sterilized, including sterilizing filtration, lyophilisation, clean-in-place technologies, sterilization in place, isolator systems and alternative processes for medical devices and combination products

(a)     the conformity assessment procedures set out in subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations; and

(b)     the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations

4

ISO 14160:2011 Sterilization of health care products¾Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives¾Requirements for characterization, development, validation and routine control of a sterilization process for medical devices

for use in the validation and routine control of sterilization processes for medical devices using liquid chemical sterilants

(a)     the conformity assessment procedures set out in subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations; and

(b)     the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations

5

ISO 14937:2009 Sterilization of health care products¾General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

for use in the validation and routine control of a sterilization process for medical devices that is not mentioned in any of the standards specified in items 1 to 4

(a)     the conformity assessment procedures set out in subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations; and

(b)     the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations

6

ISO 17664:2017 Processing of health care products¾
Information to be provided by the medical device manufacturer for the processing of medical devices

for use in circumstances where the manufacturer reasonably considers that a medical device is suitable to be cleaned and
re-sterilized

(a)     the conformity assessment procedures set out in subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations; and

(b)     the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations

7

ISO 17665-1:2006 Sterilization of health care products¾Moist heat¾Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

for use in the validation and routine control of steam sterilization processes

(a)     the conformity assessment procedures set out in subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations; and

(b)       the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations

8

ISO 18362:2016 Manufacture of cell-based health care products¾Control of microbial risks during processing

for use in the validation and routine control of manufacturing processes used for cell-based health care products that are medical devices

(a)     the conformity assessment procedures set out in subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations; and

(b)     the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations

9

ISO 20857:2010 Sterilization of health care products¾Dry heat¾Requirements for the development, validation and routine control of a sterilization process for medical devices

for use in the validation and routine control of dry heat sterilization processes

(a)     the conformity assessment procedures set out in subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations; and

(b)     the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations

10

ISO 25424:2018 Sterilization of health care products¾Low temperature steam and formaldehyde¾Requirements for development, validation and routine control of a sterilization process for medical devices

for use in the validation and routine control of low temperature steam and formaldehyde sterilization processes

(a)     the conformity assessment procedures set out in subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations; and

(b)     the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations

11

both of the following:

(a)    ISO 11607-1:2019 Packaging for terminally sterilized medical devices¾Part 1: Requirements for materials, sterile barrier systems and packaging systems; and

(b)   ISO 11607-2:2019 Packaging for terminally sterilized medical devices¾Part 2: Validation requirements for forming, sealing and assembly processes

for use in the validation and routine control of terminally sterilized medical devices

(a)     the conformity assessment procedures set out in subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations; and

(b)     the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations

Schedule 3Repeals

Conformity Assessment Standards Order (Standard for Quality Management Systems and Quality Assurance Techniques) 2008

1  The whole of the instrument

Repeal the instrument.