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Determinations/Health as made
This instrument determines the kind and form of information that must accompany an application for a kind of medical device to be included in the Australian Register of Therapeutic Goods.
Administered by: Health
Registered 09 Oct 2018
Tabling HistoryDate
Tabled HR15-Oct-2018
Tabled Senate15-Oct-2018
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018

I, Hongxia Jin, as delegate of the Secretary of the Department of Health, make the following determination.

Dated 5 October 2018         

(Signed by)

Hongxia Jin

Acting 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  Kind of information—medical devices other than IVD medical devices................................... 4

6  Kind of information—IVD medical devices............................................................................. 6

7  Kind of information—medical devices used for a special purpose that are a system or procedure pack 7

8  Alternative kinds of information............................................................................................... 8

9  Classes of medical device for which accompanying information is not determined.................. 9

10  Form of information—all medical devices.............................................................................. 9

Schedule 1— Medical devices other than IVD medical devices      10

Part 1—Class I medical devices                                                                                 10

Part 2—Class IIa medical devices                                                                              14

Part 3—Class IIb medical devices                                                                             19

Part 4—Class III medical devices                                                                              23

Part 5—Class AIMD medical devices                                                                       27

Schedule 2—IVD medical devices                                                    31

Part 1—Class 2 IVD medical devices                                                                        31

Part 2—Class 3 IVD medical devices                                                                        33

Part 3—Class 4 IVD medical devices                                                                        35

Part 4—Class 4 in-house IVD medical devices                                                         36

Schedule 3—Medical devices used for a special purpose that are a system or procedure pack                                                                               37

Part 1—All medical devices used for a special purpose that are a system or procedure pack    37

Part 2—Medical devices used for a special purpose that are a system or procedure pack that are intended to be supplied in a sterile state                                                     38

 

 


1  Name

                   This instrument is the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018.

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

The day after this instrument is registered.

 

 

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 subsections 41FDB(7) and 41FDB(8) of the Act.

4  Definitions

Note:          A number of expressions used in this instrument are defined in section 3 of the Act, including the following:

(a)    conformity assessment certificate;

(b)    conformity assessment document;

(c)    conformity assessment procedures;

(d)    included in the Register;

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

(f)    medical device;

(g)    system or procedure pack.

                   In this instrument:

Act means the Therapeutic Goods Act 1989.

active implantable medical device or AIMD has the same meaning as in the Regulations.

application means an application to the Secretary for a kind of medical device to be included in the Register under section 41FC of the Act.

Canadian medical devices regulations means the Medical Devices Regulations (SOR/98-282) made under the Food and Drugs Act of Canada, as in force immediately before the commencement of this instrument.

certified translation means a translation that contains a statement, dated and signed by a person, to the effect that the translation is a true and complete translation of the accompanying document.

Class 2 IVD medical device means a medical device that is classified under the Regulations as a Class 2 IVD medical device, other than a medical device used for a special purpose.

Class 3 IVD medical device means a medical device that is classified under the Regulations as a Class 3 IVD medical device, other than a medical device used for a special purpose.

Class 4 IVD medical device means a medical device that is classified under the Regulations as a Class 4 IVD medical device, other than a medical device used for a special purpose.

Class 4 in-house IVD medical device means a medical device that is classified, under the Regulations as a Class 4 in-house IVD medical device, other than a medical device used for a special purpose.

Class I medical device means a medical device that is classified, under the Regulations, as a Class I medical device, other than a medical device used for a special purpose.

Class IIa medical device means a medical device that is classified under the Regulations as a Class IIa medical device, other than a medical device used for a special purpose.

Class IIb medical device means a medical device that is classified under the Regulations as a Class IIb medical device, other than a medical device used for a special purpose.

Class III medical device means a medical device that is classified under the Regulations as a Class III medical device, other than a medical device used for a special purpose.

Class AIMD medical device means a medical device that is classified under the Regulations as a Class AIMD medical device, other than a medical device used for a special purpose.

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 immediately before 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 immediately before the commencement of this instrument.

Directive 98/79/EC means Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, as in force immediately before the commencement of this instrument.

EU IVD regulation means Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices, as in force immediately before the commencement of this instrument.

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 immediately before the commencement of this instrument.

in-house IVD medical device has the same meaning as in the Regulations.

IVD medical device, or in vitro diagnostic medical device, has the same meaning as in the Regulations.

Japanese PMD Act means The Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices of Japan, as in force immediately before the commencement of this instrument.

manufacturing licence has the same meaning as in the Regulations.

MDSAP certificate means a certification document issued by a recognised auditing organisation following the completion of an audit of a manufacturer’s quality management system.

measuring function has the same meaning as in the Regulations.

medical device used for a special purpose has the same meaning as in the Regulations.

NATA has the same meaning as in the Regulations.

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.

quality management system certificate means a certificate that is issued following an assessment of a manufacturer’s quality management system, but does not include a MDSAP certificate.

recognised auditing organisation means an organisation authorised to perform audits under the Medical Device Single Audit Program by the Regulatory Authority Council, in relation to that program, comprising the Australian Therapeutic Goods Administration, the United States Food and Drug Administration, the Brazilian Agência Nacional de Vigilância Sanitária, Health Canada, and Japan’s Ministry of Health, Labour and Welfare and the Japanese Pharmaceuticals and Medical Devices Agency.

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

Therapeutic Goods Administration means that part of the Department known as the Therapeutic Goods Administration.

US FDC Act means the Federal Food, Drug, and Cosmetic Act of the United States, as in force immediately before the commencement of this instrument.

5  Kind of information—medical devices other than IVD medical devices

                   Class I medical devices

             (1)  Subject to section 8, an application for a Class I medical device must be accompanied by the following kind of information:

                     (a)  a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 1 of Schedule 1, which is issued or recognised by the regulatory authority in column 2 of that item; and

                     (b)  a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.

             (2)  To avoid doubt:

                     (a)  an application may be accompanied by more than one document referred to in paragraph (1)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (1)(b) (if any);

                     (b)  a document which accompanies the application in accordance with subsection (1) must relate to the kind of device to which the application relates.

                   Class IIa medical devices

             (3)  Subject to section 8, an application for a Class IIa medical device must be accompanied by the following kind of information:

                     (a)  a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 2 of Schedule 1, which is issued or recognised by the regulatory authority in column 2 of that item; and

                     (b)  a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.

             (4)  To avoid doubt:

                     (a)  an application may be accompanied by more than one document referred to in paragraph (3)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (3)(b) (if any);

                     (b)  a document which accompanies the application in accordance with subsection (3) must relate to the kind of device to which the application relates.

                   Class IIb medical devices

             (5)  Subject to section 8, an application for a Class IIb medical device must be accompanied by the following kind of information:

                     (a)  a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 3 of Schedule 1, which is issued or recognised by the regulatory authority in column 2 of that item; and

                     (b)  a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.

             (6)  To avoid doubt:

                     (a)  an application may be accompanied by more than one document referred to in paragraph (5)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (5)(b) (if any);

                     (b)  a document which accompanies the application in accordance with subsection (5) must relate to the kind of device to which the application relates.

                   Class III medical devices

             (7)  Subject to section 8, an application for a Class III medical device must be accompanied by the following kind of information:

                     (a)  a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 4 of Schedule 1, which is issued or recognised by the regulatory authority in column 2 of that item; and

                     (b)  a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.

             (8)  To avoid doubt:

                     (a)  an application may be accompanied by more than one document referred to in paragraph (7)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (7)(b) (if any);

                     (b)  a document which accompanies the application in accordance with subsection (7) must relate to the kind of device to which the application relates.

                   Class AIMD medical devices

             (9)  Subject to section 8, an application for a Class AIMD medical device must be accompanied by the following kind of information:

                     (a)  a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 5 of Schedule 1, which is issued or recognised by the regulatory authority in column 2 of that item; and

                     (b)  a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.

           (10)  To avoid doubt:

                     (a)  an application may be accompanied by more than one document referred to in paragraph (9)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (9)(b) (if any);

                     (b)  a document which accompanies the application in accordance with subsection (9) must relate to the kind of device to which the application relates.

6  Kind of information—IVD medical devices

                   Class 2 IVD medical devices

             (1)  Subject to section 8, an application for a Class 2 IVD medical device must be accompanied by the following kind of information:

                     (a)  a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 1 of Schedule 2, which is issued or recognised by the regulatory authority in column 2 of that item; and

                     (b)  a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.

             (2)  To avoid doubt:

                     (a)  an application may be accompanied by more than one document referred to in paragraph (1)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (1)(b) (if any);

                     (b)  a document which accompanies the application in accordance with subsection (1) must relate to the kind of device to which the application relates.

                   Class 3 IVD medical devices

             (3)  Subject to section 8, an application for a Class 3 IVD medical device must be accompanied by the following kind of information:

                     (a)  a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 2 of Schedule 2, which is issued or recognised by the regulatory authority in column 2 of that item; and

                     (b)  a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.

             (4)  To avoid doubt:

                     (a)  an application may be accompanied by more than one document referred to in paragraph (3)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (3)(b) (if any);

                     (b)  a document which accompanies the application in accordance with subsection (3) must relate to the kind of device to which the application relates.

                   Class 4 IVD medical devices

             (5)  Subject to section 8, an application for a Class 4 IVD medical device must be accompanied by the following kind of information:

                     (a)  a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 3 of Schedule 2, which is issued or recognised by the regulatory authority in column 2 of that item; and

                     (b)  a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.

             (6)  To avoid doubt:

                     (a)  an application may be accompanied by more than one document referred to in paragraph (5)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (5)(b) (if any);

                     (b)  a document which accompanies the application in accordance with subsection (5) must relate to the kind of device to which the application relates.

                   Class 4 in-house IVD medical devices

             (7)  Subject to section 8, an application for a Class 4 in-house IVD medical device must be accompanied by the following kind of information:

                     (a)  a conformity assessment document or other evidence that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 4 of Schedule 2, which is issued or recognised by the regulatory authority in column 2 of that item; and

                     (b)  a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.

             (8)  To avoid doubt:

                     (a)  an application may be accompanied by more than one document referred to in paragraph (7)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (7)(b) (if any);

                     (b)  a document which accompanies the application in accordance with subsection (7) must relate to the kind of device to which the application relates.

7  Kind of information—medical devices used for a special purpose that are a system or procedure pack

             (1)  An application for a medical device used for a special purpose that is a system or procedure pack, other than a system or procedure pack that is classified under the Regulations as:

(a)         a class I medical device that does not have a measuring function and that the manufacturer intends to be supplied in a non-sterile state; or

(b)   a class 1 IVD medical device;

must be accompanied by the following kind of information:

                     (c)  a declaration of conformity that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 1 of Schedule 3, which is issued or recognised by the regulatory authority in column 2 of that item; and

                     (d)  a conformity assessment document in relation to each medical device contained in the system or procedure pack specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.

Additional information required where the manufacturer intends the medical device used for a special purpose to be supplied in a sterile state

             (2)  An application for a medical device to which subsection (1) applies, and which the manufacturer intends to be supplied in a sterile state, must also be accompanied by the following kind of information:

                     (a)  a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 2 of Schedule 3, which is issued or recognised by the regulatory authority in column 2 of that item; and

                     (b)  a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.

             (3)  To avoid doubt:

                     (a)  an application may be accompanied by more than one document referred to in paragraph (2)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (2)(b) (if any);

                     (b)  a document which accompanies the application in accordance with subsection (2) must relate to the kind of device to which the application relates.

8  Alternative kinds of information

                   Medical devices other than IVD medical devices

(1)   An application for a medical device other than an IVD medical device may instead be accompanied by the kind of information determined under section 5 that relates to an application for a kind of medical device that is classified at a higher level than the medical device concerned.

                   IVD medical devices

(2)   An application for an IVD medical device may instead be accompanied by the kind of information determined under section 6 that relates to an application for a kind of medical device that is classified at a higher level than the medical device concerned.

Note:          The kind of information determined under sections 5 and 6 relate to the minimum conformity assessment procedures that the manufacturer must apply to a kind of device of that classification.

9  Classes of medical device for which accompanying information is not determined

                   To avoid doubt, no kind of information is determined for the purposes of subsection 41FDB(7) for an application in relation to a medical device in one of the following classifications:

                     (a)  a Class I medical device that:

                              (i)  the manufacturer intends to be supplied in a non-sterile state; and

                             (ii)  does not have a measuring function;

                     (b)  a medical device that is intended by the manufacturer to be for export only;

                     (c)  a Class 1 IVD medical device;

                     (d)  an in-house IVD medical device other than a Class 4 in-house IVD medical device.

Note:          In effect, this means that no information must accompany applications in relation to these classifications.

10  Form of information—all medical devices

                   All information that accompanies an application in accordance with section 5, 6 or 7 must be:

                     (a)  legible; and

                     (b)  either of the following:

                              (i)  in English; or

                             (ii)  if it is not in English—be accompanied by a certified translation into English.


 

Schedule 1 Medical devices other than IVD medical devices

Note:       See section 5.

Part 1—Class I medical devices

Column 1

Item

Column 2

Regulatory authority

Column 3

Conformity assessment document relating to manufacturer’s quality management system

Column 4

Conformity assessment document relating to product assessment

1

Therapeutic Goods Administration

a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in one of the following Parts of Schedule 3 to the Regulations:

(a)    for a medical device that the manufacturer intends to be supplied in a sterile state (whether or not it has a measuring function):

(i)   Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part; or

(ii)  Part 4 (production quality assurance procedures);

(b)    for a medical device that has a measuring function (and that the manufacturer intends to be supplied in a non-sterile state):

(i)   Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part;

(ii)  Part 3 (verification procedures);

(iii) Part 4 (production quality assurance procedures); or

(iv) Part 5 (product quality assurance procedures)

 

2

a notified body within the meaning of Council Directive 93/42/EEC

 

(a)    for a medical device that the manufacturer intends to be supplied in a sterile state (whether or not it has a measuring function), either of the following:

(i)    a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Part; or

(ii)   a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC;

(b)    for a medical device that has a measuring function (and that the manufacturer intends to be supplied in a non-sterile state), one of the following:

(i)   a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Part;

(ii)  an EC verification certificate issued under Annex IV of Council Directive 93/42/EEC;

(iii) a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC; or

(iv) a product quality assurance certificate or other document issued under Annex VI of Council Directive 93/42/EEC

 

3

a notified body within the meaning of Council Directive 90/385/EEC

(a)    for a medical device that the manufacturer intends to be supplied in a sterile state (whether or not it has a measuring function), either of the following:

(i)   a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC; or

(ii)  an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC;

(b)    for a medical device that has a measuring function (and that the manufacturer intends to be supplied in a non-sterile state), one of the following:

(i)   a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC;

(ii)  an EC verification certificate issued under Annex 4 of Council Directive 90/385/EEC; or

(iii) an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC

 

4

a notified body within the meaning of the EU medical devices regulation

for a medical device that the manufacturer intends to be supplied in a sterile state and/or that has a measuring function, either of the following:

(a)    an EU quality management system certificate issued under Chapter I of Annex IX of the EU medical devices regulation; or

(b)    a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation

 

5

recognised auditing organisation

 

for a medical device that the manufacturer intends to be supplied in a sterile state and/or that has a measuring function¾
a MDSAP certificate

 


 

 

Part 2—Class IIa medical devices

Column 1

Item

Column 2

Regulatory authority

Column 3

Conformity assessment document relating to manufacturer’s quality management system

Column 4

Conformity assessment document relating to product assessment

1

Therapeutic Goods Administration

a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in one of the following Parts of Schedule 3 to the Regulations:

(a)    for a medical device that the manufacturer intends to be supplied in a sterile state:

(i)   Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part; or

(ii)  Part 4 (production quality assurance procedures);

(b)    for a medical device that the manufacturer intends to be supplied in a non-sterile state:

(i)   Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part;

(ii)  Part 3 (verification procedures);

(iii)Part 4 (production quality assurance procedures); or

(iv)Part 5 (product quality assurance procedures)

 

2

a notified body within the meaning of Council Directive 93/42/EEC

 

(a)    for a medical device that the manufacturer intends to be supplied in a sterile state, either of the following:

(i)       a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Part; or

(ii)   a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC;

(b)    for a medical device that the manufacturer intends to be supplied in a non-sterile state, one of the following:

(i)       a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Part;

(ii)   an EC verification certificate issued under Annex IV of Council Directive 93/42/EEC;

(iii) a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC; or

(iv) a product quality assurance certificate or other document issued under Annex VI of Council Directive 93/42/EEC

 

3

a notified body within the meaning of Council Directive 90/385/EEC

(a)     for a medical device that the manufacturer intends to be supplied in a sterile state, either of the following:

(i)       a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC; or

(ii)     an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC;

(b)     for a medical device that the manufacturer intends to be supplied in a non-sterile state, one of the following:

(i)       a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC;

(ii)     an EC verification certificate issued under Annex 4 of Council Directive 90/385/EEC; or

(iii)    an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC

 

4

a notified body within the meaning of the EU medical devices regulation

an EU quality management system certificate issued under Chapter I of Annex IX of the EU medical devices regulation

an EU technical documentation assessment certificate issued under Chapter II of Annex IX of the EU medical devices regulation

5

a notified body within the meaning of the EU medical devices regulation

(a)    for a medical device that the manufacturer intends to be supplied in a sterile state:

(i)   a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation;

(b)    for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following:

(i)   a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation; or

(ii)  an EU product verification certificate issued under Part B of Annex XI of the EU medical devices regulation

 

6

Japan’s Ministry
of Health, Labour and Welfare or
the Japanese Pharmaceuticals and Medical Devices Agency

 

either of the following:

(a)     a MDSAP certificate; or

(b)     a quality management system certificate for the purposes of the Japanese PMD Act

either of the following:

(a)     a pre-market certification issued under the Japanese PMD Act; or

(b)     a pre-market approval issued under the Japanese PMD Act

7

Health Canada

either of the following:

(a)     a MDSAP certificate; or

(b)     for an application submitted before 1 January 2019¾ a quality management system certificate for the purposes of the Canadian medical devices regulations

a Class II medical device licence issued under the Canadian medical devices regulations

8

United States
Food and Drug Administration

a MDSAP certificate

either of the following:

(a)     a determination of substantial equivalence made with respect to a notification submitted under section 510(k) of the US FDC Act; or

(b)     an order granting a request for classification under section 513 of the US FDC Act (a De Novo classification request)

 


 

 

Part 3—Class IIb medical devices

Column 1 Item

Column 2

Regulatory authority

Column 3

Conformity assessment document relating to manufacturer’s quality management system

Column 4

Conformity assessment document relating to product assessment

1

Therapeutic Goods Administration

a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 1 of Schedule 3 to the Regulations (full quality assurance procedures), excluding clause 1.6 of that Part

 

2

Therapeutic Goods Administration

a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in one of the following Parts of Schedule 3 to the Regulations:

(a)     for a medical device that the manufacturer intends to be supplied in a sterile state:

(i)    Part 4 (production quality assurance procedures);

(b)     for a medical device that the manufacturer intends to be supplied in a non-sterile state:

(i)       Part 3 (verification procedures);

(ii)     Part 4 (production quality assurance procedures); or

(iii)    Part 5 (product quality assurance procedures)

a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 2 of Schedule 3 to the Regulations (type examination procedures)

3

a notified body within the meaning of Council Directive 93/42/EEC

 

a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Part

 

4

a notified body within the meaning of Council Directive 93/42/EEC

 

(a)     for a medical device that the manufacturer intends to be supplied in a sterile state:

(i)       a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC;

(b)     for a medical device that the manufacturer intends to be supplied in a non-sterile state, one of the following:

(i)       an EC verification certificate issued under Annex IV of Council Directive 93/42/EEC;

(ii)     a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC; or

(iii)    a product quality assurance certificate or other document issued under Annex VI of Council Directive 93/42/EEC

an EC type-examination certificate issued under Annex III of Council Directive 93/42/EEC

5

a notified body within the meaning of Council Directive 90/385/EEC

a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC

 

6

a notified body within the meaning of the EU medical devices regulation

an EU quality management system certificate issued under Chapter I of Annex IX of the EU medical devices regulation

an EU technical documentation assessment certificate issued under chapter II of Annex IX of the EU medical devices regulation

7

a notified body within the meaning of the EU medical devices regulation

(a)    for a medical device that the manufacturer intends to be supplied in a sterile state:

(i)   a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation;

(b)    for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following:

(i)   a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation; or

(ii)  an EU product verification certificate issued under Part B of Annex XI of the EU medical devices regulation

an EU type-examination certificate issued under Annex X of the EU medical devices regulation

8

Japan’s Ministry
of Health, Labour and Welfare or
the Japanese Pharmaceuticals
and Medical Devices Agency

either of the following:

(a)     a MDSAP certificate; or

(b)     a quality management system certificate for the purposes of the Japanese PMD Act

either of the following:

(a)     a pre-market certification  issued under the Japanese PMD Act; or

(b)     a pre-market approval issued under the Japanese PMD Act

9

Health Canada

either of the following:

(a)     a MDSAP certificate; or

(b)     for an application submitted before 1 January 2019¾a quality management system certificate for the purposes of the Canadian medical devices regulations

a Class III medical device licence issued under the Canadian medical devices regulations

10

United States
Food and Drug Administration

a MDSAP certificate

 

one of the following:

(a)       a determination of substantial equivalence made with respect to a notification submitted under section 510(k) of the US FDC Act;

(b)        an order granting a request for classification under section 513 of the US FDC Act (a De Novo classification request); or

(c)        an order approving an application for premarket approval under section 515 of the US FDC Act

11

United States
Food and Drug Administration

an order approving an application for premarket approval under section 515 of the US FDC Act

 

 

 


 

 

Part 4—Class III medical devices

Column 1 Item

Column 2

Regulatory authority

Column 3

Conformity assessment document relating to manufacturer’s quality management system

 

Column 4

Conformity assessment document relating to product assessment

1

Therapeutic Goods Administration

a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 1 of Schedule 3 to the Regulations (full quality assurance procedures), excluding clause 1.6 of that Part

a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in clause 1.6 of Part 1 of Schedule 3 to the Regulations (examination of design)

2

Therapeutic Goods Administration

a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in one of the following Parts of Schedule 3 to the Regulations:

(a)     for a medical device that the manufacturer intends to be supplied in a sterile state:

(i)       Part 4 (production quality assurance procedures);

(b)     for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following:

(i)       Part 3 (verification procedures); or

(ii)     Part 4 (production quality assurance procedures)

a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 2 of Schedule 3 to the Regulations (type examination procedures)

 

3

a notified body within the meaning of Council Directive 93/42/EEC

a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Annex

an EC design-examination certificate issued under section 4 of Annex II of Council Directive 93/42/EEC

4

a notified body within the meaning of Council Directive 93/42/EEC

(a)     for a medical device that the manufacturer intends to be supplied in a sterile state:

(i)       a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC;

(b)     for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following:

(i)       an EC verification certificate issued under Annex IV of Council Directive 93/42/EEC; or

(ii)     a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC

an EC type-examination certificate issued under Annex III of Council Directive 93/42/EEC

5

a notified body within the meaning of Council Directive 90/385/EEC

a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC

an EC design examination certificate issued under section 4 of Annex 2 of Council Directive 90/385/EEC

6

a notified body within the meaning of Council Directive 90/385/EEC

(a)     for a medical device that the manufacturer intends to be supplied in a sterile state:

(i)       an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC;

(b)     for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following:

(i)       an EC verification certificate issued under Annex 4 of Council Directive 90/385/EEC; or

(ii)     an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC

an EC type-examination certificate issued under Annex 3 of Council Directive 90/385/EEC

7

a notified body within the meaning of the EU medical devices regulation

an EU quality management system certificate issued under Chapter I of Annex IX of the EU medical devices regulation

an EU technical documentation assessment certificate issued under Chapter II of Annex IX of the EU medical devices regulation

8

a notified body within the meaning of the EU medical devices regulation

(a)    for a medical device that the manufacturer intends to be supplied in a sterile state:

(i)   a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation;

(b)    for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following:

(i)   a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation; or

(ii)  an EU product verification certificate issued under Part B of Annex XI of the EU medical devices regulation   

an EU type-examination certificate issued under Annex X of the EU medical devices regulation

9

Japan’s Ministry
of Health, Labour and Welfare or
the Japanese Pharmaceuticals
and Medical Devices Agency

either of the following:

(a)     a MDSAP certificate; or

(b)     a quality management system certificate for the purposes of the Japanese PMD Act

a pre-market approval  issued under the Japanese PMD Act

10

Health Canada

either of the following:

(a)     a MDSAP certificate; or

(b)     for an application submitted before 1 January 2019¾a quality management system certificate for the purposes of the Canadian medical devices regulations

a Class IV medical device licence issued under the Canadian medical devices regulations

11

United States
Food and Drug Administration

a MDSAP certificate

 

an order approving an application for premarket approval under section 515 of the US FDC Act

12

United States
Food and Drug Administration

an order approving an application for premarket approval under section 515 of the US FDC Act

 

 


 

 

Part 5—Class AIMD medical devices

Column 1

Item

Column 2

Regulatory authority

Column 3

Conformity assessment document relating to manufacturer’s quality management system

Column 4

Conformity assessment document relating to product assessment

1

Therapeutic Goods Administration

a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 1 of Schedule 3 to the Regulations (full quality assurance procedures), excluding clause 1.6 of that Part

a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in clause 1.6 of Part 1 of Schedule 3 to the Regulations (examination of design)

 

2

Therapeutic Goods Administration

a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in one of the following Parts of Schedule 3 to the Regulations:

(a)     for a medical device that the manufacturer intends to be supplied in a sterile state:

(i)       Part 4 (production quality assurance procedures)

(b)     for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following:

(i)       Part 3 (verification procedures); or

(ii)     Part 4 (production quality assurance procedures)

a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 2 of Schedule 3 to the Regulations (type examination procedures)

 

3

a notified body within the meaning of Council Directive 93/42/EEC

a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Annex

an EC design-examination certificate issued under section 4 of Annex II of Council Directive 93/42/EEC

4

a notified body within the meaning of Council Directive 93/42/EEC

(a)     for a medical device that the manufacturer intends to be supplied in a sterile state:

(i)       a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC;

(b)     for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following:

(i)       an EC verification certificate issued under Annex IV of Council Directive 93/42/EEC; or

(ii)     a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC

an EC type-examination certificate issued under Annex III of Council Directive 93/42/EEC

5

a notified body within the meaning of Council Directive 90/385/EEC

a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC

an EC design examination certificate issued under section 4 of Annex 2 of Council Directive 90/385/EEC

6

a notified body within the meaning of Council Directive 90/385/EEC

(a)     for a medical device that the manufacturer intends to be supplied in a sterile state:

(i)       an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC;

(b)     for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following:

(i)       an EC verification certificate issued under Annex 4 of Council Directive 90/385/EEC; or

(ii)     an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC

an EC type-examination certificate issued under Annex 3 of Council Directive 90/385/EEC

7

a notified body within the meaning of the EU medical devices regulation

an EU quality management system certificate issued under Chapter I of Annex IX of the EU medical devices regulation

an EU technical documentation assessment certificate issued under Chapter II of Annex IX of the EU medical devices regulation

8

a notified body within the meaning of the EU medical devices regulation

(a)    for a medical device that the manufacturer intends to be supplied in a sterile state:

(i)   a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation;

(b)    for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following:

(i)   a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation; or

(ii)  an EU product verification certificate issued under Part B of Annex XI of the EU medical devices regulation

an EU type-examination certificate issued under Annex X of the EU medical devices regulation

9

Japan’s Ministry
of Health, Labour and Welfare or
the Japanese Pharmaceuticals
and Medical Devices Agency

either of the following:

(a)     a MDSAP certificate; or

(b)    a quality management system certificate for the purposes of the Japanese PMD Act

a pre-market approval issued under the Japanese PMD Act

10

Health Canada

either of the following:

(a)     a MDSAP certificate; or

(b)    for an application submitted before 1 January 2019   a quality management system certificate for the purposes of the Canadian medical devices regulations

a Class IV medical device licence issued under the Canadian medical devices regulations

11

United States
Food and Drug Administration

a MDSAP certificate

 

an order approving an application for premarket approval under section 515 of the US FDC Act

12

United States
Food and Drug Administration

an order approving an application for premarket approval under section 515 of the US FDC Act

 


 

 

Schedule 2—IVD medical devices

Note:       See section 6.

Part 1—Class 2 IVD medical devices

Column 1 Item

Column 2

Regulatory authority

Column 3

Conformity assessment document relating to manufacturer’s quality management system

Column 4

Conformity assessment document relating to product assessment

1

Therapeutic Goods Administration

a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in one of the following Parts of Schedule 3 to the Regulations:

(a)     Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part; or

(b)     Part 4 (production quality assurance procedures)

 

2

a notified body within the meaning of Directive 98/79/EC

either of the following:

(a)     a full quality assurance system certificate or other document issued under section 3 of Annex IV of Directive 98/79/EC; or

(b)     a production quality assurance certificate or other document issued under Annex VII of Directive 98/79/EC

 

 

3

a notified body within the meaning of the EU IVD regulation

an EU quality management system certificate issued under Chapter I of Annex IX of the EU IVD regulation

 

4

Health Canada

either of the following:

(a)     a MDSAP certificate; or

(b)     for an application submitted before 1 January 2019¾a quality management system certificate for the purposes of the Canadian medical devices regulations

a Class II medical device licence issued under the Canadian medical devices regulations

5

United States
Food and Drug Administration

a MDSAP certificate

a determination of substantial equivalence made with respect to a notification submitted under section 510(k) of the
US FDC Act

6

Recognised auditing organisation

a MDSAP certificate

 

 

 

 

 

 


 

 

Part 2—Class 3 IVD medical devices

Column 1 Item

Column 2

Regulatory authority

Column 3

Conformity assessment document relating to manufacturer’s quality management system

Column 4

Conformity assessment document relating to product assessment

1

Therapeutic Goods Administration

a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 1 of Schedule 3 to the Regulations (full quality assurance procedures), excluding clause 1.6 of that Part)

 

2

Therapeutic Goods Administration

a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 4 of Schedule 3 to the Regulations (production quality assurance procedures)

a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 2 of Schedule 3 to the Regulations (type examination procedures)

3

a notified body within the meaning of Directive 98/79/EC

a full quality assurance system certificate or other document issued under section 3 of Annex IV of Directive 98/79/EC

 

4

a notified body within the meaning of Directive 98/79/EC

a production quality assurance certificate or other document issued under Annex VII of Directive 98/79/EC

an EC type-examination certificate issued under Annex V of Directive 98/79/EC

5

a notified body within the meaning of the EU IVD regulation

an EU quality management system certificate issued under Chapter I of Annex IX of the EU IVD regulation

 

6

a notified body within the meaning of the EU IVD regulation

an EU production quality assurance certificate issued under Annex XI of the EU IVD regulation, excluding section 5 of that Annex

an EU type-examination certificate issued under Annex X of the EU IVD regulation

7

Health Canada

either of the following:

(a)     a MDSAP certificate; or

(b)     for an application submitted before 1 January 2019¾a quality management system certificate for the purposes of the Canadian medical devices regulations

a Class III medical device licence issued under the Canadian medical devices regulations

8

United States
Food and Drug Administration

a MDSAP certificate

either of the following:

(a)     a determination of substantial equivalence made with respect to a notification submitted under section 510(k) of the US FDC Act; or

(b)     an order approving an application for premarket approval under section 515 of the US FDC Act

9

United States
Food and Drug Administration

an order approving an application for premarket approval under section 515 of the US FDC Act

 

10

recognised auditing organisation

a MDSAP certificate

 

 


 

 

Part 3—Class 4 IVD medical devices

Column 1 Item

Column 2

Regulatory authority

Column 3

Conformity assessment document relating to manufacturer’s quality management system

Column 4

Conformity assessment document relating to product assessment

1

Therapeutic Goods Administration

a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 1 of Schedule 3 to the Regulations (full quality assurance procedures), excluding clause 1.6 of that Part

a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in clause 1.6 of Part 1 of Schedule 3 to the Regulations (examination of design)

2

Therapeutic Goods Administration

a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 4 of Schedule 3 to the Regulations (production quality assurance procedures)

a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 2 of Schedule 3 to the Regulations (type examination procedures)

 


 

 

Part 4—Class 4 in-house IVD medical devices

Column 1 Item

Column 2

Regulatory authority

Column 3

Conformity assessment document or other evidence relating to manufacturer’s quality management system

Column 4

Conformity assessment document relating to product assessment

1

Therapeutic Goods Administration

a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 1 of Schedule 3 to the Regulations (full quality assurance procedures), excluding clause 1.6 of that Part

a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in clause 1.6 of Part 1 of Schedule 3 to the Regulations (examination of design)

2

Therapeutic Goods Administration

a manufacturing licence referred to in subparagraph 6B.3(2)(a)(ii) of Schedule 3 to the Regulations

 

3

Therapeutic Goods Administration

a certificate of accreditation issued by NATA of the kind referred to in subparagraph 6B.3(2)(b)(i) of Schedule 3 to the Regulations

 

 


 

Schedule 3—Medical devices used for a special purpose that are a system or procedure pack

Note:       See section 7.

Part 1—All medical devices used for a special purpose that are a system or procedure pack

Column 1

Item

Column 2

Regulatory authority

Column 3

Declaration of conformity in relation to the system or procedure pack

Column 4

Conformity assessment document in relation to each medical device

1

Therapeutic Goods Administration

a declaration of conformity made by the manufacturer under clause 7.5 of Schedule 3 to the Regulations

a conformity assessment document in relation to each medical device contained in the system or procedure pack

 


 

Part 2—Medical devices used for a special purpose that are a system or procedure pack that are intended to be supplied in a sterile state

Column 1

Item

Column 2

Regulatory authority

Column 3

Conformity assessment document relating to manufacturer’s quality management system

Column 4

Conformity assessment document relating to product assessment

1

Therapeutic Goods Administration

a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in one of the following Parts of Schedule 3 to the Regulations:

(a)    Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part; or

(b)    Part 4 (production quality assurance procedures)

 

2

a notified body within the meaning of Council Directive 93/42/EEC

 

either of the following:

(a)  a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Part; or

(b)  a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC;

 

3

a notified body within the meaning of Council Directive 90/385/EEC

either of the following:

(a)  a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC; or

(b)  an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC;

 

4

a notified body within the meaning of the EU medical devices regulation

either of the following:

(a)    an EU quality management system certificate issued under Chapter I of Annex IX of the EU medical devices regulation; or

(b)    a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation

 

5

recognised auditing organisation

 

a MDSAP certificate