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Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)

For abridgement of TGA conformity assessments and as information required for applications for ARTG inclusion

26 July 2019

The purpose of this guidance is to help manufacturers and sponsors understand how the TGA interprets regulations, and thus indicate how a manufacturer/sponsor can comply.

This is a guide only, and manufacturers and sponsors are encouraged to familiarise themselves with the legislative and regulatory requirements in Australia. If necessary, seek professional advice as it is the responsibility of each manufacturer or sponsor to understand and comply with these requirements.

This document will evolve over time and updates and clarifications will be included as required. Feedback on the guidance is always welcome.

Introduction

One of the recommendations accepted by the Australian Government from the Expert Panel Review of Medicines and Medical Devices Regulation (the Review) was a better utilisation of marketing approvals of medical devices, including IVD medical devices, where the device has been:

  • conformity assessed by a body that has been designated to undertake conformity assessments by a comparable overseas designating authority; or
  • approved by a comparable overseas national regulatory authority.

Please note

The Australian Government also accepted the Review recommendation that TGA retain responsibility for making decisions regarding market authorisation of therapeutic goods in Australia.

The TGA will continue to assess applications for conformity assessment certificates for some devices and for the inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG).

This guidance

The purpose of this document is to provide an overview of how specific overseas assessments and approvals can be used by applicants for the purposes of supporting the basis for a possible abridged assessment of an application for a TGA conformity assessment certificate, or as the documentation required to be provided with applications for inclusion of medical devices (including IVDs) in the ARTG.

Please note

These arrangements are prescribed by the following instruments:

In case of any inconsistencies between instruments (including future amendments) and this guidance, the instruments are in force and should be followed.

Overseas evidence that can be considered

Specific evidence and documentation, issued by specific overseas regulators and assessment bodies, will be considered by the TGA in relation to requests for abridgement of TGA conformity assessments or as the documentation required for applications for inclusion of medical devices in the ARTG:

  • Certificates issued by Notified Bodies designated by the medical device regulators of European member states, under the medical device regulatory frameworks of the European Union (Medical devices directives[1], Medical Device Regulation, or IVD Regulation)
  • Decisions of the United States Food and Drug Administration (FDA)
  • Approvals and licences issued by Health Canada
  • Pre-market approvals from Japan (issued by the Ministry of Health, Labour and Welfare (MHLW), Pharmaceutical and Medical Devices Agency (PMDA) or Registered Certified Body (RCB), whatever is applicable)
  • Certificates and reports issued under the Medical Device Single Audit Program (MDSAP)*.
  • ISO 13485:2016 certificates issued by a certification body that is also a Notified Body designated under the IVDD 98/79/EC (for IVD inclusion applications only until 26 May 2022)
  • ISO 13485:2016 certificates issued by a body that is an accredited body that is a signatory to the Multilateral Recognition Arrangement of the International Accreditation Forum (IAF MLA) (for IVD inclusion applications only until 26 May 2022)

* For MDSAP certificates and audit reports to be considered, the Australian regulatory requirements must have been covered in the audit(s), and certificates must show that the manufacturer has been assessed and found to comply with the relevant aspects of the Therapeutic Goods (Medical Devices) Regulations 2002

The documentation should be issued by an overseas regulator or assessment body for the same medical device as you are applying for in Australia with:

  • the same design
  • the same intended purpose, and
  • intended for the same indications.

Table1 and Table 2 in this guidance specify what documentation can be utilised for what purpose:

Application requirements

Please note

Apart from the ability to use a broader range of overseas assessments and approvals in support of applications, there is no other change to existing regulatory requirements for safety, quality, and performance of medical devices authorised for supply in Australia, and no change to the TGA's existing regulatory requirements and processes.

Reduction of assessment fees for medical devices

Guidance is available which outlines where assessment fees administered by the TGA can be reduced for both application audit assessments, and conformity assessments involving medical devices (including IVDs).

Please see: Reduction of assessment fees for medical devices which provides additional information about the eligibility requirements and procedures used by the TGA.

How to use this section

To best describe how specified overseas evidence should be used the application requirements are divided into two parts:

Part A - Abridgement of TGA conformity assessment

Evidence of conformity assessment needs to demonstrate that a manufacturer's quality management system meets certain regulatory requirements, and that their devices comply with the relevant essential principles. An acceptable overseas audit report or product evaluation report may contain information that will help to demonstrate that these requirements are met.

For the possible abridgement of an assessment of a TGA conformity assessment application, you may provide certain documents from specified overseas assessment bodies to facilitate the TGA's overall conformity assessment evaluation process. This will result in the TGA being able to reduce the amount of assessment that it must undertake on a particular application.

Requirements when relying on overseas approvals or assessments

Table 1 outlines the documents that can be provided against the relevant conformity assessment procedures. This also includes reference to MDSAP reports, which can also be considered when assessing a conformity assessment application.

How to use Table 1

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Application for a:

  • Part 1 Full Quality Management System (QMS) certificate for a manufacturer of medical devices
    • Requires a Design and Production QMS assessment
    • The manufacturer has an EU Medical Device Directive (MDD) Full Quality Assurance (FQA) audit report
    • The FQA audit report is an initial audit report that covers the same manufacturing sites and device categories as your application.
screenshot of table - Part 1 - Full QMS with 'EU MDD/IVDD/AIMDD Full Quality Assurance (FQA) Audit Report' highlighted under column 'Initial audit'

You may provide the FQA audit report to the TGA with the supporting documentation for the application.

If a sufficiently detailed report is provided, then we may be able reduce the assessment by undertaking a desk assessment of the QMS instead of an on-site audit.

Application for a:

  • Part 1 Full Quality Management System (QMS) certificate for a manufacturer of medical devices
    • Requires a Design and Production QMS assessment
    • The manufacturer has an EU Medical Device Directive (MDD) Full Quality Assurance (FQA) audit report
    • The FQA audit report is a recertification audit report (re-audit) that covers the same manufacturing sites and device categories as your application.
screenshot of table - Part 1 - Full QMS with 'EU MDD/IVDD/AIMDD FQA Audit Report' highlighted under column 'Re-audit (new certification cycle)'

You may provide the FQA audit report (re-audit) to the TGA with the supporting documentation for the application.

If a sufficiently detailed report is provided, then we may be able reduce the assessment by undertaking a desk assessment of the QMS instead of an on-site audit.

You have a current TGA Part 4 Production QMS certificate and:

  • have applied for the assessment of a substantial change
  • the manufacturer has an MDSAP Audit Report for a surveillance audit that includes assessment of the change.
screenshot of table - Part 4 - Production QMS with 'MDSAP Audit Report' highlighted under column 'Surveillance Audit (Annual)'

You may provide the audit report to the TGA with the supporting documentation for the application.

If the report is sufficiently detailed and the change has been assessed as satisfactory by the assessment body, then we may be able to abridge the assessment of the change.

Part B - Applications for ARTG inclusion

Any application for inclusion of a medical device in the ARTG must include certain information as required in the application form. Also, certain information must accompany the application in order to pass a preliminary assessment. If an application does not pass preliminary assessment it will be refused.

The Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Determination 2018 (as amended)sets out what documentation must be provided with an application for inclusion to pass preliminary assessment. This information is summarised in Table 2.

Depending on the category and classification of a medical device, sponsors will have choice of certain documents from overseas regulators and/or assessment bodies which they will be required to provide with their application to meet the requirements as:

  • Manufacturer Evidence (must be submitted, assessed and accepted before submitting an application for your device to be included in ARTG), and
  • Documentation that must be attached to your application for ARTG inclusion.

Please note

Applications for ARTG inclusion of certain medical devices, including IVDs, must be selected for audit (refer regulation 5.3).

TGA may also select any other application for inclusion of a medical device in the ARTG for audit where there are, for example, concerns about the device or information provided in the application.

The Level of audit assessment may depend on the category and/or Class of a medical device, and the overseas evidence provided to the TGA in support of the application.

For an application for inclusion of an IVD medical device, the provision of suitable evidence of product assessment from a comparable overseas regulator may allow for abridgement of an assessment.

Sponsors can submit requests with their applications for a reduction of the audit assessment fees if the audit can be abridged (including for example requests to abridge assessments from Level 2 to Level 1 audit if appropriate). In such cases sponsors are required to provide brief justifications supporting their requests. TGA's delegate will decide whether such request is appropriate.

The guidance on requests for abridged assessment is available on the TGA website.

We have provided some examples on the TGA website on expected level of audit assessment for different devices with different conformity assessment documents.

Requirements when relying on overseas approvals or assessments

Table 2 provides a list of the documents that are required for different Classes of medical devices.

How to use Table 2

Please review the list of conformity assessment documents provided in Table 2 for your Class of medical device.

The categories of documents included as the Manufacturer Evidence and the Evidence of product review attached with your ARTG inclusion application, must appear in the same line in Table 2 to be accepted as the information approved to accompany the application.

If you apply for inclusion in the ARTG of a Class I medical device intended to be supplied sterile (Class Is), and the manufacturer provided you with a copy of their EC Certificate issued by one of the European notified bodies under EU MDD 93/42/EEC, the following documents will be required.

Manufacturer Evidence

The EC Certificate issued under either Annex II.3 or Annex V must be submitted as your Manufacturer Evidence (EC Certificate issued under Annex IV or Annex VI is not appropriate evidence for Class Is medical devices).

screenshot of table - Class Is or Im Export Only with 'Annex II.3, or' and 'Annex V, or' highlighted under column 'Manufacturer Evidence'
Documentation that must be provided with the application for inclusion of your medical device in ARTG

The next part of the table lists the documentation that you must provide with the application for ARTG inclusion of your medical device.

In this case, there is no additional information which needs to be provided.

If you apply for inclusion of a Class IIb medical device in the ARTG, and the manufacturer holds a MDSAP Certificate for their quality management system (QMS) and product approvals from FDA or Health Canada, you will be required to submit these documents as specified below.

Manufacturer Evidence

The MDSAP Certificate issued to the manufacturer of the device must be submitted as Manufacturer Evidence.

Please note

The MDSAP certificate must be issued to the manufacturer stated on the labelling and instructions for use as the manufacturer of the kind of device for which you submitted your application for inclusion in the ARTG.

screenshot of table - Class IIb with 'MDSAP Certificate' highlighted for Health Canada and FDA under column 'Manufacturer Evidence'

Note: ISO 13485 issued by CMDCAS Recognised Registrar is no longer accepted for medical devices.

Documentation that must be provided with the application for inclusion of your medical device in ARTG

In this case, the documentation that you must provide with the application for ARTG inclusion of your medical device must include the following:

  • From
    • Health Canada: Medical device licence Class III,
    or
    • US FDA: De Novo Decision Summary, or 510(k) Summary, or Premarket Approval (PMA).
screenshot - - Class IIb showing Approvals and Documentation examples

*Please note

If you apply for ARTG inclusion of a Class IIb implantable medical device and submitted the manufacturer's MDSAP Certificate, TGA expects PMA from US FDA or Medical device licence Class III issued by Health Canada as the evidence of product review.

The TGA will continue to assess the comparability of US FDA 510k and De Novo approvals when used to support applications for Class IIb implantable medical devices to ensure these approvals are appropriately aligned with Australian regulatory requirements.

As part of this, applications for ARTG inclusion of Class IIb implantable devices are likely to be subjected to an application audit. As a result, the TGA encourages applicants to have and be able to provide the relevant supporting documentation which underpins these types of approvals, and applicants should also expect a request from the TGA for the device's clinical evidence.

If you apply for ARTG inclusion of a Class 3 IVD medical device in the ARTG and the manufacturer provided you with a copy of their EC Certificate issued by one of the European notified bodies under IVDD 98/79/EC, the following documents will be required.

Manufacturer evidence

The EC Certificate issued under either Annex IV.3 or Annex VII must be submitted as your Manufacturer Evidence.

screenshot showing 'Annex IV.3' and 'Annex VII' highlighted under column 'Manufacturer Evidence'
Documentation that must be provided with the application for inclusion of your medical device in ARTG

If you provide an EC Certificate issued under Annex IV.3, there is no additional information which needs to be provided.

If you provide an EC Certificate issued under Annex VII, you will need to provide a Type Examination Certificate (issued under Annex V) with your application.

screenshot showing 'Annex IV.3' and 'N/A' highlighted under columns 'Manufacturer Evidence' and 'Documentation...' and 'Annex VII' and 'Annex V - Type Examination' highlighted under columns 'Manufacturer Evidence' and 'Documentation...'

*Please note

For applications for Class 3 IVDs supported by an ISO 13485:2016 certificate, if no evidence of product assessment by a comparable overseas regulator is provided with the application (e.g., Health Canada Medical device licence Class 3 or Class 4, FDA PMA approval) the application will be subject to a mandatory audit, refer Regulation 5.3(1)(j)(viii).

Note: To improve accessibility, Table 1 has been split into smaller tables on this page, however all tables in this section should be considered part of Table 1.

For TGA-Issued Conformity Assessment Certificates[2]

Part 1 - Full QMS
TGA Conformity Assessment Procedure Comparable Overseas Regulator / Assessment Body evidence which can be provided for abridgement
Product Assessment Initial Audit Surveillance Audit (Annual) Re-audit (new certification cycle)
1.3 Design and Production QMS Assessment (Initial, and Recertification) N/A
  • EU MDD / IVDD / AIMDD Full Quality Assurance (FQA) Audit Report
  • EU MDR / IVDR Quality Management System Audit Report
  • MDSAP[3] Audit Report
  • MDSAP2 Audit Report or
  • EU MDD / IVDD / AIMDD FQA Audit Report or
  • EU MDR / IVDR Audit Report

Accepted in place of a TGA surveillance assessment (with a satisfactory audit scope and in the absence of safety signals)

Considered along with a Re-audit for the purposes of TGA recertification (5 year cycle)

  • MDSAP[2] Audit Report or
  • EU MDD / IVDD / AIMDD FQA Audit Report or
  • EU MDR / IVDR Audit Report

Accepted in place of a TGA surveillance assessment (with a satisfactory audit scope and in the absence of safety signals)

1.5 Assessment of changes to the Design and Production QMS N/A N/A
  • MDSAP[2] Audit Report or
  • EU MDD / IVDD / AIMDD FQA Audit Report or
  • EU MDR / IVDR Audit Report

Considered for the purposes of abridging TGA's assessment of the change.

  • MDSAP[2] Audit Report or
  • EU MDD / IVDD / AIMDD FQA Audit Report or
  • EU MDR / IVDR Audit Report

Considered for the purposes of abridging TGA's assessment of the change.

1.6 Examination of the design
  • PMA (US FDA)
  • MDL (Health Canada)
  • Product Certification (PMDA)
  • EU MDD / AIMDD Annex II.4 Report
  • EU MDR / IVDR Annex IX - EU technical documentation report
  • EU IVDD Annex IV.4 Report
N/A N/A N/A
Part 2 - Type Examination
TGA Conformity Assessment Procedure Comparable Overseas Regulator / Assessment Body evidence which can be provided for abridgement
Product Assessment Initial Audit Surveillance Audit (Annual) Re-audit (new certification cycle)
2.3 Examination of the Type
  • EU MDD Annex III Report
  • EU MDR / IVDR Annex X - EU type-examination report
  • EU IVDD Annex V Report
  • EU AIMDD Annex 3 Report
N/A N/A N/A
2.4 Examination of changes to the Type N/A N/A N/A
Part 3 - Verification
TGA Conformity Assessment Procedure Comparable Overseas Regulator / Assessment Body evidence which can be provided for abridgement
Product Assessment Initial Audit Surveillance Audit (Annual) Re-audit (new certification cycle)
3.3 100% or Batch Verification N/A N/A N/A N/A
Part 4 - Production QMS
TGA Conformity Assessment Procedure Comparable Overseas Regulator / Assessment Body evidence which can be provided for abridgement
Product Assessment Initial Audit Surveillance Audit (Annual) Re-audit (new certification cycle)
4.3 Production QMS Assessment N/A
  • EU MDD / IVDD / AIMDD Full Quality Assurance or Production Quality Assurance (PQA) Audit Report
  • EU MDR / IVDR Quality Management System Audit Report
  • MDSAP Audit Report
  • EU MDD / IVDD / AIMDD FQA Audit Report or
  • EU MDD PQA Audit Report or
  • EU MDR / IVDR Audit Report or
  • MDSAP Audit Report

Accepted in place of a TGA surveillance assessment (with a satisfactory audit scope and in the absence of safety signals)

Considered along with a Re-audit for the purposes of TGA recertification (5 year cycle)

  • EU MDD / IVDD / AIMDD FQA Audit Report or
  • EU MDD PQA Audit Report or
  • EU MDR / IVDR Audit Report
  • MDSAP Audit Report

Accepted in place of a TGA surveillance assessment (with a satisfactory audit scope and in the absence of safety signals)

4.5 Assessment of changes to Production QMS N/A N/A
  • EU MDD FQA Audit Report or
  • EU MDR / IVDR Audit Report or
  • MDSAP Audit Report

Considered for the purposes of abridging TGA's assessment of the change.

  • EU MDD FQA Audit Report or
  • EU MDR / IVDR Audit Report or
  • MDSAP Audit Report

Considered for the purposes of abridging TGA's assessment of the change.

Part 5 - Product QMS
TGA Conformity Assessment Procedure Comparable Overseas Regulator / Assessment Body evidence which can be provided for abridgement
Product Assessment Initial Audit Surveillance Audit (Annual) Re-audit (new certification cycle)
5.3 Product QMS Assessment N/A N/A N/A N/A
5.5 Assessment of changes to Product QMS N/A N/A N/A N/A
Notes on use of MDSAP evidence:
  1. MDSAP Certificates are issued to Manufacturers as defined by GHTF. Those legal entities that take responsibility for design, production, packaging and labelling etc. before placing on the market under their own name. Proposed that MDSAP certificates will only be used by Canada and Australia.
  2. MDSAP Reports are prepared for medical device organisations (Sites), including the site(s) of the manufacturer, that are audited. A site is variously defined in Brazilian, Japanese and US regulations as a location that undertakes specific types of activities related to the manufacture of a medical device. (i.e., a step in manufacture of a MD).
  3. An MDSAP report may relate to a Site that is within the scope of a Manufacturer's QMS, or may relate to a Supplier to a Manufacturer. The TGA's expectation is that a Manufacturer is responsible for all aspects of a QMS related to their device. An MDSAP AO's report shall similarly account for all aspects of the Manufacturer's QMS.
  4. The TGA can only use certificates and reports that relate to Manufacturers.
  5. If a manufacturer chooses to apply a CA procedure for a higher class of medical device, the criteria for accepting MDSAP reports or certification applies as if the device was classified at that higher class.

Note: To improve accessibility, Table 2 has been split into smaller tables on this page, however all tables in this section should be considered part of Table 2.

Medical Devices (not including IVDs)

Class I and Class I Export only (Regulation 3.9(1))
Regulators / Approvals Manufacturer Evidence
(QMS Certificate)
Documentation to be provided with the application
(Evidence of product assessment)
TGA N/A N/A
Class Is or Im (supplied in a sterile state or with measuring function) (Regulation 3.9(2) and 3.9(3))
Regulators / Approvals Manufacturer Evidence
(QMS Certificate)
Documentation that must be provided with the application
(Evidence of product assessment)

TGA

CAC - MD Regulations Schedule 3 [4]

  • Part 1 - Full Quality Assurance (excluding clause 1.6 Design Examination), or
  • Part 3 - Verification (not applicable for Class Is), or
  • Part 4 - Production Quality Assurance, or
  • Part 5 - Product Quality Assurance (not applicable for Class Is)
N/A

EU

EU MDD 93/42/EEC[5]

  • Annex II.3, or
  • Annex IV (specific batches are included on the certificate) (not applicable for Class Is), or
  • Annex V, or
  • Annex VI ('metrology aspects' or equivalent wording) (not applicable for Class Is)

EU

EU 90/385/EEC (AIMDD) for AIMD[6]

  • Annex 2.3, or
  • Annex 4 (for non-sterile devices where specific batches are included on the certificate), or
  • Annex 5

EU

EU MDR[7]

Limited to establishing and maintaining sterility; or conformity with metrological requirements; or aspects related to reuse of the device:

  • Annex IX, Chapter I (QMS) and III
  • Annex XI (Product Conformity Verification), Part A
MDSAP MDSAP Certificate
Class IIa (Regulation 3.8)
Regulators / Approvals Manufacturer Evidence
(QMS Certificate)
Documentation that must be provided with the application
(Evidence of product assessment)

TGA

CAC - MD Regulations Schedule 3

  • Part 1 - Full Quality Assurance (excluding clause 1.6 Design Examination), or
  • Part 3 - Verification (for non-sterile devices), or
  • Part 4 - Production Quality Assurance, or
  • Part 5 - Product Quality Assurance (for non-sterile devices)
N/A

EU

EU MDD 93/42/EEC[4]

  • Annex II.3, or
  • Annex IV (for non-sterile devices where specific batches are included on the certificate), or
  • Annex V, or
  • Annex VI (for non-sterile devices)
N/A

EU

EU 90/385/EEC (AIMDD) for AIMD[8]

  • Annex 2.3, or
  • Annex 4 (for non-sterile devices where specific batches are included on the certificate), or
  • Annex 5
N/A

EU

EU MDR[9]

Annex IX, Chapter I (QMS) and III Section 4, Annex IX (technical documentation)
Annexes II and III Section 10 or Section 18 of Annex XI (one representative device per category)

Japan

Ministry of Health, Labour and Welfare (MHLW)/PMDA

  • QMS certificate, or
  • MDSAP Certificate
Pre-market certificate

Health Canada

MDR SOR/98-282[10]

  • MDSAP Certificate
Medical device licence Class II

FDA

DeNovo

MDSAP Certificate De Novo Decision Summary

FDA

Premarket Notification - 510(k)

MDSAP Certificate 510(k) - Summary
Class IIb (Regulation 3.7)
Regulators / Approvals Manufacturer Evidence
(QMS Certificate)
Documentation that must be provided with the application
(Evidence of product assessment)

TGA

CAC - MD Regulations Schedule 3[11]

Part 1 - Full Quality Assurance (excluding clause 1.6 Design Examination) N/A
  • Part 3 - Verification (for non-sterile devices), or
  • Part 4 - Production Quality Assurance, or
  • Part 5 - Product Quality Assurance (for non-sterile devices)
Part 2 - Type Examination

EU

EU MDD 93/42/EEC[12]

Annex II.3 N/A
  • Annex IV (for non-sterile devices where specific batches are included on the certificate), or
  • Annex V, or
  • Annex VI (for non-sterile devices)
Annex III

EU

EU 90/385/EEC (AIMDD) for AIMD[7]

Annex 2.3 N/A

EU

EU MDR[13]

Annex IX, Chapter I (QMS) and III Annex IX, Section 4 (TDA) (based on a representative sample, BUT Class IIb implantable, for each device, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.
Annexes XI (Product Conformity Verification) Annex X - Type Examination

Japan

Ministry of Health, Labour and Welfare (MHLW)/PMDA

  • QMS certificate, or
  • MDSAP Certificate
Pre-market certificate

Health Canada

MDR SOR/98-282[14]

  • MDSAP Certificate
Medical device licence Class III

FDA

DeNovo[15]

MDSAP Certificate De Novo Decision Summary

FDA

Premarket Notification - 510(k)

MDSAP Certificate 510(k) - Summary

FDA

Premarket Approval (PMA)

MDSAP Certificate (or PMA) PMA
Class III and AIMD[16] (Regulation 3.6)
Regulators / Approvals Manufacturer Evidence
(QMS Certificate)
Documentation that must be provided with the application
(Evidence of product assessment)

TGA

CAC - MD Regulations Schedule 3[17]

Part 1 - Full Quality Assurance (excluding clause 1.6 Design Examination) Part 1 - clause 1.6 Design Examination
  • Part 3 - Verification (for non-sterile devices), or
  • Part 4 - Production Quality Assurance
Part 2 - Type Examination

EU

EU MDD 93/42/EEC[18] for Class III

Annex II.3 Annex II.4 - Design Examination
  • Annex IV (for non-sterile devices where specific batches are included on the certificate), or
  • Annex V
Annex III - Type Examination

EU

EU 90/385/EEC[19] (AIMDD) for AIMD

Annex 2.3 Annex 2.4 - Design Examination
  • Annex 4 (for non-sterile devices where specific batches are included on the certificate), or
  • Annex 5
Annex 3

EU

EU MDR[20]

Annex IX (QMS) Annex IX (TDA)
Annexes XI (Product Conformity Verification) Annex X - Type Examination

Japan

Ministry of Health, Labour and Welfare (MHLW)/PMDA

  • QMS certificate, or
  • MDSAP Certificate
Pre-market approval certificate

Health Canada

MDR SOR/98-282M[21]

  • MDSAP Certificate
Medical device licence Class IV

FDA

Premarket Approval (PMA)

MDSAP Certificate (or PMA) PMA
Procedure Pack or System (Regulation 3.10(1)(d) or (e) whatever is relevant)
Regulators / Approvals Manufacturer Evidence
(QMS Certificate)
Documentation that must be provided with the application
(Evidence of product assessment)

TGA[22]

DOC

Declaration of conformity made under Clause 7.5 of Schedule 3 of MD Regulations Evidence of the appropriate conformity assessment procedures applied to each medical device in the system/pack

IVDs

Class 1 IVD and Class 1 IVD Export only (Regulation 3.9A)
Regulators / Approvals Manufacturer Evidence
(QMS Certificate)
Documentation that must be provided with the application
(Evidence of product assessment)
TGA N/A N/A
Class 2 IVD (Regulation 3.8A)
Regulators / Approvals Manufacturer Evidence
(QMS Certificate)
Documentation that must be provided with the application
(Evidence of product assessment)

TGA

CAC - MD Regulations Schedule 3[23]

  • Part 1 - Full Quality Assurance (excluding clause 1.6 Design Examination), or
  • Part 4 - Production Quality Assurance
N/A

EU

IVDD 98/79/EC[24] in vitro diagnostic medical devices

  • Annex IV.3, or
  • Annex VII
N/A

EU

EU IVD regulations[25]

Annex IX, Chapter I

Annex IX, Sections 4.4 to 4.8 (based on representative sample)

For self-testing and near-patient testing: TDA set out in Section 5.1 of Annex IX

FDA

Premarket Notification - 510(k)

MDSAP Certificate 510(k) Summary
Health Canada
  • ISO 13485:2016 issued by CMDCAS Recognised Registrar, or
  • MDSAP Certificate
Medical device licence Class II
MDSAP MDSAP Certificate N/A
ISO 13485 ISO 13485:2016 issued by a certification body that is also a Notified Body designated under the IVDD 98/79/EC (only accepted for applications submitted before 26 May 2022) N/A
ISO 13485 ISO 13485:2016 issued by an accredited body that is a signatory to the Multilateral Recognition Arrangement of the International Accreditation Forum (IAF MLA) (only accepted for applications submitted before 26 May 2022) N/A
Class 3 IVD (Regulation 3.7A)
Regulators / Approvals Manufacturer Evidence
(QMS Certificate)
Documentation that must be provided with the application
(Evidence of product assessment)

TGA

CAC - MD Regulations Schedule 3

Part 1 - Full Quality Assurance (excluding clause 1.6 Design Examination) N/A
Part 4 - Production Quality Assurance Part 2 - Type Examination

EU

IVDD 98/79/EC in vitro diagnostic medical devices

Annex IV.3 N/A
Annex VII Annex V - Type Examination

EU

EU IVD regulations[26]

Annex IX (QMS) Chapter I Annex IX, Sections 4.4 to 4.8 (at least one representative device per group) (for self-testing and near-patient testing: TDA set out in Section 5.1)
Annex XI (Production Quality Assurance) except Section 5 Annex X - Type Examination[7]

FDA

Premarket Notification - 510(k)

MDSAP Certificate 510(k) - Summary

FDA

Premarket Approval (PMA)

MDSAP Certificate (or PMA) PMA
Health Canada
  • ISO 13485:2016 issued by CMDCAS Recognised Registrar[27]
  • MDSAP Certificate
Medical device licence Class III
MDSAP MDSAP Certificate N/A
ISO 13485 ISO 13485:2016 issued by a certification body that is also a Notified Body designated under the IVDD 98/79/EC (only accepted for applications submitted before 26 May 2022) N/A
ISO 13485 ISO 13485:2016 issued by an accredited body that is a signatory to the Multilateral Recognition Arrangement of the International Accreditation Forum (IAF MLA) (only accepted for applications submitted before 26 May 2022) N/A
Class 4 IVD (Regulation 3.6A)
Regulators / Approvals Manufacturer Evidence
(QMS Certificate)
Documentation that must be provided with the application
(Evidence of product assessment)

TGA

CAC - MD Regulations Schedule 3[28]

Part 1 - Full Quality Assurance (excluding clause 1.6 Design Examination) Part 1 - clause 1.6 Design Examination
Part 4 - Production Quality Assurance Part 2 - Type Examination
Class 4 In-House IVD (Regulation 3.6B)
Regulators / Approvals Manufacturer Evidence
(QMS Certificate)
Documentation that must be provided with the application
(Evidence of product assessment)

TGA

CAC - MD Regulations Schedule 3

Part 1 - Full Quality Assurance (excluding clause 1.6 Design Examination) Part 1 - clause 1.6 Design Examination
Part 6B - GMP licence
Part 6B - NATA accreditation

Footnotes


Version history
Version Description of change Author Effective date
V1.0 Original publication Medical Devices Branch, Therapeutic Goods Administration 20/08/2018
V1.1 Clarification of acceptable ISO 13485 certificates for IVD medical devices Medical Devices Branch, Therapeutic Goods Administration 26/11/2018
V1.2 Further clarification on acceptable ISO 13485:2016 certificates for IVD medical devices. Removal of requirement for attachment of Health Canada Medical licence listing for applications for Class 2 and Class 3 IVD medical devices (to pass preliminary assessment). Removal of CMDCAS reference for medical devices (i.e., non IVD medical devices) Medical Devices Branch, Therapeutic Goods Administration May 2019
V1.3 Insertion of links to legislative instruments and related notations Medical Devices Branch, Therapeutic Goods Administration July 2019