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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
Published
Last updated

On 23 July 2021, the Australian Government made a decision to repeal Regulation 4.1 and amend Regulation 5.3 of the Therapeutic Goods (Medical Devices) Regulations 2002.

This means that from 28 July 2021, the range of applications for inclusion in the Australian Register of Therapeutic Goods (ARTG) that can rely on conformity assessment documents issued by European notified bodies was expanded. These amendments have changed the conformity assessment certification and audit requirements for medical devices that contain medicines or materials of animal, microbial, recombinant or human origin; and Class 4 in vitro diagnostic (IVD) medical devices.

Before the change, under regulation 4.1, sponsors of such devices could only rely on conformity assessment certification by the Therapeutic Goods Administration (TGA) for inclusion in the Australian Register of Therapeutic Goods (ARTG) for these types of devices.

Now sponsors can provide conformity assessment documents issued by notified bodies designated by a member state of the European Union to support an application for inclusion in the ARTG. These changes recognise the significantly enhanced standards, processes and clinical evaluation requirements contained in the European Union's (EU) Regulations for Medical Devices and In Vitro Diagnostics. It is important to note that Australia has some different regulatory requirements to Europe (e.g.: biologicals) and therefore, the amendment to Regulation 5.3 provides for the TGA to audit applications to ensure the information provided meets the Australian regulatory requirements (see below for further information) prior to approval for supply in Australia.

The TGA remains responsible for including all medical devices in the ARTG. The TGA will continue to provide product assessments and quality management assessment when required by legislation or at the request of a manufacturer.

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 union member states, under the medical device regulatory frameworks of the European Union (Medical devices directives[1], IVD Directive, 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), which is applicable)
  • Registrations of the Singapore Health Sciences Authority (HSA)
  • 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 until 26 May 2023)
  • 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 until 26 May 2023).

* 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 you are applying to have included in the ARTG. The device must:

  • have the same design and intended purpose
  • be intended for the same indications.

Table 1 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 the safety, quality, and performance of medical devices authorised for supply in Australia, and no change to the TGA's existing regulatory requirements and processes.

In this section: Reduction of assessment fees for medical devices | How to use this section | Part A - Abridgement of TGA conformity assessment | Part B - Applications for ARTG inclusion | Table 1: Evidence that may be used for abridgement of TGA conformity assessment | Table 2: Information that must accompany ARTG inclusion applications

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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An application for a:

  • Part 1 Full Quality Management System (QMS) certificate for a manufacturer of medical devices requires:
    • a Design and Production QMS assessment
    • that the manufacturer has an EU Medical Device Directive (MDD) Full Quality Assurance (FQA) audit report
    • that the FQA audit report is an initial audit report that covers the same manufacturing sites and device categories as your application.
Example A - Initial application for TGA conformity assessment certificate using overseas initial audit evidence

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.

An application for a:

  • Part 1 Full Quality Management System (QMS) certificate for a manufacturer of medical devices requires:
    • a Design and Production QMS assessment
    • that the manufacturer has an EU Medical Device Directive (MDD) Full Quality Assurance (FQA) audit report
    • that the FQA audit report is a recertification audit report (re-audit) that covers the same manufacturing sites and device categories as your application.
Example B - Initial application for TGA conformity assessment certificate using overseas re-audit evidence

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.
Example C - Assessing substantial change to a TGA Production QMS Certificate

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 can choose certain documents from overseas regulators and/or assessment bodies which they will be required to provide with their applications to meet the requirements for:

  • Manufacturer Evidence (must be submitted, assessed and accepted before you submit an application for your device to be included in ARTG), and
  • evidence of product assessment (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 to regulation 5.3).

The TGA may also select any other application for inclusion of a medical device in the ARTG for audit, for example, where there are 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 assessment 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).

Example A - Class Is medical device
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.

Example B - Class IIb medical device - Manufacturer Evidence

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

Evidence of product assessment 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 or
    • Health Canada: Medical device licence Class III,
    • US FDA: De Novo Decision Summary, or 510(k) Summary, or Premarket Approval (PMA).
Example B - Class IIb medical device - Evidence of product assessment that must be provided with the application for inclusion of your medical device in ARTG
 

*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 assessment.

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 may 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.

Example C - Class 3 IVD medical device - Manufacturer Evidence
Evidence of product assessment 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.

Example C - Class 3 IVD medical device - Evidence of product assessment that must be provided with the application for inclusion of your medical device in ARTG

*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 (such as Health Canada Medical Device Licence Class 3 or Class 4; or FDA PMA approval) the application will be subject to a mandatory audit, refer Regulation 5.3(1)(j)(viii).

Document requirement tables

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

In this section: Part 1 - Full QMS | Part 2 - Type Examination | Part 3 - Verification | Part 4 - Production QMS | Part 5 - Product QMS | Notes on use of MDSAP evidence

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 Audit Report
  • MDSAP 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 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 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 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. (that is, 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.

In this section: Medical Devices (not including IVDs) | IVDs

Medical Devices (not including IVDs)

In this section: Class I and Class I Export only | Class Is or Im (supplied in a sterile state or with measuring function) | Class IIa | Class IIb | Class III and AIMD | Class III and AIMD | Procedure Pack or System

Class I non-sterile, non-measuring (Regulation 3.9(1))
Regulators / Approvals Manufacturer Evidence
(QMS Certificate)		 Documentation to be provided with the application
(Evidence of product assessment)
TGA Declaration of conformity made under clause 6.6 of Schedule 3 of MD Regulations N/A
Class I Procedure Pack or System Regulation 3.10(1)9d) or (e) whatever is relevant
Regulators / Approvals Manufacturer Evidence
(QMS Certificate)		 Documentation to be provided with the application
(Evidence of product assessment)
TGA Declaration of conformity made under clause 7.5 of Schedule 3 of MD Regulations N/A
Class I Export only
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
  • 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
  • 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
  • Annex 2.3, or
  • Annex 4 (for non-sterile devices where specific batches are included on the certificate), or
  • Annex 5

EU

EU MDR

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

  • Annex IX, Chapter I (QMS)
  • 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
  • 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
  • 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

 Annex IX, Chapter I (QMS) Section 4, Annex IX (Assessment of 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
  • 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
Singapore HSA Current registration as a Class B medical device N/A
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

 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

 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

 Annex 2.3 N/A

EU

EU MDR

 Annex IX, Chapter I (QMS) Annex IX, Chapter II (Assessment of Technical Documentation) (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
  • MDSAP Certificate
 Medical device licence Class III

FDA

DeNovo

 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
Singapore HSA Current registration as a Class C medical device N/A
Class III and AIMD (Regulation 3.6 (except specified medical devices). These are medical devices that do not contain medicines or materials of animal, microbial, recombinant or human origin. Class III and AIMD (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

 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 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 (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

 Annex IX (QMS) Annex IX (Assessment of Technical Documentation)
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
  • MDSAP Certificate
 Medical device licence Class IV

FDA

Premarket Approval (PMA)

 MDSAP Certificate (or PMA) PMA
Singapore HSA Current registration as a Class D medical device N/A
Class III and AIMD (Regulation 3.6) (specified medical devices) These are medical devices contain medicines or materials of animal, microbial, recombinant or human origin.
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 3 - Verification (for non-sterile devices), or
  • Part 4 - Production Quality Assurance

Part 1 - clause 1.6 Design Examination

Part 2 - Type Examination

EU

EU MDD 93/42/EEC 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 (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

 Annex IX (QMS) Annex IX (Assessment of Technical Documentation)
Annex XI (Product Conformity Verification) Annex X - Type Examination
Procedure Pack or System (other than Class I) (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

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

In this section: Class 1 IVD and Class 1 IVD Export only | Class 2 IVD | Class 3 IVD | Class 4 IVD | Class 4 In-House IVD

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

EU

IVDD 98/79/EC in vitro diagnostic medical devices
  • Annex IV.3, or
  • Annex VII
 N/A

EU

EU IVD regulations

 Annex IX, Chapter I

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

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

FDA

Premarket Notification - 510(k)

 MDSAP Certificate 510(k) Summary
Health Canada
  • MDSAP Certificate
  • A quality management system certificate for the purposes of the Canadian medical devices regulations
 Medical device licence Class II
Singapore HSA Evidence of a current registration as a Class B IVD N/A
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 accepted for Class 2 IVD applications submitted before 26 May 2023
  • ISO 13485:2016 issued by a certification body that is also a Notified Body designated under the IVDD 98/79/EC accepted for Class 2 IVD applications submitted before 26 May 2027 if the manufacturer also has a signed EU declaration of conformity issued under Annex III of the IVD Directive (IVDD) 98/79/EC 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)  accepted for Class 2 IVD applications submitted before 26 May 2023
  • ISO 13485:2016 issued by an accredited body that is a signatory to the Multilateral Recognition Arrangement of the International Accreditation Forum (IAF MLA) accepted for Class 2 IVD applications submitted before 26 May 2027 if the manufacturer also has a signed EU declaration of conformity issued under Annex III of the IVD Directive (IVDD) 98/79/EC 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

 Annex IX (QMS) Chapter I

Annex IX, Chapter II (at least one representative device per group).

For self-testing and near-patient testing: Assessment of Technical documentation set out in Section 5.1;

For companion diagnostics: Assessment of Technical Documentation set out in Reg 5.2
Annex XI (Production Quality Assurance) except Section 5 Annex X - Type Examination

FDA

Premarket Notification - 510(k)

 MDSAP Certificate 510(k) - Summary

FDA

Premarket Approval (PMA)

 MDSAP Certificate (or PMA) PMA
Health Canada
  • MDSAP Certificate
  • A quality management system certificate for the purposes of the Canadian medical devices regulations
 Medical device licence Class III
Singapore HSA Evidence of a current registration as a Class C IVD N/A
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 accepted for Class 3 IVD applications submitted before 26 May 2023
  • ISO 13485:2016 issued by a certification body that is also a Notified Body designated under the IVDD 98/79/EC accepted for Class 3 IVD applications submitted before 26 May 2026 if the manufacturer also has a signed EU declaration of conformity issued under Annex III of the IVD Directive (IVDD) 98/79/EC before 26 May 2022

N/A

EU declaration of conformity issued under Annex III of the IVD Directive (IVDD) 98/79/EC before 26 May 2022
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) accepted for Class 3 IVD applications submitted before 26 May 2023
  • ISO 13485:2016 issued by an accredited body that is a signatory to the Multilateral Recognition Arrangement of the International Accreditation Forum (IAF MLA) accepted for Class 3 IVD applications submitted before 26 May 2026 if the manufacturer also has a signed EU declaration of conformity issued under Annex III of the IVD Directive (IVDD) 98/79/EC before 26 May 2022

N/A

EU declaration of conformity issued under Annex III of the IVD Directive (IVDD) 98/79/EC before 26 May 2022
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

 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

EU

IVDD 98/79/EC in vitro diagnostic medical devices

 Annex IV.3 Annex IV - Design examination
Annex VII Annex V - Type Examination

EU

EU IVD regulations

 Annex IX (QMS) Chapter I Annex IX (QMS) Chapter II - Design examination
Annex XI (Production Quality Assurance) except Section 5 Annex X - 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
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 (that is, 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
V1.4 Amendments to reflect changes to application process and requirements for inclusion of Class I non-sterile, non-measuring devices Medical Devices Authorisation and Surveillance Branches, Therapeutic Goods Administration October 2020
V1.5 Amendments to reflect the repeal of Therapeutic Goods (Medical Devices) Regulations 2002, Regulation 4.1 (requirement for TGA conformity assessment for medical devices containing medicines or materials of animal, microbial, recombinant or human origin, or Class 4 IVDs Medical Devices Authorisation and Surveillance Branches, Therapeutic Goods Administration September 2021
V1.6 Amendments to reflect the extended acceptance of  ISO13485 certificates as manufacturer evidence for IVD applications in line with EU IVDR (2017/746). Medical Devices Authorisation and Surveillance Branches, Therapeutic Goods Administration May 2022
V1.7 Amendments to include Singapore's HSA as a comparable overseas regulator Medical Devices Authorisation and Surveillance Branches, Therapeutic Goods Administration September 2022
V1.8 Amendments to clarify the requirements for EUMDR Medical Devices Authorisation Branch and Medical Devices Surveillance Branch May 2023

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