Frequently asked questions for the Medical Device Single Audit Program (MDSAP)

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Facility registration

The Auditing Organisation has asked for a facility registration or facility identification number during an MDSAP audit. What evidence should I provide?

Auditing Organisations must include all applicable facility identification numbers in their audit reports. We do not publish facility identification numbers.

If you have an entry in the Australian Register of Therapeutic goods (ARTG) or have applied for one, and do not have your facility identification number, you can email MDSAP@health.gov.au with the name and address of the facility.

If you have no ARTG entries or applications, then you can respond to the Auditing Organisation with ‘Not Applicable’. An ID number for the site will not be created until an Australian sponsor applies to the TGA to include a device from that manufacturer in the ARTG.

Global Medical Device Nomenclature (GMDN)

The GMDN Agency lists the GMDN term that is on my ARTG entry and manufacturer’s Declaration of Conformity as obsolete. Is the term still valid?

Yes, the GMDN term that we have published on the ARTG entry remains valid.

Should the GMDN term on the manufacturer’s Declaration of Conformity always match the information on the ARTG entry?

The GMDN term that we have published on the ARTG entry is valid. It may not always match the term on the manufacturer’s Declaration of Conformity.

Declaration of Conformity

Is the MDD information on my Declaration of Conformity still valid post MDR certification of this device?

No. The manufacturer must keep their Declaration of Conformity up to date and provide it to us upon request. Once the manufacturer is certified under the EU Medical Device Regulation (MDR), the Medical Device Directive (MDD) reference is out of date, and they should update the Declaration of Conformity. Refer to the Guidance for Declaration of Conformity Procedures.

What is an appropriate timeframe to update a Declaration of Conformity?

The manufacturer must keep their Declaration of Conformity up to date and provide it to us upon request. There is no specific timeframe for updating the Declaration of Conformity.

ARTG registration and comparable overseas evidence

If the ARTG inclusion is supported by the appropriate EU Certification and this is maintained, is it still necessary for the manufacturer to also include the product in the scope of the MDSAP audit?

Yes, although we accept EU certification, MDSAP rules require Australian requirements to be included in the MDSAP audit if the product is (or intended to be) supplied to Australia. You can refer to the MDSAP Frequently Asked Questions (question 95) and the Audit Approach (page 6), on the US Food and Drug Administration website.

If the ARTG inclusion is for class III device containing medicines or materials of animal, microbial, recombinant, or human origin, and is supported by appropriate EU Certification, does the manufacturer need to include product in scope of MDSAP audit?

Yes, the MDSAP rules (see the explanation in the question above) apply to all classes of devices other than Class I devices and Class 1 IVD’s.

Why is an MDSAP certificate required as Manufacturer’s Evidence when from the US FDA or Health Canada, but no similar or equivalent QMS document is required to be used as Manufacturer’s Evidence when using a comparable overseas approval from Singapore?

The Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Determination 2018 sets out the evidence you need to submit with an application for ARTG inclusion.

Product approvals from the US FDA or Health Canada do not cover the quality management system, and hence the applicant must provide the MDSAP certificate.

Singapore’s HSA approvals cover both the quality management system and product assessment and so an additional document is not needed.

Does using an MDSAP certificate as Manufacturer’s Evidence (instead of the US FDA PMA) have any benefit when using US FDA PMA as the comparable overseas evidence?

The kind of quality management system evidence used (e.g. MDSAP vs FDA PMA) does not influence whether an application is selected for audit and does not influence the level of the application audit.

Further guidance is provided at Auditing of Medical Device Applications.

If you are unsure, you can contact devices@tga.gov.au.

The information about comparable overseas regulator evidence indicates that MDSAP certification alone can be used as evidence of QMS and product assessment for Class 2 and Class 3 IVDs, but also says that a 510K is needed. Can you please clarify?

We accept applications for Class 2 or 3 IVDs with MDSAP certification either with or without US FDA 510(k) approval. See the Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Determination 2018.

Both options are acceptable for applying to us, but we are unlikely to select applications with US FDA 510(k) approval for application audit, while we are likely to select those without comparable overseas regulator product approval for application audit. This is because the US FDA 510(k) approval provides evidence that a comparable overseas regulator has approved the device, while the MDSAP certificate does not, since it only covers the manufacturer’s quality management system.

Further guidance is provided at Auditing of Medical Device Applications.

Other Regulatory Requirements

What evidence do I need to demonstrate that my device complies with patient implant card & patient information leaflet requirements during a MDSAP audit?

Essential principles 13A.2 and 13A.3 require the manufacturer to provide a patient implant card and patient information leaflet for most implantable devices.

An MDSAP auditor will need to see that:

a patient implant card is available for patients, it includes the information in essential principle 13A.2(2), and it is provided in a way to meet essential principle 13A.4
a patient implant leaflet is available for patients, it includes the information in essential principles 13A.3(2) & (3), and it is provided either as a leaflet or in a readily accessible electronic form in a way to meet essential principle 13A.4.

Refer to Patient implant cards and information leaflets for additional information. This link also contains information for sponsors on how to apply for consent to import, supply, or export a medical device that does not comply with the essential principles.

What is the expected timeline for adverse event reporting to the TGA?

The manufacturer must report adverse events to us, or sponsor, as soon as practicable after becoming aware of the event (Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 3 P1 1.4 (3) (c)(ii)).

The adverse event reporting timelines are a condition of the device inclusion in the ARTG, and apply to the sponsor, but often cannot be achieved without the help of the manufacturer.

You can refer to Regulation 5.7 - Therapeutic Goods (Medical Devices) Regulations 2002, which outlines the reporting timeline requirements of sponsors.

As a sponsor, I have a direct relationship with the legal manufacturer via a quality agreement. The parent company directly liaises between us and the third-party manufacturer. Do I need a quality agreement separately with the third-party manufacturer?

No, the written agreement is only required between the sponsor and the manufacturer who is represented on the device label. However, some sponsors may choose to have an agreement with the third-party manufacturer.

Sponsor information is missing on the device label. How can I demonstrate compliance with Regulation 10.2?

Regulation 10.2 requires sponsors to provide their name and address with all devices they supply in Australia. This information should be located:

to allow the user of the device to readily identify the sponsor
appropriately for the device according to Essential Principle 13.2:
- sponsors should ensure that their name and address is provided on the device itself
- if it is not practicable to provide this on the device, this information should be included on the packaging used for the device
- further, if it is not practicable for these details to be provided on the device itself or the packaging used for the device, the sponsor's name and address must be included in a leaflet supplied with the device.

If the sponsor applies a separate label, then this is not an auditable requirement for the manufacturer and outside the scope of a MDSAP audit. If the manufacturer includes the sponsor information in their label, then it is an auditable requirement, and the Auditing Organisation can verify the label during the MDSAP audit and confirm the requirements and responsibilities are defined in a written agreement.

The MDSAP audit approach mentions the Essential Principles Checklist. Is this a mandatory document?

Maintaining an Essential Principles Checklist is not mandatory. You can refer to the checklist example in the MDSAP Audit Approach, on the US Food and Drug Administration website. This shows how a manufacturer could demonstrate, through an index of objective evidence, that evidence of compliance to the Essential Principles is available.

MDSAP documentation

Is there a consolidated list of IMDRF requirements and guidance used for the assessment by authorities for MDSAP?

Yes, applicable MDSAP requirements and guidance are available on the US Food and Drug Administration website at:

How often is the Audit Approach document (MDSAP-AU-P0002) reviewed and updated?

Reviews occur as needed to address applicable regulatory changes or stakeholder feedback. In October 2023, the Audit Approach document was at revision 8 (MDSAP-AU-P0002.008).

How do I know when a new version of the MDSAP Audit Approach has been published?

You can subscribe to email updates on the MDSAP documents page of the US Food and Drug Administration website.

The publication of a new or updated MDSAP document will generate a notification email.

TGA and the MDSAP

How does the TGA ensure participating Auditing Organisations (AOs) are adequately trained and knowledgeable in the relevant Australian legislative requirements? How often does re-training occur?

The MDSAP Auditing Organisations are responsible for training their auditors, including re-training. The TGA and other Regulatory Authority members assess the Auditing Organisation auditor training programs during head office assessments and when witnessing MDSAP audits. We are not involved in every assessment of every Auditing Organisation and the MDSAP Regulatory Authorities do not directly assess the competency of each auditor.

Our regulatory requirements are described in training material sent to MDSAP Auditing Organisations to train their auditors. Auditing Organisations must only qualify auditors who have demonstrated an understanding of the regulatory requirements of all the participating Regulatory Authorities including the TGA.

We update the training material sent to the Auditing Organisations as needed and provide at annual regulatory update at MDSAP Forums. We also update the Auditing Organisations through changes to the MDSAP Audit Approach document.

You can email MDSAP@health.gov.au queries about MDSAP audits.

Is there any plan for the TGA to become an MDSAP AO? If not, why not?

No. The TGA is an MDSAP Regulatory Authority that impartially assesses Auditing Organisations. We are not planning to be an MDSAP Auditing Organisation since this would compromise our MDSAP Regulatory Authority role.

When or why does the TGA skip a scheduled audit (in relation to a TGA CA certificate) when relying on MDSAP certificates and audit reports? When or why will the TGA still conduct their own onsite audits?

For manufacturers applying for or holding a TGA conformity assessment certificate that also have MDSAP certification, the TGA performs a desk top review of MDSAP audit reports. The desk top review also reviews other inputs such as any additional supporting information provided by the applicant, and whether we have received any post market signals about devices from this manufacturer. If the MDSAP audit reports provide suitable evidence of compliance to the MDSAP Audit Approach, then the next scheduled TGA audit will generally be skipped.

However, if the desk top review identifies gaps, and subject to the outcome of other TGA technical reviews (for example Microbiology, Engineering, Biomaterials or Clinical assessments), we may decide to perform a targeted (reduced scope) or full onsite audit of the manufacturer.

A standard condition of a TGA Conformity Assessment Certificate is that we may perform an audit at any time including, for example, because of post market signals. Refer to Therapeutic Goods Act 1989 s41FJ.

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