6. Registration Processes

Medical Devices Class I & II
Australia

This section provides information on any product notification or registration and manufacturing site registration processes.

6.1 Product Notification

Variation to an Included Medical Device - all Classes - is necessary should a substantive change to the approved Intended Purpose be necessary. The definition of ‘substantive change’, however, is vague.

The legislation (Regulations) provides the following information regarding the necessity for variations to an approved medical device:

• a ‘variant’ of a medical device is where the design of which has been varied, to accommodate
  • different patient anatomical requirements (for example, relating to the shape, size, length, diameter, or gauge of the device), or
  • any other variation approved by the Secretary for this definition, if the variation does not change the intended purpose of the device.

If the intended purpose of the device is to be varied, then a new product application is required.

6.2 Product Registration

“Product registration” is not the term used for medical devices in Australia. Applications to have medical devices “Included” in the ARTG is the terminology used.

A Manufacturer's Evidence application must be submitted and accepted by the TGA before the lodgement of most medical device product applications for Inclusion in the ARTG.

Medical Devices - all Classes - are required to be submitted to the TGA and can only be supplied into the Australian market under one of the approval schemes defined for those purposes (e.g. Medical Device Inclusion process, Special Access Scheme).

Primarily, medical devices are first Included in the ARTG as an outcome of submitting a medical device product application (online via the TBS* portal) for evaluation of the medical device.

The evaluation depth corresponds to the Class. For example, Class I receives an abbreviated assessment of the Declaration of Conformity whereas a Class IIa or IIb will receive a deeper evaluation of areas such as Conformity Assessment details, labeling, intended purpose, construction, formulation, biocompatibility, sterility processes and such, as applicable to that type of medical device.

*TGA Business Services

6.3 Other Notes or Requirements

Currently, Australian regulation for medical devices is undergoing significant revision. The TGA is undertaking alignment with the European Union Medical Devices Regulation (EU MDR).

Most medical devices supplied in Australia, included on the ARTG, have been evaluated and supported by certification obtained under the previous European Union Medical Devices Directives (EU MDD). As those EU MDDs are now repealed, all medical devices will need to transition to the requirements of the European Union Medical Devices Regulation (EU MDR).

Additionally, the Therapeutic Goods (Medical Devices) Regulations are also under review at the date of publication of this document.

New Medical Device applications for Inclusion in ARTG will require alignment with the EU MDR to the extent required by the Australian Regulations.

Australian Criteria for “A Kind of Medical Device”

Under the Act, a 'kind of medical device' [1] must be included in the ARTG prior to supply in Australia unless an exemption applies. For example, custom-made medical devices, which are regulated under the Act, are exempt from the requirement to include them in the ARTG.

The criteria for a “kind of medical device” depend on its classification, as described below.

A. Lower-risk devices

For lower classifications, a 'kind of medical device' is a broader concept and covers a range of similar products which have:

• Same sponsor
• Same manufacturer
• Same classification
• Are described by the term of the same Global Medical Device Nomenclature (GMDN) code

For example, a single ARTG entry may cover a range of different models or brands of similar devices, such as the multiple variations in the formulation of a silicone scar gel from the same manufacturer and sponsor.

A new ARTG Inclusion is required if a kind of medical device:

• changes to a new manufacturer,
• receives a new Intended Purpose,
• has a new GMDN code assigned that does not specifically and only replace an outdated or replaced code,
• has its classification reassigned by the manufacturer or regulator, or
• has a functional characteristic or significant formulation change that might affect an existing intended patient population.

For the purposes of this section, some basic examples of Low-Risk medical devices and current Classes applicable are shown in the below table. These are indicative only and the final Classification of other Medical Devices types must be determined by application and assessment against the legislative criteria current at that time.

B. High-risk devices including Class III

Not in the scope of this Guidebook.

6.4 Manufacturing Site Registration

In Australia, the Therapeutic Goods Act 1989 requires, with certain exceptions, that manufacturers of therapeutic goods - medical devices – obtain and hold a current Conformity Assessment certificate.

The manufacturers must apply conformity assessment procedures (or requirements comparable to conformity assessment procedures) that are appropriate to the kind of device. The usual ways to demonstrate this include:

1. conformity assessment certification issued by the TGA
2. conformity assessment certification issued by an Australian conformity assessment body
3. conformity assessment documentation issued by a comparable overseas regulator

Conformity assessment is the systematic and ongoing examination of evidence and procedures to ensure that a medical device (including IVD medical devices) complies with the Essential Principles.

A manufacturer's evidence application must be submitted and accepted by the TGA before the lodgement of most medical device product applications for inclusion in the ARTG.

Category

All medical devices

6.4.1 Standard/Rules for Manufacturing Site

Category

All classes of Medical Device - manufacturers must have a Quality System for medical devices implemented.

Typically ISO 13485 is the default Standard though other certifications issued might be acceptable (e.g. US FDA - Title 21 CFR 820).

Note: Chinese Manufacturing Standards for Quality Systems for Medical Devices (equivalents) ARE NOT acceptable in Australia.

Mutual Recognition Agreement (MRA) - an external site in place between Australia and the European Community - provides for the mutual acceptance of conformity assessment for medical devices. This agreement provides for recognition of: the TGA conformity assessment certification issued under the European medical device (93/42/EEC - external site) and active implantable medical device (AIMD) (90/385/EEC - external site) directives conformity assessment certification issued by an appropriately designated European notified body under the Therapeutic Goods Act 1989 - external site (and the related regulatory framework).

Product

Any valid medical device.

6.4.2 Other Notes or Requirements for Manufacturing Site Registration

The following documentation is acceptable Manufacturer Evidence [2] to TGA, depending on the class of the device:

• A TGA Conformity Assessment Certificate – issued by the TGA Conformity Assessment Branch.
• Overseas market authorization evidence or conformity assessment document relating to the manufacturer’s quality management system from a comparable overseas national regulatory authority*.
• Declaration of Conformity [3] to clause 7.5 of Schedule 3 of the Regulations for a system or procedure pack which might include a mixed classification of medical devices.

* Overseas Market Authorization evidence is currently accepted by regulators and other approved entities as follows:

1. 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.
2. Decisions of the United States Food and Drug Administration (FDA).
3. Approvals and licenses issued by Health Canada.
4. 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).
5. Registrations of the Singapore Health Sciences Authority (HSA).
6. Certificates and reports issued under the Medical Device Single Audit Program (MDSAP).
7. ISO 13485 certificates issued by a certification body that is also a Notified Body designated under the IVDD 98/79/EC, along with EU Declaration of Conformity made by the manufacturer before 26 May 2022 under Annex III of IVDD 98/79/EC (for Class 2 IVD applications submitted before 26 May 2027 and Class 3 IVD applications submitted before 26 May 2026).
8. ISO 13485 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) along with the EU Declaration of Conformity made by the manufacturer before 26 May 2022 under Annex III of IVDD 98/79/EC (for Class 2 IVD applications submitted before 26 May 2027 and Class 3 IVD applications submitted before 26 May 2026).

Category

All Classes of Medical Devices.

Product

Any valid medical device.

6.5 References

1. What 'kind of medical device' is it | Therapeutic Goods Administration (TGA) 

2. Manufacturer Evidence for medical devices

3. Declaration of Conformity