Reclassification of surgical mesh devices

On this page: Introduction | Timing | New medical device applications | Transitional provisions for pre-commencement entries | Kind of device | Preliminary assessment - Requirements for Class III applications for ARTG inclusion | Fees and charges associated with reclassification | Device reclassification - amendments to Prostheses list | Questions and answers

Introduction

This guidance is for sponsors of surgical mesh medical devices, and to assist the TGA's assessors when dealing with device applications and entries affected by the re-classification requirements.

If you import and/or supply these devices, you need to know about the regulatory changes that will impact your product.

The Australian Government has strengthened the assessment of surgical mesh medical devices by approving regulatory amendments that reclassified all these medical devices from Class IIb (medium) to Class III (high risk).

This decision is consistent with the recommendations from the Expert Review of Medicines and Medical Devices Regulation (MMDR) to align (wherever possible) the Australian classification of medical devices with the European Union framework.

The Australian Government has made the decision to reclassify surgical mesh devices ahead of Europe due to the serious concerns about risks associated with the use of these devices.

The Therapeutic Goods Administration (TGA) announced the regulatory amendments on 26 October 2017. The Therapeutic Goods (Medical Devices) Amendment (Implantable Medical Devices) Regulations 2017 provide that from 1 December 2018, surgical meshes are classified as Class III medical devices as follows:

Surgical mesh

Surgical mesh medical devices are a variety of surgical implants usually used in the repair of soft tissue, or mixed soft tissue/bony structural defects, to support organs and/or tissues or to strengthen the integrity of a body cavity. Surgical mesh is implanted in the body for repair or reinforcement, and includes tapes and slings.

Surgical mesh devices can be used in a range of anatomical locations and structures. These include, but are not limited to, repair and/or support to tissue and/or organs of the perineum, urethral structures, pelvis, abdomen, breast, and soft tissue of the inguinal, femoral, and ventral regions. Surgical mesh devices are also used in ligaments, tendons, and other periarticular tissue in repair and/or support.

They may be constructed from a range of absorbable or non-absorbable materials (e.g. metallic mesh, flexible synthetic or organic materials etc.), may have different forms (e.g. solid sheet, matrix, woven or knitted, etc.) and shapes (e.g. sheet, sling, tape, etc.).

Surgical meshes are generally designed to be integrated into the structures they support. The primary mechanical function can be either unidirectional (longitudinal) tensile strength or multi-directional support or strength.

Examples of surgical mesh medical devices

1. Hernia surgical mesh
   Types of Hernias: Inguinal - occurs in the inner groin; Femoral - occurs in the upper thigh/outer groin; Incisional - occurs through an incision or scar in the abdomen; Ventral - occurs in the general abdominal/ventral wall; Umbilical - occurs at the belly button; Hiatal - occurs inside the abdomen, where the stomach pushes up through the diaphragm.
2. Urogynaecological surgical mesh (most commonly indicated for pelvic organ prolapse and stress urinary incontinence)
3. Male sling (Stress urinary incontinence)
4. Surgical mesh used in orthopaedic and trauma reconstructive surgeries (e.g. synthetic mesh for tendon repair, tissue approximation during reconstruction of damaged or torn ligaments, tendons or other soft tissues)
5. Synthetic or biological surgical mesh patches used in plastic and reconstructive surgery (e.g. mesh intended acting as a barrier hindering the migration of the cells and tissues, support devices in breast surgery)
6. Abdominal plugs made from mesh

Timing

Actions to consider

New medical device applications

Any application for inclusion of a surgical mesh in the Australian Register of Therapeutic Goods (ARTG), submitted to the TGA on or after 1 December 2018, must be submitted as an application for a Class III medical device.

Transitional provisions for pre-commencement entries

Devices to which transitional provision will apply

Sponsors will be able to access the transitional provision only if the following requirements are met:

1. Only sponsors who have pre-commencement entries are able to access the transitional provisions. A pre-commencement entry is an ARTG inclusion of any 'kind of medical device' that is:
   • included in the ARTG as a Class IIb medical device following assessment of an application made before 1 December 2018, and
   • regardless of whether the commencement date for the ARTG entry was before or after 1 December 2018.
2. The application for appropriate TGA conformity assessment certificate for the individual devices covered under the Class IIb entry has been submitted between 1 July 2020 and before 1 December 2021, or
3. The application for appropriate TGA conformity assessment submitted between 1 July 2020 and 1 December 2021, is not withdrawn before 1 December 2021, has not lapsed, and if the certificate was issued before 1 December 2021 it was within 6 months of 1 December 2021; and
4. An application for inclusion as Class III medical device is submitted within 6 months after the TGA conformity assessment certificate is issued.
5. An application for inclusion has not been made for the kind of medical device that is currently under assessment in the application for appropriate TGA conformity assessment.

Application for inclusion of the surgical mesh in ARTG as Class III

After you obtain a valid conformity assessment certificate, you will be required to submit applications for inclusion of your surgical mesh devices in the ARTG as Class III medical devices prior to the end of the transition period:

• For urogynaecological mesh: by 1 December 2020.
• For all other surgical mesh: After the earlier of either:
  • The day the TGA conformity assessment application is withdrawn;
  • The day the application for appropriate TGA conformity assessment application lapses;
  • The day a decision to refuse issuing a TGA conformity assessment certificate for the kind of medical device in the application becomes final and is no longer subject to appeal; or
  • Within six months of the conformity assessment certificate being issued.

Examples of how the transitional provision will apply

Example A: Other Surgical Mesh Device

1. Submit an application for appropriate TGA conformity assessment certificate for all three devices of the kind you have in your Class IIb ARTG entrybefore 1 December 2021

   OR

2. Submit three Class III applications for inclusion of each individual surgical mesh (individual UPI) in ARTG by no later than 1 December 2021 or up to six months after the date of issue of a TGA conformity assessment certificate for the surgical mesh.

If you meet either requirements within the specified timeframes, you may continue supplying your devices in Australia until all your respective Class III applications are finalised.

If your Class III applications are successful, your respective surgical mesh devices will be re-included in the ARTG as three individual Class III medical device entries.

After you receive notifications of your new Class III ARTG entries, you may request TGA to cancel your related Class IIb ARTG entry. Otherwise, TGA will make a decision regarding cancellation of your Class IIb ARTG entry on our own initiative.

If one (or all) of your Class III applications for inclusion in the ARTG or for TGA conformity assessment is/are unsuccessful (lapsed, withdrawn, or a decision is made not to include the device in ARTG, or the TGA refuses to issue a conformity assessment certificate for the device), or after the TGA conformity assessment certificate is issued and , you will no longer be able to supply the device(s) in Australia.

The TGA will make a decision regarding the cancellation of your respective Class IIb ARTG entry.

Example B: Other Surgical Mesh Device

After you have received your ARTG entry, you may start importing and supplying your medical device(s).

However, in order to continue to be eligible for the transitional provision, you must:

1. Submit an application for appropriate TGA conformity assessment certificate before 1 December 2021;

   OR

2. Submit a Class III application for inclusion of each individual surgical mesh (individual UPI) in the ARTG before 1 December 2021 or no later than six months after the date of issue of conformity assessment certificate.

For the remaining part of the process, refer to Example A.

Kind of device

Only devices of the same kind can be supplied under one ARTG entry.

Class IIb medical devices

Class IIb devices are taken to be of the same kind as another medical device if these devices:

• are supplied by the same sponsor;
• are manufactured by the same manufacturer;
• have the same medical device classification; and
• have the same Global Medical Device Nomenclature (GMDN) System Code.

Class III medical devices

In addition to the above characteristics, devices of the same kind must have the same unique product identifier (UPI).

Preliminary assessment - Requirements for Class III applications for ARTG inclusion

For a Class III medical device application to pass preliminary assessment:

• The application must be made electronically via the TGA Business Services (TBS) client's portal.
• It must be made in accordance with a form and manner approved for the classification of a medical device (there are separate forms approved for different classifications and as the sponsor, you must select correct form for the Class III device). For further information, go to Application requirements for medical devices - preliminary assessment.
• The application fee must be paid.
• The application must be accompanied by the kind of information prescribed for the application of this classification by legislative instrument and provided in an approved form.
  • You must have the appropriate conformity assessment documents demonstrating the application of the conformity assessment procedures or comparable procedures to the device and provide these documents with the application for inclusion of your medical device in ARTG. For further information, go to Application requirements for medical devices - preliminary assessment.
• For devices that must have a TGA conformity assessment certificate - such certificate is in force; and
• The applicant must certify the section 41FD matters.

Conformity assessment documents

For the purposes of applications for ARTG inclusion of Class III medical devices, the TGA will consider documents issued by:

• Notified Bodies designated under European Union medical device regulatory frameworks;
• United States Food and Drug Administration (FDA);
• Health Canada;
• Relevant Japanese authorities (the Ministry of Health, Labour and Welfare (MHLW), Pharmaceutical and Medical Devices Agency (PMDA) or Registered Certified Body (RCB), whatever is applicable); or
• Medical Device Single Audit Program (MDSAP) Auditing Organizations (AO).

The conformity assessment procedures, or comparable procedures, set out the requirements relating to the application of manufacturers' quality management systems for medical devices and other requirements imposed on manufacturers, specifically in relation to the design and production of medical devices.

Conformity assessment procedures that must be applied to a Class III medical device intended by the manufacturer to be supplied sterile are either:

• the full quality assurance procedures (including design-examination); or
• the type examination procedures and the production quality assurance procedures (Regulation 3.6(2) of the Therapeutic Goods (Medical Devices) Regulations 2002).

Respectively, examples of conformity assessment documents that are prescribed for Class III applications for inclusion of medical devices in the ARTG are any of the following^[2]:

• TGA conformity assessment certificate issued either under Part 1 (including Clause 1.6), or under Part 4 and Part 2 of Schedule 3, Therapeutic Goods (Medical Devices) Regulations 2002; OR
• EC Certificate issued by notified body within the meaning of Council Directive 93/42/EEC either under Annex II (including section 4), or under Annex V and Annex III; OR
• EU quality management system certificate issued either under Chapter I of Annex IX and EU technical documentation assessment certificate issued under Chapter II of Annex IX, or production quality assurance certificate issued under Part A of Annex XI and EU type-examination certificate issued under Annex X, issued by a notified body within the meaning of the EU medical devices regulation; OR
• MDSAP certificate or a quality management system certificate for the purposes of the Japanese PMD Act, and a pre-market approval issued under the Japanese PMD Act; OR
• MDSAP certificate and Class IV medical device licence issued under the Canadian medical devices regulations; OR
• MDSAP certificate and an order approving an application for premarket approval under section 515 of the US FDC Act (PMA).

Audit assessment of Class III applications

Applications for ARTG inclusion of Class III medical devices (for which a TGA-issued conformity assessment certificate is not in force) must be selected for audit.

The level of audit (Level 1 or Level 2) may depend on the category of a medical device and the overseas regulator conformity assessment document(s) provided with the application.

When your application is selected for audit, you must provide all the necessary information to demonstrate compliance with the essential principles to the TGA for assessment when requested. At minimum, you will be required to provide:

• labelling
• instructions for use
• manual and product brochure, and
• clinical evidence for the device.

Sponsors can submit requests with their applications requesting abridgement of the audit assessment (including requests to abridge the level of audit if appropriate):

• Sponsors are required to provide justification supporting their requests, and
• TGA's delegate will decide whether such request is appropriate

Guidance on requests for abridged assessment is available on the TGA website.

Example of 'level of audit' decision

Level of application audit: A decision on the audit level is based on information provided in the application and/or information or signals that the TGA has regarding the device (or similar devices):

• The application will be selected for Level 2 audit if:
  • The device does not appear to be the same as the device specified in the PMA (including differences in the UPI, design, intended purpose or clinical indications); or
  • There are other signals that raise safety or performance concerns.

• The application will be selected for Level 1 audit if:
  • None of the criteria for Level 2 audits apply, the application will usually undergo a Level 1 audit.

Fees and charges associated with reclassification

The Class III application fee and compulsory audit assessment fee will be applicable to all Class III applications for surgical mesh medical devices.

If the device is included on the ARTG, Class III annual charges will apply. Please refer to the TGA's website for the relevant fees and charges.

Device reclassification - amendments to Prostheses list

Some sponsors list their devices on the Prostheses List in order for the devices to be reimbursed by private health insurers.

When the TGA reclassifies a medical device, a new ARTG entry is assigned.

If your Class III ARTG inclusion application is successful and you received a new ARTG entry, you will be required to update your Prostheses List listings in order to remain on the Prostheses List.

Failure to maintain the currency of 'Billing code' details in the Prostheses List may result in discrepancies between private hospital records and the Prostheses List. These discrepancies may result in benefits not being paid by private health insurers.

To update the Prostheses List with your new ARTG numbers, you will need to submit an Amendment Application using the Prostheses List Management System (PLMS) for each of the affected Billing codes. When submitting an Amendment Application, please ensure that you clearly advise the reason for the change and include relevant supporting documents that clearly identify the required changes.

Examples of supporting documentation include:

• New ARTG certificate; and
• Catalogues (with any changes highlighted).

For any queries about amending your Billing code on the Prostheses List, please contact the Prostheses Hotline (02) 6289 9463 or email: prostheses@health.gov.au.

Questions and answers

What will happen after successful completion of the assessment of my Class III application?

If your application(s) for reclassification of surgical mesh devices are successful, and all your devices are included in ARTG as Class III, you will no longer require a Class IIb ARTG entry and this entry may be cancelled.

We encourage you to request cancellation as soon as possible to prevent paying unnecessary annual charges. Otherwise the TGA may make a decision regarding cancellation on our own initiative.

What will happen if my Class III application is not successful?

If your Class III application is not successful, you will be notified of the decision in writing and you will be provided the reasons for the decision.

If you are not satisfied with this decision, you may request reconsideration of this initial decision under section 60 of the Therapeutic Goods Act 1989 within 90 days of the decision.

If you are not satisfied with the reconsideration (reviewable decision), you may apply to the Administrative Appeals Tribunal or the court.

Once the final decision regarding your Class III application is made (i.e. it is finally determined^[3]), the TGA will make a decision regarding cancellation of your related Class IIb ARTG entry.

Can I continue supply of my surgical meshes in Australia after the end of the transitional period if the audit assessment of my Class III application is not finalised?

You can continue supply of your devices under the Class IIb ARTG entry until the decision on your Class III application(s) is made, or if the application is withdrawn or has lapsed, if you:

• have submitted an application for appropriate TGA conformity assessment certificate before 1 December 2021;
• submitted Class III ARTG inclusion application(s) before 1 December 2021, or within six months of the date of issue of the TGA conformity assessment certificate for the kind of device; and
• your Class III application for inclusion in the ARTG or appropriate application for TGA conformity assessment certificate for the individual devices covered under the Class IIb entry submitted between 1 July 2020 and before 1 December 2021 is still under assessment by the TGA.