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Substantial changes affecting a TGA conformity assessment certificate and Transfers of certificates

Guidelines for notifying the TGA

29 June 2017

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1. What is considered a substantial change?

Under section 41EJ of the Act, the manufacturer must notify the TGA of any plan for substantial changes to any of the following elements covered by a TGA issued conformity assessment certificate:

Changes to Quality Management Systems

The following are considered to be examples of substantial changes to a QMS.

Changes to the details on the TGA Certificate

For example, a change in:

  • name and/or address of the manufacturer
  • any details of the manufacturing facilities, including scope
  • any details of critical suppliers, including scope or addition or deletion of a supplier
  • the scope of products (device categories) covered by the certificate
  • the type of conformity assessment procedure applied - for example, changing from a Schedule 3, Part 4 (Production Quality Assurance Procedures) system to a Schedule 3, Part 1 (Full Quality Assurance Procedures) system.

Note

Sometimes a name change may be the result of a certificate transfer due to the disposal of a business, its amalgamation with another manufacturer, the death or bankruptcy of the owner, or the winding up of a business.

For these situations, please see: Transfers of conformity assessment certificates.

Changes to QMS processes

For example, changes to critical validated processes, in particular changes to a process where the validation is critical to mitigating risks related to that process. This is particularly important where the risks, if unmitigated, may have adverse effects on patients or users. Some examples are a change to:

  • sterilisation method (ethylene oxide (EO) to gamma, gamma to e-beam, etc.)
  • the critical parameters of the sterilisation process (e.g. biological indicator monitoring to parametric release for EO sterilisation, change in aeration or dwelling period for EO sterilisation)
  • a manufacturing process that might impact on pre-sterilisation bioburden
  • the location for a step in manufacturing (e.g. to a different manufacturing site or critical supplier)
  • a drug coating process
  • a viral inactivation process

Changes to the product range

A change to the kinds of medical devices to which the QMS has been applied must be notified to the TGA. Subsection 41EJ(3) of the Act, and the conformity assessment procedures in Schedule 3 of the Regulations, set out the requirements to notify such changes. The product range is specified in the scope of a QMS certificate under Device Categories.

Note

The MD Regulations specify that references to kinds of medical devices, in the context of conformity assessment procedures including changes, also include a reference to an individual medical device.

Changes to the product design of medical devices

This section applies to all medical devices and not just those kinds of devices that are subject to design or type examination procedures. The requirement under section 41EJ of the Act to notify the TGA of substantial changes to the product design of the medical device includes changes to the specifications and design details of the medical device that must be documented as part of a manufacturer's QMS. Following receipt of notification of the proposed substantial change, the TGA will determine the level of assessment necessary to verify that the device will continue to comply with the applicable provisions of the essential principles, and the conformity assessment procedures.

Note

It is not possible (or indeed appropriate) to specify what would be considered a substantial change for each of the vast range of medical devices on the market. Manufacturers must have change control procedures in place that consider the impacts of change and whether or not the change requires notification to the TGA.

Examples of substantial changes to the product design of medical devices include changes:

  • to the intended purpose which have not been previously assessed by the TGA, such as broadening the clinical indications, therapeutic use, patient groups or users
  • that are likely to introduce new hazards, alter the likelihood, severity, or detectability of harm, or consequences that were not previously documented by the manufacturer in their risk analysis and therefore likely to affect compliance with the essential principles
  • to the materials or formulations used in the medical device, particularly when they may impact the biological safety or the mechanical performance of the device
  • that may affect the sterile barrier integrity of a device, or its performance after storage, including changes to packaging materials or methods, changes to the shelf life, or changes to storage requirements (other than IVD medical devices)
  • to the sterilisation method that may impact the device integrity
  • to the species, origin or source of animal or microbial origin materials in medical devices (other than IVD medical devices)
  • to the supplier, manufacturing process, quantity or type of medicine incorporated in a medical device (other than IVD medical devices)
  • to the design, manufacturing or components of an IVD medical device that may change or affect its intended performance
  • to an IVD medical device for self-testing that may increase the risk of error in the use of the device, handling of the sample or interpretation of results, or that may increase the complexity of use of the device for the user.

Note

For IVD medical devices, extension to the claimed shelf life where the stability monitoring program has already undergone review and acceptance by the TGA, and when the design or acceptance criteria of the monitoring program have not changed, do not require notification. Such changes must be recorded for provision to the TGA if requested.

Changes to labelling and instructions for use

According to the Act and the MD Regulations, the intended purpose of a kind of medical device is ascertained from any one or more of the following:

  • information provided with the device (labelling)
  • instructions for use (IFU)
  • any advertising relating to the device
  • technical documentation describing the mechanism of action of the device.

In addition, the Essential Principles require some specific content to be included in the information provided with a device. This includes, among other things, the:

  • intended purpose and intended patient group for the device
  • conditions under which the device should be stored, and
  • warnings in relation to the use of the device.

Therefore, some changes to labelling and IFU are considered to be substantial changes. These include (but may not be limited to):

  • adding contraindications or other information regarding the safe use of the device
  • extending the IFU to include use in a different patient population
  • a labelling change from single use to re-usable
  • adding a new procedure for a use or purpose not originally assessed
  • changing the magnetic resonance (MR) compatibility status of a device
  • changing the storage conditions for a device whose performance may be impacted by these conditions
  • changing the name of the device.

Note

The IFU and labelling of a device can be an important part of the risk mitigation measures for using the device. If this information is changed, for example to add a contraindication, warning, or other important information about safe use of the device, the existing labelling and IFU, for devices already in the field, may need to be recalled in accordance with the Uniform Recall Procedure of Therapeutic Goods.

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