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

Guidelines for notifying the TGA

29 June 2017

The purpose of this guidance is to help manufacturers understand how the TGA interprets regulations, and thus indicate how a manufacturer 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.

Overview

This guidance is for manufacturers that have been issued conformity assessment certification by the Therapeutic Goods Administration (TGA) and are planning to make a change. This guidance also includes events that trigger a transfer of a conformity assessment certificate, and its associated responsibilities, to a new entity.

This guidance is not about urgent changes that require recall action.

These types of changes should begin with a notification to the TGA under the Uniform Recall Procedure for Therapeutic Goods.

If a manufacturer has been issued with a conformity assessment certificate by the TGA, both the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations) require manufacturers to notify the TGA about any plans for 'substantial changes', as these need to be assessed by the TGA before they are introduced.

This guidance has been prepared to assist manufacturers in deciding what is considered to be a 'substantial change' that would require notification to the TGA under the conformity assessment procedures.

For any change, whether substantial or not, manufacturers are expected to:

  • have written procedures as part of their Quality Management System (QMS) to cater for change management, and to guide their related decision making, and
  • consider the impact of changes on regulatory requirements and risk management, and
  • document the details and analysis of changes so that the records will be available if requested by the TGA.

This guidance is only applicable to TGA-issued conformity assessment certificates.

If sponsors rely on conformity assessment certification issued by one of the European Notified Bodies (NBs) to support their ARTG entries, it is expected that substantial changes should be reported to those NBs for assessment.

The NBs will have their own procedures for assessing change, and re-issuing certificates if necessary. See Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System.

If the changes result in the reissue of a NB QMS certificate (or a new NB QMS Certificate) the sponsor should notify the TGA about this event via an application for variation to manufacturer's evidence.

If the changes assessed by the NB affect the information entered on the ARTG in relation to the device, e.g. changes to the intended purpose, changes to the functional description, changes to variants, etc., the TGA should also be notified through the ARTG variation process.

1. What is considered a substantial change?

Guidelines for notifying the TGA

29 June 2017

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.

2. What is not considered a 'substantial change'

Guidelines for notifying the TGA

29 June 2017

The following categories of changes illustrate some of the types of changes which would not be considered by the TGA as substantial, and therefore would not require notification (there may be others):

  • changes to non-critical parts or suppliers that can be demonstrated to still meet the acceptance criteria established by the manufacturer
  • changes to manufacturing equipment or processes which are not likely to influence the level of risk to the user or patient
  • changes to the artwork, colour, font, or layout of the packaging and labelling of a medical device that does not alter compliance with Essential Principle 13.

Although notification is not required for the above changes, the MD Regulations require the manufacture to ensure they continue to meet the requirements of their QMS.

The manufacturer must maintain documentation of any changes as part of the QMS for traceability and recordkeeping purposes. Documentation of the changes must be provided for review by the TGA if requested, for example at an on-site inspection.

Examples of substantial changes that require notification to the TGA are provided in Appendix A.

3. Transfers of conformity assessment certificates

Guidelines for notifying the TGA

29 June 2017

Transfers of a conformity assessment certificate to a new person or body corporate as a result of certain events are required to be notified to the TGA within 3 months following the transfer.

Note

You still need to notify us of any substantial changes (other than a name change) made in relation to a certificate transfer.

Ensure you notify us (in accordance with this guideline) prior to the substantial change(s) being implemented to allow time for the TGA to assess them.

Events that trigger a transfer

Division 4.3 of the MD Regulations applies to a manufacturer of a medical device in respect of whom a conformity assessment certificate is issued, and includes provisions about when a conformity assessment certificate is taken to be transferred to a new person or body corporate.

The MD Regulations state that such transfers occur where the manufacturer:

The manufacturer dies, becomes bankrupt, or is wound up

Regulation 4.6 of the MD Regulations provides that in this case:

  • the personal legal representative, trustee in bankruptcy or liquidator, as the case may be, is taken to be the person in respect of whom the certificate is issued (i.e. the new holder); and
  • the new holder must notify us of that event within 3 months of it occurring; and
  • provide us with sufficient documentary evidence of the relevant event (MD Regulation 4.10).

Disposal of business or amalgamation with another manufacturer

Regulation 4.7 of the MD Regulations provides that where the name of the manufacturer changes because either:

  • the manufacturer agrees to dispose of a business concerned with the manufacture of the medical device and it is agreed that the disposal is to include the transfer of the relevant conformity assessment certificate; or
  • the manufacturer, being a body corporate, amalgamates with another body corporate under a different name;

then

  • the person to whom the business is disposed of, or body corporate with whom the manufacturer amalgamates is taken to be the person in respect of whom the certificate is issued (i.e. the new holder); and
  • the new holder must apply for the name of the manufacturer to be changed on the conformity assessment certificate within 3 months of it occurring; and
  • provide us with sufficient documentary evidence of the relevant event (MD Regulation 4.10).

Manufacturer changes its name

Regulation 4.8 of the MD Regulations states that if the name of the manufacturer is changed, the manufacturer (as renamed) is taken to be the person in respect to whom the certificate was issued, and requires the manufacturer of the medical device to:

  • notify us within 3 months of a change of its name, and
  • provide us with sufficient documentary evidence of the relevant event (MD Regulation 4.10).

Examples of events that result in transfers that require notification to the TGA are provided in Appendix B.

When does the transfer actually take place?

The TGA does not make a determination as to when the transfer actually takes place. This is determined by the timing of the relevant event (e.g. the bankruptcy) as set out in Division 4.3 of the MD Regulations.

Once an event occurs, the new person or business is taken to be responsible for meeting the requirements related to the conformity assessment certificate, regardless of whether the TGA has:

  • been notified of the transfer or change, or
  • updated the relevant TGA conformity assessment certificate.

If a conformity assessment certificate is transferred because of the operation of Regulation 4.6, 4.7, or 4.8:

  • the legal and regulatory responsibilities transfer to the new holder of the certificate; and
  • the new holder can continue to produce the medical device(s) covered by the certificate while the certificate remains valid.

Manufacturers (and prospective new manufacturers) should get their own advice about:

  • the impact of MD Regulations 4.6, 4.7 and 4.8 on their status; and
  • their obligations under the Therapeutic Goods Act 1989 and its associated regulations when a conformity assessment certificate is transferred.

Note

If the TGA becomes aware that we have not been notified of an event that triggers a certificate transfer, we may suspend or revoke the conformity assessment certificate to which the event relates.

4. Notification of substantial changes and transfers

Guidelines for notifying the TGA

29 June 2017

For notification of a substantial change

Substantial changes must be notified and assessed by the TGA prior to supplying any products (kinds of devices) affected by those changes.

Notification of a substantial change is done via the TGA Business Services (TBS) portal using the standard conformity assessment application form. For guidance on how to do this, please go to: Application for conformity assessment certificates.

Note

  • On the first page of the TBS application form, ensure you select the option for change to an existing certificate.
  • In the Applicant's reference field, ensure you include: Substantial change to conformity assessment certificate.

What happens after you submit a notification

Following the receipt of an application for a substantial change, the TGA will contact the applicant (the manufacturer or their representative) if additional information is required to assess the change.

Manufacturers should allow adequate lead time for the TGA to consider and complete the assessment of the proposed changes before they occur. The assessment may require an on-site inspection which will be incorporated into the TGA's inspection schedule.

For notification of a certificate transfer

Notification of a conformity assessment certificate transfer is done via the TGA Business Services (TBS) portal using the standard conformity assessment application form. For guidance on how to do this, please go to: Application for conformity assessment certificates.

MD Regulation 4.10 states that if a person is required to notify the TGA of an event that results in transfer of conformity assessment certificates, the person must also provide us with sufficient documentary evidence of the relevant event (e.g. evidence of amalgamation of a business, evidence of the bankruptcy of a manufacturer, etc.).

Transfers must be notified to the TGA not later than 3 months after the change has taken place.

Note

  • On the first page of the TBS application form, ensure you select the option for change to an existing certificate.
  • In the Applicant's reference field, ensure you include: Transfer of conformity assessment certificate.
  • Please complete and include the Transfer of conformity assessment certificates form as part of your supporting evidence.

Appendix A: Examples of substantial changes

Guidelines for notifying the TGA

29 June 2017

Some of the examples below have been modified from the US FDA's draft guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device: Draft Guidance for Industry and Food and Drug Administration Staff (August 2016).

This draft guidance is available from the US FDA's Draft Guidance Documents page.

Labelling, instructions for use and packaging

  1. The Instructions for use (IFU) of a medicated balloon catheter are updated to provide instructions on how to access different vessel types that were not previously addressed in the labelling or IFU. This would change the intended use of the device and hence this is a substantial change that requires notification to the TGA and assessment.
  2. The manufacturer changes the supplier of the polyethylene packaging of their sterile devices; the packaging configuration and specifications remain the same. The manufacturer uses the same package integrity test protocols as that previously approved and an analysis shows the new packaging has no impurities that could affect the devices' biocompatibility. This is not likely to require a substantial change notification to the TGA but it is still a requirement of the Regulations that after any change the manufacturer must ensure its devices continue to meet the requirements of their QMS and the Essential Principles. Documentation of the change would be required and may be followed up for review at a subsequent TGA QMS Inspection. The Technical file for the product should also be updated.
  3. The manufacturer removes a contraindication that has been previously stated for the medical device in the IFU, without making any changes to the device. As this change effectively broadens the indications for the device, this is a substantial change that requires notification to the TGA and assessment. This is also the case if a manufacturer adds a new indication to the IFU.
  4. The manufacturer removes a precaution and/or warning that has been previously stated for the medical device in the IFU, without making any changes to the device. As this change impacts the mitigation of risk, this is a substantial change that requires notification to the TGA and assessment.
  5. The IFU for a pacemaker lead states that the device is safe for conditional use within MR-environments of up to 1.5T. The manufacturer has performed additional testing on the device and test results have shown that the device can be conditionally used within MR-environments of up to 3T. The manufacturer would like to change the IFU to reflect this new information. Given that exposure to higher magnetic field strengths is likely to introduce new risks, this is a substantial change that requires notification to the TGA and assessment.
  6. The manufacturer decides to add certified foreign language translations of the labelling and IFU for use in other regulatory jurisdictions, while no change is to be made to the content of the approved product labelling. Since this change is unlikely to introduce new risks associated with the use of the device, notification to the TGA would not be necessary, but the change should be recorded in the QMS documentation.
  7. After clinical investigations, the manufacturer of a dermal filler decides to add recommendations for use of a certain type of cannula in their IFU as part of the surgical procedure. The manufacturer clarifies that this cannula will not be packaged together with the product, however, this change is likely to be substantial since the new operation procedure or technique will involve specific training and verification. This is a substantial change that requires notification to the TGA and assessment.
  8. Due to real-time aging data becoming available (or further accelerated-aging testing), the manufacturer of a drug-coated stent intends to extend the product shelf-life from 12 months to 24 months. This is a substantial change to the packaging and shelf life of the medical device that requires notification to the TGA and assessment.
  9. The storage temperature of the medical device has changed due to new stability data becoming available. No other changes have been made to the device. This change may possibly affect device performance and hence this is a substantial change that requires notification to the TGA and assessment.
  10. A change in labelling and/or IFU of the medical device to add a statement that the device is non-pyrogenic or endotoxin free. This is a substantial change that requires notification to the TGA and assessment.
  11. The manufacturer decides to change the Unique Product Identifier of the medical device with no other changes to the device, which will result in changes to the device labelling and IFU. This is a substantial change that requires notification to the TGA and assessment.

Design change

  1. A stent manufacturer adds a stent with a larger diameter to a family of coronary stents. This stent diameter is outside the range of the previous approved variants for the stents. Substantial Change notification to the TGA and assessment would be required as the larger diameter could significantly affect device related safety and efficacy. However if the change in diameter was within the previous variant range and there was no other change (i.e. to length of stent) then notification would not be required but documentation of the change to the QMS system and updating of the product technical file would be required.
  2. The manufacturer of a coronary stent increases the thickness of the wire in the stent to reduce the potential for stent fracture. The thickness is important to the performance of the stent and could affect the safety or efficacy of the device. This is a substantial change that requires notification to the TGA and assessment.
  3. The manufacturer of a hemi-arthroplasty femoral stem/head changes the taper/bore angle of the device. Given that this change is likely to affect the biomechanics of the joint replacement device and hence the performance of the device this is considered a substantial change that requires notification to the TGA and assessment.
  4. The manufacturer of a biological surgical repair mesh intends to add an additional manufacturing stage to provide surgeons with pre-cut meshes. This cutting work is currently being done by surgeons in theatre during operations. Given that this design change involves adding a manufacturing process that has not been previously assessed, this is considered a substantial change that requires notification to the TGA and assessment.
  5. The manufacturer of a medical device alters some of the sterilisation process cycle parameters such as process temperature or load size – with no changes to any other aspects of the device. This is considered a substantial change that requires notification to the TGA and assessment since this change is likely to affect the quality and safety of the final product.
  6. The manufacturer decides to change the sterilisation method for the medical device from gamma irradiation to EO without changing any other aspects of the device. The safety of the ethylene oxide residuals remaining on the medical device is of concern, along with potential temperature effects from the sterilisation cycle, and a substantial change application would be required for assessment of this change by the TGA.
  7. The manufacturer of a device intends to implement design changes that are driven by recent changes in the standards that were originally used to demonstrate compliance, or due to recent post-market data becoming available. Since such changes are likely to affect the device safety, performance, and quality this is considered a substantial change that requires notification to the TGA and assessment.
  8. The manufacturer of a hip implant intends to reduce the design tolerances enabling them to manufacture the devices closer to their design specifications without introducing new design features. Since the tightening of acceptance criteria is not expected to raise any new risks and issues, this is not likely to require a substantial change notification to the TGA. However, it is still a requirement of the Regulations that after any change the manufacturer must ensure they continue to meet the requirements of their QMS and the Essential Principles. Documentation of the change would be required and may be followed up for review at a subsequent TGA QMS Inspection. The Technical file for the product should also be updated.
  9. During research and development processes, the manufacturer of an approved active implantable device has found new software algorithms that improve the devices' function and usability. This change requires new design validation and verification; therefore, this is a substantial change that requires notification to the TGA and assessment. If the software only affected the graphical user-interface of the device, notification would not be required.
  10. Using previously approved manufacturing processes, the manufacturer of an intraocular lens (IOL) has made slight changes in the haptic geometry of the IOL. The optical performance specifications of the device have not been changed. However, since such changes are likely to affect the device performance and interaction with internal tissues this is a substantial change that requires notification to the TGA and assessment.

Material change

  1. The manufacturer of a Balloon Catheter changes the material of the polymer tubing used to manufacture the catheter from polymer A to polymer B and the manufacturer has not previously used polymer B (even if there were other similar devices on the market with polymer B). The manufacturer would have no knowledge of the formulation or manufacturing processes of polymer B tubing in the competitors' devices and would be required to assess the biocompatibility and performance of polymer B tubing in its own catheter. This is a substantial change that requires notification to the TGA and assessment. However, if the manufacturer has used polymer B tubing, with the same formulation and processing, in another previously approved catheter with the same type and duration of body contact and the same performance specifications then it may be acceptable to document the change to the QMS and update the technical file only.
  2. The manufacturer of a drug-eluting stent changes the supplier that provides the medicinal substance used in the device. The manufacturer is required to provide evidence (such as Letter of Access for an existing Drug Master File and/or Certificate of Suitability) to support the quality and safety of the medicinal substance used in the device as well as documentation to support the manufacturer's control over the new supplier. This is a substantial change that requires notification to the TGA and assessment.
  3. The manufacturer of a transvenous catheter system decides to change the materials of the guide wire that is supplied with the system. As the guide wire would be in direct contact with the circulatory system, the change in material is likely to affect the biocompatibility of the device; and, the quality and safety of the new materials requires assessment and any impact on performance should be considered. This requires a substantial change notification to the TGA and assessment.
  4. The manufacturer intends to change the sodium hyaluronate raw material specification to accommodate changes proposed by the raw material supplier and validation test results have shown there is an impact on the quality, performance and specification of the finished medical device. This is a substantial change that requires notification to the TGA and assessment. However, if validation test results have demonstrated that the change to the raw material specification have no impact on the quality, performance and specification of the finished medical device, a substantial change application would not be required but the manufacturer should document the changes in the QMS; and the Technical file for the product should be updated.

IVD change

  1. A Manufacturer makes a change to an inactive reagent included in the formulation of an IVD as a result of a change in supplier. The raw material specifications for the replacement reagent are equivalent to the previous reagent. Results of the risk analysis and verification and validation studies conducted by the manufacturer do not indicate any new safety or performance concerns. The manufacturer should document the changes and relevant tests in the QMS; and the Technical file for the product should be updated, without requiring further notification to the TGA or assessment.
  2. An IVD manufacturer makes a material change to a reagent (for example, changing a monoclonal antibody used in an ELISA kit, or the RNA primers included in a NAT assay) and the risk assessment shows that this could result in a change to the performance of the IVD outside the performance changes already approved by the TGA. This change has the potential to affect clinical decision making and this is a substantial change that requires notification to the TGA and assessment.
  3. A Manufacturer changes the design of an IVD for diagnosing HIV 1 to meet less stringent performance specifications. The change affects both sensitivity and specificity. Although the change does not alter how the IVD is used, or require labelling changes, it does alter performance compared to previously approved claims. Therefore, this is a substantial change that requires notification to the TGA and assessment.
  4. The manufacturer of an IVD updates their labelling by adding a new limitation after identifying a new medicine which could interfere with the result. The medicine does not affect the indications for use for the IVD nor significantly affect the risk profile. The manufacturer should document the change in the QMS; and the Technical file for the product should be updated.
  5. A change in the IFU for a Class 4 IVD, to include a new anticoagulant for plasma samples that are to be tested using the IVD, or any other new sample type not previously assessed, requires notification to the TGA and assessment.
  6. A manufacturer intends to add a production line for a new group of IVDs that use nucleic acid technology (NAT) to detect infectious disease markers, whereas previously they only produced immunoassay kits for detecting the same infectious markers. Even though the new NAT assays are the same 'kind of device' as the immunoassay kits that were previously assessed by the TGA, this is a substantial change to the manufacturing process and therefore requires notification to the TGA and assessment.
  7. A manufacturer has previously undergone assessment of three lots of stability data that were generated throughout a storage period of 13 months for a new IVD assay, and obtained approval from the TGA to supply their kits with a 12 month shelf life assigned. The stability studies of the kits were continued for a further 6 months and the manufacturer is satisfied that the kits continue to meet the assigned acceptance criteria, as outlined in the stability protocol. As the ongoing stability studies have reached completion, the manufacturer may assign a longer shelf life of 18 months without notifying the TGA or undergoing further assessment because the previously reviewed stability program has remained unchanged.

Appendix B: Examples of certificate transfers

Guidelines for notifying the TGA

29 June 2017

Examples below illustrate some events that would be considered to trigger the transfer of a conformity assessment certificate.

  • A manufacturer holds a TGA Conformity Assessment Certificate for the manufacture of several Class 4 IVD medical devices. The company also manufactures a range of lower class IVD medical devices. The manufacturer decides to separate the Class 4 IVDs from the rest of the business through sale of the lower class IVDs to another company. The Class 4 IVD manufacturer retains the same QMS but changes its name. In such a case, MD Regulation 4.8 would require the manufacturer to notify us about the change of name within 3 months.
  • A corporation has multiple divisions, some medical device and some pharmaceutical. Each division maintains its own QMS. The corporation decides to separate the pharmaceutical and medical device businesses into two separate entities. The pharmaceutical business is to retain the current business name and registration. The medical device businesses are to change name and register as new business entities. The medical device businesses hold TGA Conformity Assessment Certificates for the manufacture of the medical devices. The certificates are transferred to the new entity. In such a case, MD Regulation 4.7 would require the new business to apply to us for the name of the manufacturer to be changed on the conformity assessment certificate within 3 months.
  • A manufacturer holds a TGA Conformity Assessment Certificate and amalgamates with another corporation that manufactures medical devices that do not require a TGA Conformity Certificate for supply in Australia. The new entity (business) takes on a new name but retains all the current manufacturing sites of the two prior corporations. The TGA Conformity Assessment Certificate is transferred to the new entity, but the scope of the certificate does not increase to cover the devices at the second site. In such a case, MD Regulation 4.7 would require the new business to apply to us for the name of the manufacturer to be changed on the conformity assessment certificate within 3 months.
  • A manufacturer holds a TGA Conformity Assessment Certificate and declares bankruptcy. The Trustee in bankruptcy becomes the legal manufacturer of the medical devices. In such a case, MD Regulation 4.6 would require the trustee to inform us of the event within 3 months.

Version history

Guidelines for notifying the TGA

29 June 2017
Version Description of change Author Effective date
V1.0 Original publication Medical Devices Branch 29 June 2017