The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published a user guide on the post-market review compliance dashboard. The document describes in detail how responsible parties can access, review and provide responses to requests from the regulating authority with regard to medical devices already placed on the market.

The latest version of a guide was published by the TGA in March 2021. The document is intended to assist medical device manufacturers and other parties involved in using the special system for post-market communications. The authority reserves the right to amend the guide, should it be reasonably necessary to reflect the changes in the system itself or in the applicable regulatory framework. The TGA also encourages the interested parties to provide their feedback and suggestions.

General Points 

The present document is dedicated to communication between the responsible party and the regulating authority by virtue of the Post Market Review (PMR) compliance dashboard. By using the dashboard, responsible parties can have access to requests or notifications submitted by the regulating authority and provide their responses, including the option to upload additional information and documentation. 

According to the guide, the requests covered by its scope include the following:

  • Requirement to provide information and documents,
  • Requirement to provide samples, and
  • Proposal to suspend or cancel entries from the Australian Register of Therapeutic Goods (ARTG). 

According to the guide, there are two role types available:

  • Drafter, who is allowed to review, upload documents and edit responses, and
  • Submitted, who is additionally allowed to submit responses. 

The designation of these roles is performed by the TGA Business Services (TBS) administrator. 

The Post Market Review compliance dashboard is accessible via the TGA Business Services website. A responsible entity can log in using its usual credentials. After successful login, a responsible entity will have access to all notifications received from the regulating authority. The system enables the sorting of these notifications using several criteria and filters to simplify the navigation. For each notification, it is possible to preview its content and create a draft response. Each notification will also have its reference number. 

Creating a Draft Response

The guide further describes how an interested party (a sponsor) can respond to notifications received from the TGA. For ease of reference, notifications could be linked to the appropriate entries in the Australian Register of Therapeutic Goods. However, should this information be insufficient, the authority may require a sponsor to provide additional information about the medical device in question. In such a case, a sponsor can add references to other entries in the register or provide additional details. This usually applies in the case of initial requests for information submitted by the authority. Since the account used to interact with the PMR compliance dashboard is the same one used for all submissions, all ARTG entries associated with the particular sponsor would be easily available for making references. The authority also mentions that each model of a medical device in question should be added separately for each ARTG entry. If the ARTG covers more than one model, all models should be indicated, even if some of them actually fall outside the scope of the current review. When providing information about each model of a medical device, a sponsor will also have to upload the Instructions For Use (IFU).

Additionally, a sponsor shall provide information about supply, complaints, and incidents associated with all models mentioned in the response. The particular period for which the data should be provided will be indicated in the initial request submitted by the authority. This information can also be provided for each year separately.

  1. With regard to supply details, a sponsor will have to provide information about the number of medical devices supplied in the country. Such information could be provided in various measurement units – boxes, packs, pieces, etc. – depending on the nature of the device and the way it is usually marketed. It is also necessary to provide similar information about medical devices supplied overseas for the same period.
  2. In terms of complaints, a sponsor shall tick the box whether any complaints have been received during the reporting year. If there were complaints, it would be necessary to indicate the number of both local (from Australia) and overseas (from abroad) complaints. In this section, a sponsor may also upload additional supporting documentation.
  3. In the section dedicated to incidents and adverse events, a sponsor will have to indicate whether any adverse events occurred during the reporting period. If there were any, a sponsor would have to provide information about the ones that occurred in Australia and abroad, the same as for complaints. Additionally, it will be necessary to indicate adverse event types and provide a breakdown of adverse events depending on types and categories.

For ease of use, the system allows sponsors to create ModelDetailsTemplates covering the points described above. In such a way, a sponsor can create a template that will be used for further submissions. The information can also be extracted in the form of a schedule (table). This applies to the information in numeric format (number of medical devices supplied in Australia, number of complaints, or adverse events divided by region). The same table could also be used for providing the appropriate information. In such a case, a sponsor will have to fill in all necessary fields and upload the table to the system.

Providing Evidence of Compliance 

The present guide also clarifies the way sponsors shall provide evidence of compliance with the applicable regulatory requirement. In particular, sponsors should have to provide additional information and upload documentation in order to demonstrate compliance with the regulations indicated in the initial notification from the authority. 

When editing the section, a sponsor may:

  • Provide a summary,
  • Attach evidence of compliance,
  • Both. 

If options number 2 or 3 are selected, the system will not allow the submission of a response without attaching a file. 

Responding to Additional Information Request and Submitting Information 

In certain cases, the authority may require a sponsor to provide additional information on another specific matter. The approach to be applied should be the same as for providing evidence of compliance. 

If a sponsor finds that the information requested by the authority cannot be provided within a timeframe indicated in the appropriate notice, it is allowed to file a request for an extension. However, the authority mentions that in certain cases, an extension could not be provided. 

In summary, the present TGA guide provides detailed instructions regarding the way the Post Market Review compliance dashboard should be used by sponsors when providing responses to requests from the regulating authority. The document describes the main procedures step-by-step and provides additional clarifications in order to assist sponsors in using the system. 

Sources:

https://www.tga.gov.au/resource/post-market-review-compliance-dashboard 

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