Stop worrying about enforcing a safety culture! A safety culture can be built by constantly making people aware of reporting regulations and requirements based on the countries in which you are selling your medical devices. 

If your medical device is currently sold in Australia the prompt Incident Reporting of Medical Devices by the Australian TGA would certainly be of interest to you.

Australian TGA released a guidance document for the manufacturers to easily report medical device incidents. For smooth reporting of incidents, the MDIR system has been updated for Manufacturers and now the Manufacturers will be able to  perform the following:

  1. Submit reports online
  2. Provide more information on already reported occurrences
  3. Check on the status of reports
  4. View and update the initial and follow-up reports 

Additionally, with this new system, the TGA receives all the submitted reports and updates immediately.

The TGA Business Services (TBS) website provides access to a number of systems, including MDIR. To visit the TBS website, you must first have a valid account that can be accessed using unique access credentials. This ensures that the information transferred is secure. The MDIR system can be accessed directly either via the MDIR login web page or via the TBS portal. The TGA emphasizes the importance of updating passwords on a regular basis, as it expires after 90 days.

Looking for How to Report?

Here is an easy manual!!

Step 1: Log in to the TBS Portal. 

Step 2: Click on the ‘New Report’ button at the top right of your screen to submit a new medical device incident report.

Step 3: Make sure the fields marked as mandatory are filled, otherwise the reports would not be processed. 

Step 4: Save a draft report if any of the information necessary is not available to you at the time of submission. 

The primary details you will have to enter are shown in the image below:

  • Report Details: Give indications about the Report Type.
  • Reporter Details: Specify information about the reporter, including the details about the responsible person submitting the report and his/her contact details, as well as the information about the company in general, including its location.
  • Healthcare Facility Details: This information is not mandatory but will help TGA to identify potential duplicate reports submitted and assist in trend analysis of health care facilities.
  • Device Identification: This information will be auto-generated by the TGA based on the details available in the TGA registry and the device ARTG number or other details such as brand/trade name, model/serial/batch/lot numbers, date of the device in case of implants. Upon submission, the information in this section would be available only to the Sponsor, associated with this ARTG entry.
  • Clinical Event Information: Here in the ‘Description of Event or Problem’ field, you can give a description that is solely related to the root cause of the clinical event and should neither describe the patient/healthcare facility nor the results of an investigation carried out by the manufacturer. In the respective fields following, you can mention such information regarding the patient, their clinical care, and about other devices involved in the event, irrespective of the sponsorship. Further, you can provide the results of the manufacturer’s investigation and information regarding the corrective and preventive actions (CAPA). Also in the next field provide information about similar events that occurred for three years before the incident in question.
  • Report Attachments: Here you can substantiate the incident if you deem to, by providing images and documents of size less than 16 MB.
  • Submission: You shall submit the report. Following this Device Incident Report (DIR) number will be issued along with confirmation. 

Also, details shall be updated and reports can be submitted as a follow-up by 120 TGA days of initial reporting. After the closure, you can still update information by reaching out to iris@health.gov.au, along with your DIR number.  

After the Medical Device Incident Reports are submitted, you can track the reports through the portal of submission like the TBS site.

Puzzled by various standards, regulatory requirements, and updates relevant to your medical device? 

You are not alone! Elexes is helping many companies across the world to overcome these hurdles to place their medical devices in the market successfully and help maintain compliance at the post-market stage. Please reach out to jennifer@elexes.comfor more information and we will be happy to assist you!

#elexes #healthcare #australia #tga #regulatory #mdr #medicaldevice #clinical #product

Elexes Team

Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.

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