Information for Medical Device Suppliers
Progress Reporting on Corrective Actions
While the corrective action is in progress Medsafe requests that sponsors provide regular progress reports. These reports should detail how the action is progressing and provide information about the manufacturer's investigation and response to the issue leading to the action.
Frequency of Progress Reporting
Medsafe requests that an initial progress report is submitted two (2) weeks after the corrective action notice was distributed. Further progress reports are requested at monthly intervals after the initial progress report.
Medsafe should also be immediately advised of any developments that impact on the conduct of the corrective action. For example, a delay in the expected delivery of replacement goods or upgrades, changes by the manufacturer to deployment plans, and technical difficulties.
Content of Progress Reports
Progress reports should include a minimum of the following information;
- The date that the corrective action notice was distributed
- A list of the affected customers and the date that each acknowledged receipt of the notice
- Action being taken by the sponsor to follow up with affected customers that have yet to respond to the notice
- If it is a product recall, details of the quantity of affected product returned by each customer
- If it is a product correction, details of the date and quantity of upgrades/modifications completed by each customer
- An estimated date of completion for the action
- Details of the root cause of the issue that led to the corrective action
- Details of the manufacturer's corrective and preventative action (CAPA) to prevent a recurrence of the problem
- Information about any difficulties experienced during the conduct of the corrective action
Download a Progress Report Template
Medsafe has prepared a suggested corrective action progress report template that sponsors may download and use when submitting progress reports. Use of the progress report template is optional. Sponsors with their own reporting templates may continue to use their own forms.
Download the corrective action progress report template (Microsoft Word Document 52 KB)
Page last updated 10 May 2011