Information for Medical Device Suppliers
Recalls and Corrective Actions
Safety related actions taken by manufacturers and suppliers to address issues affected products in the market are called recalls and corrective actions. These should be conducted in consultation with Medsafe according to the Medsafe Uniform Recall Procedure for Medicines and Medical Devices.
Glossary of Corrective Action Terms
Preparation for a Corrective Action
Advising Medsafe
Drafting a Corrective Action Notice
Conducting the Corrective Action
Reporting to Medsafe
Closure of the Corrective Action
Download the Uniform Recall Procedure (Adobe PDF document 416 KB)
Glossary of Corrective Action Terms
Understand the language of recalls and corrective actions. The glossary provides definitions for the key words used when describing or conducting corrective actions.
Link to Glossary of Corrective Action Terms
Preparation for a Corrective Action
Sponsors should have a plan or procedure describing how to respond to a corrective action should the need arise. This planning should include where to obtain additional information, who is responsible for the action, and when to communicate with Medsafe.
Information about preparing for a corrective action
Advising Medsafe
Recalls and corrective actions should be conducted in consultation with Medsafe. To assist with this process the sponsor should be able to provide Medsafe with information about the nature of the problem, the product(s) involved, details of the distribution of the affected product(s), and the action planned.
Information about advising Medsafe about a corrective action
Drafting a Corrective Action Notice
Corrective actions are communicated to the affected customers via corrective action notices. These notices should be reviewed by Medsafe prior to being distributed to customers/users for appropriateness and to ensure compliance with the Uniform Recall Procedure. Draft templates for key types of corrective actions are available for download.
Information about drafting a corrective action notice
Conducting the Corrective Action
Once Medsafe and the sponsor are agreed on the action to be taken the sponsor will be required to advise the affected customers and conduct the corrective action. Medsafe may offer guidance on how customers should be advised and the action be conducted.
Information about conducting the corrective action
Reporting to Medsafe
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.
Information about providing progress reports to Medsafe
Closure of the Corrective Action
When the agreed action has been completed the sponsor should submit a final report on the action to close the investigation. The final report will also include details of the disposal or export of any affected product.
Information about providing a final report to Medsafe
Page last updated 10 May 2011