In June 2014, Health Canada provided clarification and instruction to Certification Bodies on the manufacturers recall process during CMDCAS audits.
As a result, CMDCAS auditors have been instructed to verify specific requirements and guidance related to recall processes at forthcoming ISO 13485:2003 CMDCAS audits.
Why do you need a recall process?
The HPFB Inspectorate reported that not all manufacturers certified under CMDCAS fully comply with the recall requirements of the CMDR (Canadian Medical Devices Regulation) and that procedures are often inadequate or too generic.
To ensure patient safety and public health is maintained, it is imperative that regulators are made aware of recalled marked devices in a timely manner so that they can contain or mitigate risks.
Health Canada therefore expects any ISO 13485:2003 certified manufacturer will have established documents procedures for the use and implementation of advisory notices and that these procedures will meet or exceed what is required in sections 52 to 56, 58 (b), and 63 to 65.1 of the Regulations.
How does this impact your organisation?
LRQA has put together a client information note (CIN) on the recall process for ISO 13485:2003 under the CMDCAS program to help organisations to comply with the requirements of the Regulations and prepare for future visits.
Download your Recall Process CIN for:
- An explanation into the recall process
- The requirements to be audited and verified
- An overview of what LRQA will be looking at during the visit
Need to know more?
For help and advice, please call +44 24 7688 2393 or email email@example.com