The objective of the MDSAP is to develop, manage, and oversee a single audit program that will allow a single regulatory audit of a Medical Device manufacturer, conducted by an MDSAP recognised auditing organisation, to satisfy the needs of multiple regulatory jurisdictions.
The participating regulatory authorities hope to achieve more consistency among the auditing organisations.
By following the MDSAP Audit Model:
- Audits performed for MDSAP will be conducted in a consistent manner across auditing organisations.
- Audits will be conducted logically and efficiently, with attention to the interactions between processes.
- Auditors will be able to determine whether systemic quality management system nonconformities are present.
The MDSAP program was officially implemented in January 2017, following the completion of the pilot program.
Health Canada requires all license holders to change from CMDCAS to MDSAP by December 31, 2018.
Health Canada will terminate the CMDCAS program on December 31, 2018. After this date, Health Canada will only accept MDSAP certificates from manufacturers with their device applications or renewals. To facilitate uninterrupted market access, TÜV SÜD will no longer be conducting CMDCAS audits as of September 30, 2017.
- Any manufacturer may participate if a product falls under the scope of at least one participating Regulatory Authority and will be subject to their quality management system requirements.
- Manufacturers located anywhere in the world are eligible to participate.
- Only the MDSAP participating countries will have direct access to the audit reports.
- Manufacturer's cannot select which of the 5 regulatory schemes are to be included within the audit scope. All country specific requirements of the manufacturer's target sale countries must be included.
(This applies to the current 5 participating countries only - Australia, Brazil, Canada, US, Japan)
Achieve access to multiple markets with a single audit through the MDSAP. If you are interested in the program, please contact Georg Bauer in Europe or Dawn Tibodeau in the US.
Note: Regulators will be witnessing some audits. This will be for the evaluation of the Auditing Organization, not the manufacturer.