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 pilot program is now underway. Achieve access to multiple markets with a single audit by participating in the MDSAP pilot program. If you are interested in participating in the pilot program, please contact Gary Minks.
MDSAP Pilot program:
July 2014 to December 2016
This implementation will begin at the conclusion of the Pilot on January 1, 2017, and will span a period of two years. During this two year period, Health Canada will accept certificates issued under both CMDCAS and MDSAP. As of January 1, 2019, only MDSAP certificates will be accepted.
For more information about the transition plan, click here.
- 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 by participating in the MDSAP pilot program. If you are interested in participating in the pilot program, please contact Gary Minks.
Note: Regulators will be witnessing some audits. This will be for the evaluation of the Auditing Organisation, not the manufacturer.