Why is MDSAP Certification Needed?
To market Class II-IV medical devices in Canada, manufacturers must obtain a valid MDSAP certification, as required by Health Canada. This certification must be submitted as part of the application for a Medical Device Licence (MDL), together with additional documentation depending on the device class.
Aligning your QMS with MDSAP Health Canada requirements early in the process helps avoid delays in obtaining your Medical Device Licence.
What are the risks of skipping a proper MDSAP Gap Assessment
- Market access denial: Without MDSAP certification, Class II–IV devices cannot be sold in Canada.
- Audit non-conformities: Gaps in your QMS can lead to major findings, delays, and costly re-audits.
- Incomplete documentation: Incomplete or non-compliant documents may cause rejected submissions or long review times.
- Regulatory penalties: Non-compliance can result in penalties, product holds, or loss of licences.
How Obelis Supports Your MDSAP Readiness
Obelis will help your organization prepare for a successful MDSAP audit. We conduct a thorough review of your existing documentation and quality management processes, identify gaps against MDSAP requirements, and provide support through mock audits.
Our gap assessment covers key areas including your MDSAP audit checklist alignment and documentation structure, ensuring nothing is overlooked before your official audit.
This ensures your organization is well prepared to obtain MDSAP certification and access the Canadian market.
Frequently Asked Questions
The Medical Device Single Audit Program (MDSAP) is a program that allows a single QMS audit to satisfy the regulatory requirements of multiple countries simultaneously.
Participating regulatory authorities include Health Canada, the U.S. FDA, Brazil’s ANVISA, Australia’s TGA, and Japan’s MHLW.
The approach follows a structured sequence across seven processes: Management, Measurement, Design, Purchasing, Production, Servicing, and Device Marketing/Distribution. Auditors assess these in a specific order to evaluate systemic risk, meaning one finding can cascade into another process – making thorough preparation essential.
The MDSAP companion document is a technical reference published by the program’s participating authorities that maps MDSAP requirements to national regulatory requirements. It is an essential tool when preparing your QMS, as it clarifies exactly which clauses apply to which markets – including Canada’s specific expectations under Health Canada.
Key MDSAP documents typically include your quality manual, procedures covering all seven audit processes, records of management review, internal audits, CAPA, and complaint handling.
Timelines vary depending on the maturity of your existing QMS, but organizations typically need 6-18 months to prepare from scratch. A gap assessment conducted early in the process helps prioritize remediation efforts and can significantly reduce the time to certification.
Yes. While ISO 13485 forms the foundation of MDSAP, the program includes additional regulatory requirements beyond the standard – particularly those specific to Health Canada and other participating authorities.
A targeted gap assessment identifies where your existing system falls short of full MDSAP requirements, even if your ISO 13485 certification is current.
