What is MDSAP?
The Medical Device Single Audit Program (MDSAP) is a harmonized approach to auditing and monitoring the quality management systems of medical device manufacturers on an international scale. It was developed by a group of medical device regulators (the IMDRF) to recognize third-party auditors to conduct a single audit of a medical device manufacturer that will cover ISO 13485:2016 and their respective regulatory requirements.
This allows a single audit of a medical device manufacturer's QMS which satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations (AO), authorized by the participating Regulatory Authorities (RA) to audit under MDSAP requirements. Accordingly, Medical Device Single Audit Program audit reports may be used by regulatory authorities in lieu of their own inspection reports. The current program participants include: USA, Canada, Australia, Japan and Brazil.
MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.
MDSAP certification Audit
Audits are conducted annually, according to a three-year certification cycle, by approved auditing organizations (notified bodies). Audit time is based on tasks, not employee count, with an average of 15 minutes per task. All MDSAP audit reports must be submitted to all regulators. As part of the program, regardless of the outcome, all regulators will be reviewing the reports. Additionally, a database will be set up for these reports, so any of the participating countries can review reports associated with a particular organization or medical device, as well as trending nonconformities.
Nonconformities are graded on a scale of one to five, with a grade of 1, 2, or 3 considered a minor nonconformity, and grades of 4 or 5 considered more serious. If an audit identifies one or more grade-5 nonconformities, more than two grade-4 nonconformities, a public health threat, or any fraudulent activity, the auditing organization must inform regulatory authorities within five days. An unannounced follow-up visit six to nine months later will verify that appropriate corrective actions have been effectively implemented, and subsequent follow-up visits are then scheduled.
In most cases, the manufacturer must provide a remediation plan for each non-conformance within 15 calendar days of the date the nonconformity report was issued. In cases involving grade 4 or grade 5 nonconformities, final response — with evidence of effective corrective action — must be provided within 30 days of the last day of the audit.
Auditing organizations are expected to provide an audit package, which includes non-conformance grading, to regulatory authorities within 45 days of the end of the audit.
What are the benefits of MDSAP certification?
- Reduces the number of audits and inspections a manufacturer must undergo.
- Efficient, single audit scheme minimizes business disruptions, reduces costs and saves time.
- Expedites entrance into some markets where traditional regulatory oversight can cause significant delays.
- Consistency of multiple, international regulatory programs by participating regulators.
The MDSAP program was officially implemented in January 2017, following the completion of the pilot program.ã€€
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.
Maven understands the specific challenges medical device manufacturers face and the importance of bringing innovative yet safe products to global markets. Ensuring the predictability and transparency of regulatory clearance is key to maintaining a competitive edge.
Partner with us and gain the confidence of knowing you have a solid quality management system in place for medical devices. We can be your one-stop solution.