Medical Device Single Audit Program (MD-SAP)
The MDSAP Pilot was intended to allow MDSAP recognized Auditing Organizations to conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of the medical device regulatory authorities participating in the pilot program.
International partners that participated in the MDSAP Pilot included:
- Therapeutic Goods Administration of Australia
- Brazil’s Agência Nacional de Vigilância Sanitária
- Health Canada
- Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
- The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) are Official Observers
Following successful completion of the pilot Health Canada has been the first of the international partners to announce that they will be fully adopting the scheme.
As of January 1st 2019, Health Canada will only accept MD-SAP style audits to show compliance with Canadian regulations and conformity with the requirements if ISO 13485.
An interesting feature of these audits is the grading assigned to non-conformities which follows the GHTF guidelines (SG3/N19:2012).
Direct Impact
When the nonconformity has the potential to affect safety or performance, it should be written against the specific requirement in ISO 13485 found in clauses 6.4 through 8.5, because it has direct QMS impact.
Indirect Impact
When the nonconformity is against the manufacturer’s quality manual, procedures or requirements, is not specifically required in ISO 13485 or does not impact safety or performance, then the nonconformity should be assigned to clauses 4.1 through 6.3, because it has indirect QMS impact.
If the nonconformity that has previously been identified in either of the two previous QMS audits (against the same sub-clause (X.X.X))
The nonconformity poses an increased risk because it is an indicator that a corrective action has not been adequately taken or implemented
Scoring and Escalation
The score can be further escalated by the two following scenarios;
- The absence of a documented procedure or process (the score is escalated by 1)
- The release of a non-conforming medical device as a result of the non-conformity (the score is escalated by 1)
Contact should be made as soon as possible with your certification body to ensure that you have planned arrangements for the assessment based on MDSAP criteria to take place if you sell medical devices into the Canadian market.
