Applying for AO recognition and Introduction of Prioritization Criteria
The process of assessing and recognizing a new MDSAP AO requires a significant commitment of MDSAP Regulatory Authority resources and the candidate AO. To maximize the benefits to the program that new AOs can bring and minimize the impact on resources, the MDSAP Regulatory Authority Council (RAC) has introduced measures to assist prioritize suitable AO applications to undergo assessment. These include mandatory criteria to initially screen applications to determine whether the candidate organization:
- is eligible for recognition as an MDSAP AO (see IMDRF/MDSAP WG/N3 FINAL: 2016 (Edition 2) Requirement for Medical Device Auditing Organizations for Regulatory Authority Recognition)
- can demonstrate financial sustainability (as reported in annual reports and financial statements)
- has access to sufficient auditors (and other technical personnel) to extend their service to clients seeking to be audited against the MDSAP.
Organizations assessed as having met mandatory requirements are then ranked against further criteria to prioritize applications for assessment. In selecting candidates, the MDSAP RAC may apply prioritization criteria that aligns with the strategic and operational requirements for the program. For the 2025 process, the prioritization criteria will include areas of expertise and geographic considerations. AOs must have demonstrated competence in each of the five MDSAP jurisdiction’s regulations.
While the MDSAP RAC has introduced criteria to prioritize applications, it can accept or reject an application, including if an applicant does not meet the minimum criteria. Further information on AO prioritization criteria can be found here.
2025 - MDSAP AO Application Pack
AO applications will open mid-2025 and candidates will have a 90-day period from the date of re-opening to submit their applications. When applications reopen, prospective AOs can apply for recognition by completing the candidate AO Application Package consisting of:
Copies of the application package are also available from the MDSAP RAC Secretariat.
All completed applications are to be submitted to the MDSAP RAC Secretariat for review of their completeness against a checklist. If an application is assessed as incomplete, the AO candidate will be notified. For further information on the procedure for review of a candidate AO’s application, click here.
AOs interested in applying for MDSAP recognition can contact the MDSAP RAC Secretariat if they have further questions about the application process.
Please note review and assessment of any application will not commence until after applications formally reopen.
Stage 1 – Documentation Review
After successful review of an AO’s application for recognition, a Stage 1 assessment will be scheduled in order of priority as approved by the RAC. The Stage 1 assessment involves a review and evaluation of the AO’s quality management system documentation against the assessment criteria. A Stage 1 assessment may occur on-site at the AO head-office, via teleconference, or through offsite document review. All findings will be discussed with the AO irrespective of the method of assessment used. A Stage 1 assessment report will be written by the assessment team identifying observations or issues requiring clarification. The outcomes of the report will used as an input into the Stage 2 assessment.
Stage 2 – Head Office Assessment
A Stage 2 assessment is used to evaluate the implementation, including effectiveness, of the AO’s quality management system, through the review of records, interviewing of staff, and review of other procedures not included in the Stage 1 review. An assessment plan is issued to the AO prior to the assessment. An assessment team performs the assessment, typically onsite at the AO’s head office location. The assessment commences with an opening meeting where the assessment team outlines the objectives for the assessment. The assessment team then performs the assessment in accordance with the assessment approach outlined in MDSAP AS P0034. This approach is broken down into specific assessment processes, including:
Management
Use of external resources
Management, analysis and improvement
Competence management
Audit and certification decisions process
Information management.
If any nonconformities are identified during the assessment, the assessment team documents these using the AO nonconformity report form and grades the nonconformity in accordance with IMDRF/MDSAP WG/N11 requirements.
The nonconformities are issued to the AO in the closing meeting. The AO is required to respond to the nonconformities in a timeframe dependent on the grading of the nonconformity. The assessment team writes and issues a report to the AO, detailing the assessment that has occurred.
Onsite assessment at critical locations
A critical location is a site, other than the head office, that performs one or more of the following critical functions:
Development and approval of the management system policies, processes and procedures for the audit and certification of medical device manufacturers within the framework of MDSAP.
Review and acceptance of applications and issuance of certification contracts, including the determination of scopes of certification and calculation of audit time.
Assignment of auditors, technical experts, and reviewers/certifiers to audits.
Technical review of audit reports and certification decision making activities.
Competence management activities as they apply to auditors, technical experts, reviewers, and certification officials.
Management, monitoring, and oversight by the AO of the medical device audit and certification programme.
Assessors will assess critical locations specifically for the activities they perform within the scope of the agreement between the AO head office and the location.
Witnessed audits
Witnessed audits allow qualified MDSAP RA assessors to verify that an AO effectively conducts their audits using the MDSAP Audit Approach and reports appropriately on the outcomes of audits. It is an essential assessment activity for building and maintaining confidence in the reliability of the third-party AO.
During a witnessed audit, the AO’s audit team conducts the audit of the medical device manufacturer and the RAs’ assessment team observes the AO without interfering in the audit process. The RA Assessment team does not assist or coach the AO auditors, nor does it provide additional information to the AO audit team or collect information on their behalf.
After the AO has issued the audit report, the RAs’ assessment team finalizes and shares their conclusions on the audit with the AO.
The RA conclusions are not in relation to the compliance of the manufacturer to ISO 13485 and the relevant regulatory requirements. The RA’s conclusions only relate to the ability of the AO to audit against the requirements of the MDSAP.
Ongoing surveillance
RA assessors will perform ongoing surveillance assessments of AOs throughout the recognition period. These assessments include, at a minimum, a reduced scope head office assessment and one witnessed audit per year.
Appealing a decision
If an AO disagrees with an unfavorable recognition decision or a nonconformity issued by the MDSAP RAs, it may formally file for an appeal to the MDSAP RAs. The process is defined in the Appeals Procedure.