Introduction to the Medical Device Single Audit Program (MDSAP)
The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF identified a workgroup to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP).
What is MDSAP?
The Medical Device Single Audit Program (MDSAP) is a program that conducts a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions.
Why was the MDSAP developed?
The MDSAP was developed to enable appropriate regulatory oversight of medical device manufacturers’ quality management systems. The idea is to promote more efficient and flexible use of regulatory resources through work-sharing and mutual acceptance among regulators while respecting the sovereignty of each authority. Also, in the longer term, promote greater alignment of regulatory approaches and technical requirements based on international standards and best practices
Which Regulatory Authorities are part of the MDSAP?
The MDSAP was developed by representatives of the Australian Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, MHLW/PMDA, and the U.S. Food and Drug Administration (FDA). All regulatory authorities participating in the MDSAP are equal partners in the program.
Which manufacturers are eligible for an MDSAP audit?
Any manufacturer of medical devices is eligible. However, each regulatory authority may establish exclusion criteria for some manufacturers. It is important to note that manufacturers that participate in the MDSAP program are responsible for securing and maintaining a contract with an MDSAP recognized auditing organization. In other words, medical device manufacturers are responsible for paying for MDSAP audits conducted by an auditing organization.
Does the MDSAP add requirements for the manufacturer?
No. The MDSAP audit model was developed to cover existing requirements from the Regulatory Authorities participating in the MDSAP. The program does not add any new requirements to existing requirements from ISO 13485.
What are the potential benefits?
- The MDSAP reduces the overall number of audits or inspections and optimizes the time and resources expended on audit activities.
- Reduce FDA routine inspections and minimize manufacturing plant and personnel disruptions.
- Minimize medical device manufacturer disruptions due to multiple regulatory audits.
- Provide predictable audit schedules (agendas with opening and completion dates).
- Consistent auditing from a single source for multiple regulatory requirements.
- As a longer-term goal, it is expected that the program will enhance confidence in the reliability of third-party audits.
- Some participating regulatory authorities will use MDSAP audit outcomes as an alternative to their own inspections to process applications for medical device marketing authorization.
- MDSAP may be seen as evidence of a medical device manufacturer’s commitment to quality management systems for product quality and regulatory compliance.
What are the costs associated with MDSAP audits
The cost of conducting an MDSAP audit is dictated by the commercial arrangement between the medical device manufacturer and the authorized MDSAP auditing organization.
COVID-19 Remote Audits
The spread of Covid-19 globally has resulted in the imposition of quarantine orders and travel restrictions that are affecting the ability of auditing organizations to perform MDSAP audits.
On-site audits can only be substituted with remote audits where travel restrictions or social/physical distancing as a result of the pandemic prevent on-site audits from occurring.
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For more detailed information about MDSAP please take a look at their documentation.
- MDSAP Assessment Procedures and Forms
- International Medical Device Regulators Forum
- MDSAP audits during COVID-19
- Auditing Organization Availability to Conduct MDSAP Audits
- MDSAP Regulatory Authority Contact Information