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Simplifying Certification: the Medical Device Single Audit Program

MDSAP-intland-blog-postAs the regulatory burden on developers of medical technology increases, any support they get in simplifying inspection and certification processes is highly appreciated. That’s the primary aim of the Medical Device Single Audit Program (MDSAP).

What is the Medical Device Single Audit Program?

In essence, MDSAP simplifies the oversight of medical device manufacturers and at the same time reduces the regulatory burden on the industry.

MDSAP is a program that allows medical device manufacturers to leverage existing regulatory resources, and helps consolidate the global regulatory assessment process. With the help of Auditing Organizations, they can conduct a single regulatory audit of their QMS systems to achieve compliance in several global markets.

Related reading: FDA's Digital Health Precertification Program

The program is expected to improve the safety and oversight of medical technology on an international (and even global) scale. In the long run, MDSAP aims to promote “consistency, predictability, and transparency of regulatory programs” by aligning the requirements of regulatory bodies globally.

Due to the multiple regulatory jurisdictions covered by MDSAP, medtech developers can assert compliance with regulatory requirements of the following medical device markets: Australia, Brazil, Canada, Japan and the United States. Audits are conducted by Auditing Organizations authorized by participating regulatory authorities.

How does MDSAP work?

Assessment in the MDSAP program is conducted in 4-year cycles. After the initial authorization has been acquired via the first certification audit, two yearly follow-ups ensure continued adherence to requirements. In the fourth year, a recertification audit is carried out, and a new cycle begins.

It’s important to note that MDSAP is not a standalone regulation per se: it does not add any further requirements for developers of medical devices – other than the existing requirements of ISO 13485 or other specific requirements of the regulatory authorities participating in the program. If you currently comply with relevant regulations in these countries, MDSAP doesn’t require any extra effort, but greatly streamlines your audit process.

Related reading: Medical Devices Quality Management Systems and Changes in ISO 13485:2016

The program was designed to cover the requirements of the following regulations:

  • ISO 13485 – Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:)
  • and any corresponding section(s) of the Australian Therapeutic Goods (Medical Devices) Regulations (SR 236, 2002)
  • Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013)
  • Canadian Medical Device Regulations (CMDR, Part 1)
  • Japanese QMS ordinance (MHLW MO 169)
  • US Quality System Regulation (21CFR 820)
  • and other country-specific requirements.

When conducting an inspection, Auditing Organizations will follow a procedure outlined in MDSAP AU P0002. Any nonconformities discovered will be graded on a 1-5 scale, and will be managed based on the QMS described in MDSAP program materials. Any action plans resulting from this inspection (related to nonconformities) will have to be implemented by the developer of the medical device in a timely manner. Upon successfully completing the inspection, Auditing Organizations will provide a report on audit outcomes, and certification documents to prove compliance with the regulatory requirements covered by the program.

Further information is available on FDA’s page dedicated to MDSAP Policies, Procedures, Templates and Forms.

Benefits of MDSAP

By participating in MDSAP, medical device developers can cut the total number of inspections they have to go through in order to have their products certified. This means a reduction in the time and other resources required by compliance.

In the long run, organizers of the program expect further Regulatory Authorities to join the program, or to accept audit data resulting from MDSAP programs to accelerate or reduce the number of their inspections. The program explicitly encourages Regulatory Authorities to use the output of MDSAP audits as input for their medical device marketing authorization processes – in time, MDSAP may replace proprietary inspection processes.

Another great boon for medical device developers is that through the use of a standardized MDSAP audit model, the program could help improve the predictability of inspections and their outcomes. A standardized grading system for nonconformities, and a uniform report template help both medtech developers and auditors.

Under the jurisdictions of the different authorities participating in the program, there might be further benefits for medical device developers in each geographical area covered. The specific market authorization processes of these regulatory bodies may be shortened or even waived as a result of successful MDSAP audits.

Watch our on-demand webinar: Intland Software’s Roundtable Discussion: Agile in Medical Technology

While MDSAP is a great way for medtech manufacturers to accelerate the certification and audit process, it doesn’t provide support in the actual implementation of mature development procedures. Intland Software’s codeBeamer ALM is a great tool used by global medtech innovators worldwide to simplify the development process itself. Using Intland’s Medical IEC 62304 & ISO 14971 Template, you can significantly cut the time and costs of compliance by implementing a robust QMS and an effective system of continuous compliance.

Want to learn more?

Customer Case Study: Medtronic Download PDF