What is MDSAP?

MDSAP stands for Medical Device Single Audit Program. It was a program that was created as an alternative to FDA auditing in conjunction with international regulators. With MDSAP, there is an opportunity to participate in international auditing for five different countries. The countries include Australia, Canada, Brazil, the US, and Japan. As it relates to the current COVID-19 crisis, the MDSAP can allow you to navigate your operation between regions and prepare your recovery to a full operation based on the recovery of countries you have participated in.

The MDSAP helps to fulfill the role of providing a single regulatory audit for all medical device manufacturers’ quality management systems. Also, the MDSAP meets all the laws and regulations required in several international jurisdictions. With the MDSAP companies can develop acceptable audits by FDA standard and reduce the number of auditory inspections and expedite the recovery of your manufacturing in the sequence of the recovery of your MDSAP covered regions.

It is crucial to note that only recognized organizations can conduct the MDSAP. Likewise, manufacturing companies can choose to voluntarily join the MDSAP pilot program. The program aims to be recognized internationally for participating countries. The pilot program kicked-off in 2014 and concluded in 2016. More detail about the MDSAP pilot program will be highlighted in this series.

International Regulators: IMDRF

It is no secret that international regulators have been seeking a standardized global approach to the monitoring and auditing of medical device manufacturing companies. In the last ten years, the community of international regulations has taken significant steps to build a sustainable framework. Leveraging works from previous organizations like the Global Harmonization Task Force, the International Medical Device Regulators Forum (IMDRF) have spearheaded the efforts in the creation of this framework. As a result, they were able to develop explicit criteria for MDSAP.

Who is Responsible for the Creation of MDSAP and MDSAP Pilot Program?

The people/parties responsible for the creation of MDSAP and MDSAP pilot include;

  • The IMDRF Management Committee (MC) regulators consist of representatives from China, Brazil, EU, Australia, Russian, Canada, Japan, and the US.
  • Observers from the Asia Pacific Economic Commission Life Science Innovation Forum (APACLSIF) and the World Health Organization (WHO).
  • Affiliate Organizations like the Pan-American Health Organization and the Asian Harmonization Working Party.
  • Working Groups like the IMDRF that produce standards, MDSAP, Submissions, UDI, MCAR software.


International Medical Device Regulation Forum

MDSAP is the fruit of over 10 years of planning by International regulators responsible for the IMDRF. The IMDRF is a group of voluntary medical device regulators from various parts of the world. They often gather to discuss the future and plans for medical device regulatory convergence and harmonization.

The IMDRF also discuss the following subjects when they convene;

  • The acceleration of international medical device regulatory harmonization and convergence.
  • The requirements and documentation needed for both MDSAP and MDSAP Pilot.


History of IMDRF

In February 2011, the International Medical Device Regulation Forum (IMDRF) was born. Similar to other international regulatory groups, IMDRF recognizes the impact of having a global approach for auditing and overseeing medical device manufacturers.  With a global approach, they could enhance both oversight and safety on an international scale.

The first meeting of the IMDRF took place in Singapore in 2012. During the meeting, the group selected a workgroup with the sole purpose of developing documents for a single audit of the program. The single audit program is the MDSAP and as a result, they launched the MDSAP pilot study.


IMDRF and MDSAP Requirements/Documentation

The IMDRF workgroup made sure that MDSAP had documents that cover the following;

  • Initial recognition surveillance and recognition criteria for MDSAP-Recognized Organizations (AO).
  • Standardized Recognized Audit Organizations, auditor competency, and competency maintenance requirements.
  • Standardized regulatory authority assessor competency and competency maintenance requirements.
  • Standardized audit and assessment models
  • Auditing of a manufacturer by an MDSAP-Recognized AO.
  • Assessment of MDSAP Recognized AO’s by participating Regulatory Authorities.


The purpose of the MDSAP Pilot

The purpose of the MDSAP Pilot is as follows;

  • To pilot the implementation of the requirements that are defined in the IMDRF MDSAP model.
  • Enable appropriate regulatory oversight of the medical device manufacturer’s quality management system while minimizing the regulatory burden on the industry.
  • 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.
  • To globally promote greater alignment of regulatory approaches and technical requirements based on international standards and long-standing practices.
  • To promote consistency, predictability, and transparency of regulatory programs by standardizing the practices and procedures of participating regulators with the oversight of third-party auditing organizations.
  • To standardize the practices and procedures of participating third-party auditing organizations.
  • To leverage where appropriate, the existing requirements and procedures for conformity assessment.


The MDSAP Pilot Timeline

Between the periods of January 1st, 2014 to December 31st, 2016, the FDA and other participating international regulators were part of the Medical Device Single-Audit Program Pilot. A report detailing the outcome of various perspectives, criteria, and proof-of-concept, to establish the viability of the MDSAP Pilot Program. The report was released on June 29th, 2017. The outlined outcomes were based on the foundational data gathered during the three-year pilot phase.

The final outcomes are as follows;

  • Both the International MDSAP governing body and the MDSAP Regulatory Authority Council agree that the MDSAP Pilot sufficiently demonstrates its viability for the Medical Device Single Audit Program.
  • A fully operational MDSAP was to be in effect in 2017 following a successful conclusion to the pilot at the end of 2016.
  • Canada decided to accept MDSAP rather than CDMAS in January of 2019.


The MDSAP Timeline

In 2012, the IMDRF launched the Medical Device Quality Audit Program. The goal of this initiative to pool resources together and ensure the safety of medical devices sold to the customers. The IMDRF put up a working group to cater to the details of the program. The MDSAP program has its foundations in various international standards and procedures. Some of which include;

  • ISO 13485: 2003 now become 2016
  • The Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013)
  • The US Quality System Regulation (21 CFR Part 820)
  • Other specific pre and post-market regulatory requirements if the authorities of various participating members of the group.

Based on these foundations Orcanos creates a state of the art eQMS platform that handles all product lifecycle stages in one single system. Just as the single auditing system impacts the acceleration of innovation, the Orcanos single processing system is able to integrate natively with the Design Control, Quality, Regulation, and Manufacturing.

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