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MDSAP in Canada: Why It’s Vital for Your Medical Device’s Success

MDSAP Canada
MDSAP Canada

The Medical Device Single Audit Program (MDSAP) has revolutionized the landscape of medical device regulation in Canada, ensuring that devices used by Canadians meet the highest quality standards[1]. This program allows a single regulatory audit of a medical device manufacturer’s quality management system to satisfy the requirements of multiple regulatory jurisdictions, including Canada, the United States, Brazil, Japan, and Australia[2][3].

In this article, we will delve into the genesis and evolution of MDSAP, its impact on medical device manufacturers, and the benefits it brings to healthcare providers in Canada. We will also explore the operational aspects of MDSAP audits, the challenges and considerations for compliance, and the future of MDSAP in global medical device regulation.

The Genesis and Evolution of MDSAP

The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to improve international medical device safety and oversight[4]. This program allows a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of participating regulatory authorities, including the U.S. FDA, 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[4].

Key Milestones in MDSAP’s Development

Year

Milestone

2012

MDSAP initiated as a pre-pilot project

[6]

2014

MDSAP Pilot project announced

[6]

2015

First GMP certificate delivered by ANVISA using an MDSAP audit report

[6]

2016

Review of MDSAP Pilot project

[6]

2017

Program opened for applications from candidate Auditing Organizations

[3]

2019

MDSAP replaced CMDCAS in Canada

[6]

The U.S. Food and Drug Administration (FDA) faced challenges in inspecting every Class II and Class III medical device manufacturer every two years due to lack of funding[5]. In response, the FDA began a pilot program allowing a company to contract a third party for a quality system inspection, which would demonstrate the facility met regulatory requirements[5].

The MDSAP Regulatory Authority Council (RAC), composed of two senior managers from each participating Regulatory Authority, is the governing body of the MDSAP[3]. The MDSAP International Consortium Mission is to jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers on a global scale[3].

Benefits of MDSAP

  1. Enables appropriate regulatory oversight[3]
  2. Promotes more efficient and flexible use of regulatory resources[3]
  3. Promotes consistency and predictability of regulatory programs[3]
  4. Leverages existing requirements and procedures for conformity assessment[3]

Manufacturers from anywhere in the world can participate as long as a product falls under the jurisdiction of at least one participating Regulatory Authority and meets its quality management system requirements[7]. The program simplifies compliance with global quality management system (QMS) standards and reduces the industry’s resource burden[7].

MDSAP’s Impact on Medical Device Manufacturers

The Medical Device Single Audit Program (MDSAP) has significantly impacted medical device manufacturers by streamlining theregulatory compliance process across five participating countries: the United States, Canada, Brazil, Japan, and Australia[7]. This single audit program allows manufacturers to comply with the regulatory requirements of these countries through a single audit by a Notified Body, reducing time and costs associated with multiple audits[8].

Benefits of MDSAP for Manufacturers

  1. Efficientmarket access: MDSAP certification enables medical device manufacturers to access multiple geographies through a single, efficient audit process[8].
  2. Reduced frequency of audits: With MDSAP, each country interprets the results based on its laws, and audit results are stored in a shared database accessible to all member countries’ regulatory authorities, reducing the overall frequency of audits[7].
  3. Time and cost savings: A combined audit for ISO 13485, MDSAP, and CE marking results in reduced time and costs for manufacturers[8].
  4. Predictable auditing schedule: MDSAP offers a clear and prescriptive process with a predictable auditing schedule[7].
  5. Scaled audits for larger companies: The program provides scaled audits for larger companies, ensuring a comprehensive assessment of their quality management systems[7].

Challenges of MDSAP Compliance

Despite its benefits, complying with MDSAP can be complex and time-consuming for manufacturers due to several factors:

  1. Understanding and adhering to the regulations of multiple countries[7]
  2. Significant investment in time and resources for audits, documentation, and process improvements[7]
  3. Keeping up with changes in MDSAP regulations and guidelines, requiring ongoing monitoring and training[7]

MDSAP vs. Regular ISO 13485 Audits

MDSAP audits differ from regular ISO 13485 audits in several ways:

Aspect

MDSAP Audit

Regular ISO 13485 Audit

Scope

Covers regulatory requirements of five countries

Focuses on ISO 13485 standard

Recognition

Recognized by regulatory authorities in participating countries

Not necessarily recognized by regulatory authorities

Audit Frequency

Reduced frequency due to shared audit results

More frequent audits may be required

Grading System

Graded nonconformity findings

No graded findings

Manufacturers from anywhere in the world can participate in MDSAP as long as their product falls under the jurisdiction of at least one participating Regulatory Authority and meets its quality management system requirements[7]. By streamlining global auditing processes, MDSAP enhances safety and benefits manufacturers aiming to market their devices in its core countries and affiliates[7].

Operational Overview of MDSAP Audits

The Medical Device Single Audit Program (MDSAP) audits are conducted by authorized Auditing Organizations (AOs) that meet the MDSAP auditor requirements[7]. These audits follow a model and companion document that incorporate the regulatory requirements of the participating regulatory authorities[3]. The cost of conducting an MDSAP audit is determined by the commercial arrangement between the medical device manufacturer and the authorized MDSAP Auditing Organization[3].

MDSAP Audit Cycle and Scoring

MDSAP audits consist of the following stages over a three-year certification cycle[6][7]:

  1. Initial Certification Audit
  2. Two annual Surveillance Audits
  3. Recertification Audit

The audits are scored based on the GHTF SG3/N19:2012 Quality management system – Medical devices – Nonconformity Grading System for Regulatory Purposes and Information Exchange[6]. Nonconformities are graded using a 4-point matrix and then applying the initial point score to a series of escalation rules that may result in a higher final point grade[7]. A grade four or five non-conformance is considered very serious and requires a special process to quickly close the loop[9].

MDSAP Audit Scope and Duration

MDSAP audits have a wider scope compared to regular ISO 13485 audits, as they include regulatory compliance in addition to QMS compliance[10]. The audit reviews the entire QMS, device registration processes, and regulatory notification systems[10]. Topics covered during the audit may include the impact of regulatory strategy on product design, risk, outsourced activities, validation, and change management[10].

The duration of the MDSAP audit ranges from 15-44 minutes per task, depending on its complexity[11]. Two or three auditors may conduct the audit, and the length of the audit depends on the organization’s complexity and the number of applicable MDSAP tasks involved[10].

Preparing for an MDSAP Audit

To prepare for an MDSAP audit, companies should:

  1. Conduct internal MDSAP pre-assessments and MDSAP/ISO 13485:2016 mock audits[10]
  2. Have QA and RA personnel present during the audit[10]
  3. Double-check their approved suppliers list, including European Authorized Representatives, distributors, testing labs, and calibration labs[10]
  4. Consider engaging experienced MDSAP auditor consultants for outsourced audit support[10]

Regulatory Flexibility During COVID-19

During the COVID-19 pandemic, regulatory flexibility was applied to the medical devices manufacturing sector, allowing for remote MDSAP audits to maintain reliability and integrity[1].

By understanding the operational aspects of MDSAP audits, medical device manufacturers can better prepare for and navigate the audit process, ensuring compliance with the regulatory requirements of participating countries.

Benefits of MDSAP for Healthcare Providers in Canada

The Medical Device Single Audit Program (MDSAP) offers significant benefits to healthcare providers in Canada by ensuring access to high-quality medical devices and emerging technologies. MDSAP’s mandatory implementation in Canada for class II, III, and IV medical devices since January 1, 2019, has positively impacted the healthcare sector[7].

Improved Quality Standards and Patient Safety

MDSAP ensures that medical devices used in Canada meet higher quality standards, as all manufacturers holding medical device licenses in Canada now participate in the program[1]. This heightened level of quality assurance translates to improved patient safety and better outcomes for healthcare providers and their patients.

Access to Emerging Technologies

MDSAP enables healthcare providers in Canada to access emerging technologies more efficiently by:

  1. Facilitating first-in-man-use applications[12]
  2. Influencing the path of a technology to routine use[12]
  3. Helping in the technology evolution and learning curve[12]

This access to evolving technologies offers healthcare providers a route for technology introduction and evolution, ultimately benefiting patients who require innovative medical solutions[12].

Differences Between MDSAP and Regular ISO 13485 Audits

While MDSAP is mandatory in Canada, it is essential for healthcare providers to understand how MDSAP audits differ from regular ISO 13485 audits:

Aspect

MDSAP Audit

Regular ISO 13485 Audit

Scope

Covers regulatory requirements of participating countries

Focuses on ISO 13485 standard

Grading System

Graded nonconformity findings

No graded findings

Regulatory Recognition

Recognized by regulatory authorities in participating countries

Not necessarily recognized by regulatory authorities

These differences highlight the comprehensive nature of MDSAP audits, which ensure that medical devices meet not only the ISO 13485 standard but also the regulatory requirements of participating countries, providing an additional layer of assurance for healthcare providers in Canada[7].

Challenges and Considerations for Complying with MDSAP

Complying with the Medical Device Single Audit Program (MDSAP) presents several challenges and considerations for medical device manufacturers in Canada. The MDSAP puts a greater emphasis on risk management compared to ISO 13485:2016, requiring manufacturers to transform their quality management systems to consider risk management throughout all procedures and processes[9].

Understanding Product Classification and Audit Scope

One of the key challenges for manufacturers is to understand their product and its intended use, which is crucial under the MDSAP[9]. Manufacturers need to work closely with their Auditing Organization to ensure the scope of their audit is relevant to their product classification[9]. This ensures that the audit covers all necessary aspects of the quality management system and regulatory requirements.

Robust CAPA System

To maintain a compliant quality management system under MDSAP, manufacturers must have a robust Corrective and Preventive Action (CAPA) system in place[9]. This system should enable fast identification and containment of issues, ensuring that the manufacturer can quickly address any nonconformities identified during the audit process.

Differences Between MDSAP and ISO 13485 Audits

While MDSAP audits cover the requirements of ISO 13485, they go beyond the standard to include additional regulatory requirements specific to the participating countries. Some key differences include:

  1. Greater emphasis on risk management[9]
  2. Focus on product classification and intended use[9]
  3. Graded nonconformity findings[7]
  4. Regulatory recognition by participating authorities[7]

Preparing for MDSAP Audits

To successfully navigate the challenges of MDSAP compliance, manufacturers can seek support from specialized service providers, such as:

  • The FDA Group, which offers MDSAP auditing and support services, including preliminary audit services to assess and remediate systems against MDSAP requirements[7]
  • RQM+, which provides audit preparation, training, and mock audits for both MDSAP and ISO 13485[11]

By understanding the unique challenges and considerations associated with MDSAP compliance, and seeking appropriate support when needed, medical device manufacturers in Canada can ensure their quality management systems meet the necessary requirements, ultimately benefiting healthcare providers and patients through access to high-quality, safe, and effective medical devices.

The Future of MDSAP and Its Role in Global Medical Device Regulation

The Medical Device Single Audit Program (MDSAP) continues to play a crucial role in the global regulation of medical devices. The U.S. Food and Drug Administration (FDA) has demonstrated its commitment to the program by accepting MDSAP audit reports as a substitute for routine agency inspections[4]. This recognition of MDSAP audits streamlines the regulatory process for medical device manufacturers, reducing the burden of multiple inspections.

Alignment with ISO 13485:2016

The FDA has taken a significant step towards harmonizing its Quality System Regulation (QSR) with the international standard ISO 13485:2016. The agency issued a final rule amending the medical device Current Good Manufacturing Practice requirements to align with the ISO standard[13]. This alignment aims to:

  1. Enhance the quality and safety of medical devices[13]
  2. Reduce compliance burdens for device manufacturers[13]
  3. Integrate internationally recognized best practices into the U.S. regulatory framework[13]

However, the new standard and requirements under the final rule will not take effect until February 2, 2026[13]. This transition period allows manufacturers to assess and adapt their quality management systems to ensure compliance with the updated requirements[13].

Global Participation in MDSAP

MDSAP has garnered active participation from five countries: the United States, Canada, Brazil, Japan, and Australia[7]. This international collaboration promotes a harmonized approach to medical device regulation, benefiting both manufacturers and regulatory authorities.

Country

Regulatory Authority

United States

U.S. Food and Drug Administration (FDA)

Canada

Health Canada

Brazil

Agência Nacional de Vigilância Sanitária (ANVISA)

Japan

Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA)

Australia

Therapeutic Goods Administration (TGA)

As more countries recognize the value of MDSAP, the program’s influence on global medical device regulation is expected to grow. This expansion will further streamline the regulatory landscape, promoting consistency and efficiency in the industry.

The future of MDSAP looks promising, with its increasing acceptance and adoption by regulatory authorities worldwide. As the program evolves and aligns with international standards, it will continue to shape the global medical device regulatory framework, ensuring the safety, quality, and effectiveness of medical devices for patients around the world.

 

Need support with your MDSAP preparation?

FAQs

1. What are the advantages of participating in the MDSAP?
The Medical Device Single Audit Program (MDSAP) offers several benefits including minimizing disruptions from multiple regulatory audits, ensuring reliable audit schedules with defined opening and completion dates, improving patient health and access by facilitating entry into multiple markets, and optimizing the use of regulatory resources.

2. Is participation in the MDSAP a requirement for selling medical devices in Canada?
Yes, in Canada, it is mandatory to have your quality system certified as MDSAP-compliant by an Auditing Organization accredited by Health Canada and the MDSAP before you can market your medical device.

3. What are the primary goals of the MDSAP?
The main goal of the Medical Device Single Audit Program (MDSAP) is to allow a single regulatory audit of a medical device manufacturer’s quality management system that can meet the requirements of multiple regulatory jurisdictions.

4. What is the Special Access Program (SAP) for medical devices in Canada?
The Special Access Program (SAP) in Canada allows healthcare professionals to obtain medical devices that are not yet approved for sale in the country. This access is provided in emergency situations or when conventional treatments have failed, are unavailable, or are unsuitable for treating a patient.

References

[1] –https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/international/transition-medical-device-single-audit-program.html
[2] –https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/quality-systems-13485/requirements-recognition-process-mdsap-auditing-organizations-profile/guidance-document.html
[3] –https://www.fda.gov/media/90179/download
[4] –https://www.fda.gov/medical-devices/cdrh-international-affairs/medical-device-single-audit-program-mdsap
[5] –https://www.outsourcedpharma.com/doc/mdsap-history-and-advantages-0001
[6] –https://www.rimsys.io/blog/mdsap-the-ultimate-guide-to-the-medical-device-single-audit-program
[7] –https://www.thefdagroup.com/blog/mdsap-audits
[8] –https://prineos.com/en/blog/mdsap-and-its-benefits-a-single-audit-to-access-to-the-medical-device-market-of-the-5-member-countries-/
[9] –https://saiassurance.com.au/the-3-challenges-commonly-experienced-by-manufacturers-seeking-certification-to-the-mdsap/
[10] –https://www.orielstat.com/blog/mdsap-impacts-ra-and-qa/
[11] –https://www.rqmplus.com/blog/everything-you-need-to-know-about-the-medical-device-single-audit-program-mdsap
[12] –https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5863869/
[13] –https://www.ropesgray.com/en/insights/alerts/2024/02/top-10-takeaways-from-fdas-revised-quality-system-requirements-for-medical-devices

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