Medical Device Single Audit Program (MDSAP)

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Medical Device Single Audit Program (MDSAP)

In order to guarantee medical device safety, the International Medical Device Regulators Forum (IMDRF) realized how important it was to create a worldwide system for auditing and monitoring medical device manufacture. In 2012 a Medical Devices Single Audit Program was created with the goal of “jointly leveraging regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.
A medical device company that uses the MDSAP appoints a recognised Auditing Organisation (AO) to audit its QMS in accordance with the laws of the five participating nations: the US, Australia, Canada, Japan, and Brazil. The manufacturer’s quality management system is subject to a single annual assessment under the MDSAP, with a three-year certification cycle. As a result, the medical device manufacturer will be subject to a significant decrease in the frequency of audits and inspections by national regulators. The MDSAP results are applied in accordance with each nation’s legal framework. As of right now, only Canada has made the MDSAP mandatory for class II, III, and IV medical devices (MDs); it went into effect on January 1st, 2019. Every collaborating regulatory body has access to a database where the MDSAP audit results (audit report) are routinely uploaded.

International partners that are participating in the MDSAP include:

During the September meeting, the Saudi Food and Drug Authority (SFDA) of Saudi Arabia was welcomed as an official observer of the IMDRF by the IMDRF Management Committee. 

Benefits of MDSAP: A Single Audit by Auditing Organizations would:

  • Simplified Evaluations: Manufacturers can complete a single audit that satisfies the demands of several regulatory bodies thanks to MDSAP. This saves time and money by obviating the need for several audits by various regulatory agencies.
  • International Market Entry: Manufacturers can prove they are in conformity with all participating countries’ standards by taking part in the MDSAP. This may facilitate the opening up of new markets and lower trade barriers globally.
  • Constant Enhancement: Manufacturers can concentrate more on their core offerings, such R&D, product development, and customer support, by cutting down on the time and effort required to prepare for and go through several audits.
  • Hazard Assessment: A thorough evaluation of the manufacturer’s quality management system is offered by the MDSAP procedure. This can assist in the early detection of possible problems, lowering the chance of non-compliance and eventual recall or market withdrawal scenarios.
  • Minimized Regulatory Burden: A higher degree of quality management is encouraged throughout the company by the rigorous MDSAP audit, and this can result in better products, happier customers, and a more competitive edge.
  • Improved Standing: Manufacturers may more easily plan and efficiently manage their regulatory activities with the MDSAP’s clear and predictable regulatory path.

Risks: Risk of the MDSAP program could be:

  • Transparency
  • Follow-up Audits
  • Audit not passed – Sales stop in all five countries

Is MDSAP mandatory?

  • In Australia, Brazil, Japan, and the US, the MDSAP is optional. But from January 1st, 2019, it was required in Canada for class II, III, and IV medical equipment.
    Manufacturers who choose to take part in the MDSAP are required to include a list of the nations in which they already operate or plan to operate as distributors of their medical devices in their certification contract. The manufacturer’s QMS compliance is examined during the on-site audit in comparison to those nations’ national regulations.

    Procedure for the Medical Device Single Audit Program
     Like other management system audit programs, MDSAP is built on a three-year audit cycle that is carried out in compliance with ISO/IEC 17021 requirements:

    • First stage of the certification audit: paperwork review and general preparation assessment. usually involves going over the planned documentation.
    • Stage 2 of the first certification audit: Assess QMS adherence to ISO 13485 and other standards of regulatory bodies involved in MDSAP.
    • Annual surveillance audits are carried out to evaluate any modifications made to the manufacturer’s devices or QMS procedures since the first certification audit.
    • A recertification audit is carried out in the third year to assess if a manufacturer’s QMS is still appropriate and effective in fulfilling MDSAP requirements for QMS requirements.

What is the price of MDSAP certification?

The MDSAP procedures and the quantity of requirements unique to each country that must be evaluated during the audit are the main factors influencing the cost of certification. 

In what way do the provisions of ISO 13485 relate to the MDSAP audit criteria?

The requirements of participating regulatory agencies and the provisions of ISO 13485 are included in the MDSAP audit criteria. Additionally, devices, licenses, business registrations, adverse event reports, and other things may be subject to additional particular regulations from each regulatory body.

The ability of manufacturers to remove criteria from countries where they have no intention of marketing medical devices is a crucial feature for those putting the MDSAP into practice. This indicates that only the legal requirements that are relevant in the MDSAP nations where the company sells or plans to market its product are included in the MDSAP audit criteria, together with the norms of ISO 13485.

Conclusion

The Medical Device Single Audit Program (MDSAP) was created by the IMDRF in 2012 to streamline regulatory audits for medical device manufacturers. It allows a single audit to meet the regulatory requirements of multiple participating countries, including the US, Canada, Brazil, Japan, and Australia. MDSAP reduces the frequency of audits, saving time and costs while ensuring compliance with each nation’s laws. It is mandatory in Canada for Class II, III, and IV devices but optional elsewhere. By consolidating audits and maintaining high safety standards, MDSAP supports global market access and continuous quality improvement.

How Medfins can help –

A medical field expert helps manufacturers through the Medical Device Single Audit Program, or MDSAP, by covering regulation compliance, quality management systems, and audit readiness. Here’s how Medfins will help:

  1. Consultation and Gap Analysis: Medfins does a detailed gap analysis for the manufacturer’s QMS against the requirement of ISO 13485 and the country-specific regulations of MDSAP participating countries.
  2. Audit Preparedness: Medfins prepares and trains the manufacturer for the MDSAP audit by building documentation, processes, and internal audits for rectification of any flaws before the actual audit.
  3. Regulatory Awareness : Familiarity with the regulatory landscape in the US, Canada, Brazil, Japan, and Australia determines the capability of Medfins to enable manufacturers to identify and comply with requirements in every country.
  4. Maintenance Support: During the following annual surveillance audits, Medfins continues the support at the production site ensuring that the QMS is kept orderly and helping manage any changes to products or processes that impact that compliance.
  5. Risk Mitigation: Early identification of compliance risks allows manufacturers to avoid audit failures, product recalls, or market restrictions in MDSAP countries with Medfins’ support.

Simplifying this process for manufacturers, Medfins makes MDSAP smooth and more compliant with international regulatory standards through smooth audits.

Frequently Asked Questions (FAQs)

MDSAP certification is not related to CE marking certification. With its observer status, the European Union is not involved in the MDSAP’s implementation. On the other hand, both certification courses can be offered simultaneously.

MDSAP audits are conducted by recognized Auditing Organizations (AOs). These organizations are accredited and authorized by the participating regulatory bodies to conduct MDSAP audits. Examples of such organizations include BSI, TÜV SÜD, SGS, Intertek, and DEKRA.

An MDSAP audit is available to any medical device manufacturer planning to commercialize their product in one of the member nations. If appropriate, each regulatory authority may create exclusion standards for specific circumstances.

You can find recognized Auditing Organizations on the official websites of MDSAP regulatory members or by searching the MDSAP section of the IMDRF website. Alternatively, global certification bodies that comply with ISO/IEC 17021 are usually authorized to conduct MDSAP audits.

After an audit or re-audit is successfully completed, an auditing organisation will provide certification documentation with a link to the MDSAP certifying conformity with ISO 13485 and the relevant Medical Device Regulations from each jurisdiction that served as audit criteria.