MDSAP

Introduction

In an increasingly globalised medical device market, regulatory compliance has never been more complex or critical. With device manufacturers eyeing multiple jurisdictions, each with its own regulatory framework, staying compliant while scaling becomes a significant hurdle. The Medical Device Single Audit Program (MDSAP) is a global solution to streamline quality management system audits for medical device manufacturers.

Launched as a pilot in 2014 and fully operational since 2017, MDSAP offers a single audit that satisfies the regulatory requirements of multiple participating countries. For manufacturers seeking operational efficiency and market access, MDSAP can be a strategic advantage.

In this article, we’ll explore what MDSAP is, its benefits, participating countries, structure, challenges, and why it matters for medical device companies aiming to go global.

What is MDSAP?

The Medical Device Single Audit Program (MDSAP) allows an MDSAP-recognised auditing organisation to conduct a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory authorities.

Developed by the International Medical Device Regulators Forum (IMDRF), MDSAP aimed to reduce duplication of regulatory audits and improve oversight of medical device manufacturing on a global scale.

Currently, the MDSAP audit process satisfies the quality management system (QMS) requirements for the following five participating countries: Here is the list formatted in Markdown with full regulator names and hyperlinks to their main websites:

• United States – Food and Drug Administration (FDA)
• Canada – Health Canada
• Brazil – Agência Nacional de Vigilância Sanitária (ANVISA)
• Australia – Therapeutic Goods Administration (TGA)
• Japan – Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA)

Other jurisdictions, such as the European Union (EU), do not officially participate in MDSAP but may still accept MDSAP reports as part of their broader due diligence or market entry processes. The EU is an Official Observer of MDSAP, enabling it to monitor the programme and its outcomes.

Why was MDSAP created?

The goals behind MDSAP are straightforward:

• Harmonise regulatory practices across multiple countries.
• Reduce audit fatigue for manufacturers who previously needed to undergo multiple country-specific inspections.
• Optimise resource allocation by regulators through third-party audits.
• Promote early detection of compliance issues and reduce the burden on post-market surveillance.

For regulatory authorities, MDSAP enables more efficient use of their own resources while still maintaining oversight. It offers manufacturers a standardised approach to demonstrating compliance across multiple jurisdictions.

How does MDSAP operate?

Auditing Organisations (AOs)

MDSAP audits are conducted by Authorised Auditing Organisations accredited by the participating regulatory authorities. These can be notified bodies or third-party certification bodies with proven competence in medical device auditing.

Audit Model and Duration

MDSAP audits are based on a process-based audit model aligned with ISO 13485:2016. The audit includes the following key processes:

• Management
• Device marketing authorisation and facility registration
• Measurement, analysis, and improvement
• Design and development
• Production and service controls
• Purchasing

Audit duration is determined by the number of sites, employees, risk class of devices, and jurisdictions where the manufacturer is seeking market access.

Nonconformity Grading System

MDSAP uses a grading system to evaluate the severity of nonconformities, taking into account both the clause violated and the impact on the safety and performance of the device. Grades range from 1 to 5, with higher grades requiring more urgent and comprehensive corrective actions.

Country-specific applications of MDSAP

Although MDSAP aims for harmonisation, each participating country applies the programme slightly differently.

MDSAP vs. ISO 13485: What’s the difference?

Many medical device companies already comply with ISO 13485:2016, the international standard for QMS in the sector. While MDSAP audits are built on the ISO 13485 foundation, there are important distinctions:

In essence, MDSAP is ISO 13485-plus—with enhanced regulatory alignment and country-specific requirements embedded into the audit.

Considerations for manufacturers

• Market Access Efficiency: MDSAP provides a streamlined path to multiple key markets via a single audit, reducing duplication and compliance overhead. With one quality system meeting multiple jurisdictions’ expectations, companies can unify their internal procedures and minimise variability. However, the programme currently covers only five countries. For access to the European Union, China, India, and other major markets, additional compliance steps are still necessary. Further, as there are country-specific add-ons, even with MDSAP certification, some countries (like Brazil or Japan) require supplementary documentation or language translations.
• Audit Procedures: A single audit event minimises time away from core operations compared to staggered country-specific audits throughout the year. Unlike unannounced audits under EU MDR, MDSAP follows a planned schedule, allowing better resource management and internal preparation. However, because MDSAP audits are comprehensive, they tend to be longer and more rigorous than a standard ISO 13485 audit. Initial MDSAP audits can also be more expensive, especially for small and medium-sized enterprises (SMEs). However, many manufacturers find that reduced audit duplication and faster market access offset the costs.
• Regulatory Confidence: Having MDSAP certification boosts regulatory confidence in your quality system. It shows proactive compliance and risk management.

Is MDSAP right for you?

Ideal Candidates for MDSAP:

• Companies seeking access to multiple participating markets
• Manufacturers with an existing ISO 13485 certification
• Firms looking to streamline internal processes and reduce audit fatigue
• Organisations preparing for due diligence or acquisition, where international compliance is scrutinised

MDSAP is less ideal if:

• The primary market is the EU, China or other LMIC markets, where MDSAP is not yet formally recognised
• The manufacturer is a small or medium-sized business with limited exports to MDSAP-participating countries. However, even smaller manufacturers may find value in MDSAP if they’re planning to scale internationally.

Looking ahead: The future of MDSAP

The success of MDSAP has raised questions about whether the model could be expanded. Some key future developments include:

• Additional country participation, including potential expansion to other IMDRF members.
• Greater alignment with EU MDR/IVDR, especially as pressure mounts for global harmonisation.
• Integration of remote audits, especially post-COVID-19, which accelerated digital regulatory practices.

Ultimately, MDSAP represents an important step in reducing fragmentation in global device regulation—an essential move in a world of increasingly complex medical technologies and supply chains.

While it may not fit every company, MDSAP can be a catalyst for broader success for those navigating international growth. Whether you’re a startup seeking first-market entry or a multinational aiming to consolidate your compliance footprint, understanding and leveraging MDSAP could be your next competitive edge.

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