MDSAP 101: An Introduction to the Medical Device Single Audit Programme

What if you could gain approval to sell your medical devices anywhere in the world, by completing a single, regulatory audit process? That may be the ultimate dream of the Medical Device Single Audit Program (MDSAP). But how quickly is it being realised, and what’s really involved for medical device developers to reap its benefits?

What is the MDSAP programme? 

Initiated as a pilot programme in 2014 by the International Medical Device Regulators Forum (IMDRF), the MDSAP is a way that medical device manufacturers can be audited once for compliance with the standards and regulatory requirements of multiple medical device markets.

In other words, instead of juggling multiple inspections and documents with different regions’ regulators, you can satisfy their requirements in one streamlined audit sequence, making the approval process much more cost-effective, efficient and predictable.

Why the MDSAP programme is important

As global health challenges rise, governments across the world want medical device and pharma companies to be able to share their innovations across borders more rapidly.

As the Covid pandemic proved, international cooperation between regulators and developers can bring enormous public health benefits. It can help increase the availability and affordability of medical devices. It can help life-saving medical technology be iterated more rapidly and successfully, while all the time retaining a firm grip on patient safety.

The MDSAP is already making this kind of cross-border growth more possible for more medical device developers, which is why politicians are embracing its ambitions:

"The MDSAP is a significant undertaking that will bring together regulatory authorities from around the world to harmonise their medical device inspection processes. This will save time and money for medical device manufacturers, and it will ultimately lead to safer and more effective medical devices for patients."   

U.S. Congressman Michael Burgess, M.D.

Which countries are currently participating in the MDSAP programme?

The countries whose regulatory authorities are currently signed up to the MDSAP programme include:

• United States (FDA)
• Canada (Health Canada)
• Japan (MHLW/PMDA)
• Brazil (ANVISA)
• Australia (TGA)

How does the MDSAP programme work?

This audit assesses compliance with the ISO 13485 standard and specific regulatory requirements of each participating country.

The MDSAP audit framework is structured around seven critical process elements:

• Management
• Device Marketing Authorisation and Facility Registration
• Measurement, Analysis, and Improvement
• Reporting of Medical Device Adverse Events and Advisory Notices
• Design and Development
• Production and Service Controls
• Purchasing

Each section has specific questions that must be answered during the audit. This helps manufacturers prepare in advance because they know exactly what auditors expect to see.

How is the MDSAP audit process broken down?

The audit is a three-phase audit process designed to ensure medical device manufacturers meet stringent quality standards.

The process begins with an Initial Audit, divided into two stages: Stage 1 focuses on reviewing the Quality Management System (QMS) procedures and documentation for preparedness, while Stage 2 examines records of actual compliance.

Following this, the Surveillance Audit, conducted over two years, assesses the ongoing effectiveness of the QMS, particularly any changes since the initial certification.

The final phase, the re-certification Audit, is a year-long comprehensive review of the entire QMS, ensuring sustained compliance.

This structured approach ensures that manufacturers not only meet the MDSAP requirements initially but also maintain these standards over time.

Who conducts the MDSAP audits?

Audits under the MDSAP are conducted by specific Auditing Organisations (AOs). Manufacturers engage these AOs to carry out their MDSAP audits just as they work with Notified Bodies to gain ISO 13485. Many of these AOs, like the BSI, are also equipped to perform audits in accordance with ISO 13485 at the same time.

What are the main benefits of the MDSAP?

MDSAP and the harmonisation of standard promises to bring a new emphasis on quality and efficiency to the global medical device market, through:

• Faster compliance - streamlining compliance processes will help relieve large parts of the administrative burden from innovating companies.
• More accessible, affordable technology - in the long term a more streamlined approach will make more products available to more people, faster.
• Safer more effective products - harmonisation of standards should lead to the adoption of regulatory best practice from around the world - enhancing patient safety and increasing standards.

What are the challenges in MDSAP adoption?

Many companies have noted the cost of participation in the scheme - which may put it out of reach for some smaller companies.

It should be noted the acceptance and application of MDSAP certification can still vary across different countries, with some like Canada making it mandatory, while others use it simply to streamline or complement existing regulatory processes. We are not quite yet at the point of a true single audit process for every participating country.

Also, no one really know how long will it take for other significant countries to join the MDSAP programme. Regulatory control is jealously guarded by many nations (just think about the UKCA saga), for whom it’s an important symbol of independence and the protection of their own quality requirements. It may take a while for some companies to ‘give up’ their auditing sovereignty to a single body.

That said, Japan and the USA, the two largest medical device markets in the world are participating, which should be incentive enough to take its potential seriously.

Conclusion

Despite its currently modest participation levels, the program holds significant potential for the industry, offering the long term promise of reduced compliance costs for device manufacturers. By eliminating the necessity for multiple quality system audits and inspections, a successful implementation of the program could bring substantial benefits to those who can dedicate the resource to participate.

Companies who have a firm grip on their process, and have already gained ISO 13485 using a flexible eQMS, may find it a relatively easy process to marshal their documentation to meet the auditing demands of the MDSAP programme.

If they can, they may reap extraordinary rewards as the programme develops its reach around the world.