What is The Medical Device Single Audit Program (MDSAP)?

The Medical Device Single Audit Program (MDSAP) provides medical device manufacturers with a single compliance certification based on essential standard and regulatory requirements for their quality management systems (QMS) in five major markets: Australia, Brazil, Canada, Japan and the United States.

National medical device regulators in each of these countries provide a clear definition for quality assurance and as a requirement for market access, manufacturers must submit to a QMS audit. This audit reviews the suitability of a company’s QMS, to ensure transparency and consistency of quality standards across an organisation, and the industry at large.

Recognising that the regulatory requirements across the five territories were similar, in 2014, the International Medical Device Regulators Forum (IMDRF) launched a pilot called MDSAP to explore whether a single audit could be recognised in all jurisdictions, ultimately helping to reduce the burden on both regulators and manufacturers. In 2017, that pilot was deemed a success and the IMDRF opted to make it permanent.

Why does it matter?

If you’re developing digital health technologies, there is a high chance that your solution could be (read SHOULD be) classified as a medical device. Confusingly, different jurisdictions can have very slightly different definitions of what constitutes a medical device, so it is important to check what those are when launching in new markets. 

Manufacturers of medical devices are subject to a number of regulatory obligations, which includes having an adequate quality management system (QMS) in place that meets national standards for medical device quality management. 

Sounds simple, right? It is. While standards across jurisdictions vary, MDSAP allows a manufacturer to undergo a single audit that assesses compliance against the national standards of each of the five jurisdictions. MDSAP, therefore, saves everyone precious time - manufacturers don’t need to submit for multiple appraisals - and simplifies the process all round - five markets, one audit. 

What is a QMS?

A QMS is a system of procedures and processes encompassing all aspects from design, manufacturing, supply, risk management, management responsibility, customer-related processes, and CAPAs (corrective and preventive actions). It exists to optimise the final solution and, most importantly, minimise any potential risk for the end-users.

How do I get a medical device audited under MDSAP?

MDSAP requires audits to be conducted by recognised ‘auditing organisations’ that have the appropriate accreditation. If an audit is not conducted by one of these approved organisations, then it goes without saying that that audit will not satisfy the requirements of regulators in any of the five jurisdictions.

If you’re commissioning an audit of your QMS, you can find a list of accredited auditing organisations on the US FDA website. 

Do I need MDSAP?

There are plenty of benefits to a MDSAP audit. 

If you have even the slightest of ambitions to launch in any of the five markets, the MDSAP route really is a no-brainer. 

The international standard for medical device QMS is ISO13485. However, each of the five jurisdictions has its own medical device QMS standards, most of which are stricter than ISO13485; even non-MDSAP members such as the European Union state their own regulatory requirements for the QMS of medical device ‘economic operators’ including manufacturers. Although preparation to meet MDSAP compliance criteria can be more challenging and the auditing process is longer, one single process is more time and cost efficient than five separate processes. MDSAP submissions are assessed against the compliance requirements of all five jurisdictions, and therefore, once approved, is deemed approved in those five countries too.

Wherever you are in your journey, even in the early stages of product development, MDSAP certification shows intent and confidence, sending a clear signal to investors that you are serious about taking your solution to market and scaling across multiple jurisdictions. 

How can Hardian Health help?

Getting healthtech to market doesn't have to be difficult. We are a team of multidisciplinary experts supporting innovators to accelerate healthtech to healthcare, safely, and securely. We are no strangers to developing a robust, compliant QMS for the clients we work with and we know that a QMS that isn’t developed around your specific business structure is more of a hindrance than a help. So we can work with you to find a compliant solution that meets the needs of your company, your customers and your regulators.

Hardian Health is clinical digital consultancy focussed on leveraging technology into healthcare markets through clinical strategy, scientific validation, regulation, health economics and intellectual property.