The Medical Device Single Audit Programme (MDSAP) is a system by which the participant competent authorities to recognise the quality management certification (as awarded after audit against both ISO 13485 and county specific requirements) from a single authority for medical device and in-vitro diagnostic medical device (IVDs) legal manufacturers.
The programme has been established by the International Medical Device Regulators Forum (IMDRF) and is intended to provide a harmonised approach to demonstrating the compliance of the Quality Management System (QMS) using a globally recognised approach.
The MDSAP was developed by the IMDRF to:
- Enable appropriate regulatory oversight of medical device manufacturers’ quality management systems while minimizing regulatory burden on industry;
- Promote more efficient and flexible use of regulatory resources through work sharing and mutual acceptance among regulators while respecting the sovereignty of each authority;
- Promote globally, in the longer term, a greater alignment of regulatory approaches and technical requirements based on international standards and best practices;
- Promote consistency, predictability and transparency of regulatory programs by standardizing;
1. the practices and procedures of participating regulators for the oversight of third party auditing organizations, and
2. the practices and procedures of participating third party auditing organizations
Regulatory Authorities
MDSAP consists of Regulatory Authority Council Members, Observers and Affiliate members:
Regulatory Authority Council Members:
- 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
- U.S. Food and Drug Administration
The RAC is the decision-making body of MDSAP and consists of representatives from all regulatory authorities that are members of the RAC. The RAC provides direction, oversight, and resources to support the MDSAP development, implementation, maintenance, and expansion.
Observer Members:
- European Union (EU)
- Singapore’s Health Sciences Authority (HSA) (NEW)
- United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA)
- The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme
The observers do not observe RAC members and do not attend RAC meetings, but they do observe and contribute the RAC activities. Both the EU and UK have been Observers for over 2 years, and as such, can apply to become full RAC members if desired.
Affiliate Members:
- Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT)
- Ministry of Health of Israel
- Kenya’s Pharmacy and Poisons Board (New member)
- Republic of Korea’s Ministry of Food and Drug Safety
- Federal Commission for Protection from Sanitary Risks (COFEPRIS) of Mexico
- TFDA – Taiwan Food and Drug Administration
Affiliate members are not members of the RAC or an Official Observer, but engages in MDSAP, demonstrates understanding of MDSAP and utilizes MDSAP audit reports and MDSAP certificates for evaluating compliance with applicable medical device requirements, including a manufacturer’s quality management system, under the Affiliate Member’s regulatory framework.
The application of the MDSAP Programme
The utilisation of the MDSAP programme, and the resulting certificates are utilised differently depending on each Competent Authority as dedicated by each regional requirement.
| Regulatory Authority | Utilisation of MDSAP |
| Australia | MDSAP audit report is used as part of the evidence that it has assessed for compliance with medical device market authorization requirements, unless excluded or exempt from these requirements. |
| Brazil | ANVISA utilizes the outcomes of the program as part of the pre-market and post market assessment. |
| Canada | Manufacturers intending to place a product on the market in Canada must have an MDSAP Certification issued by an Auditing Organization. |
| Japan | The Ministry of Health, Labour and Welfare (MHLW) and Pharmaceutical and Medical Devices Agency (PMDA) utilize these audit reports in pre-market and post-market audits. |
| United States | U.S. FDA will accept the MDSAP audit reports as a substitute for FDA routine inspections under a 510(k) device application. The use of MDSAP is not utilised for pre-approval or post-approval inspections for Pre-Market Approval (PMA) applications. |
The regulations for the above Regulatory Authorities are available (English) from the USA FDA Website.
The use of the MDSAP programme and certification will be greater utilised as he programme expands and more regulatory authorities recognise the value in this process.
The MDSAP Audit Cycle and Auditing Organisations
Auditing Organisation are certification bodies that have successfully applied, and been recognised by the MDSAP programme to audit medical device manufacturers against the requirements of the MDSAP programme. The current list includes many European Notified Bodies (under EU IVDR), and UK Approved Bodies (under UKCA) and are globally recognised.
The MDSAP audit is typically build on to the existing ISO 13485 certification audit of the Quality Management System with a 3-year audit cycle.
Figure 1 MDSAP Certification Cycle
Will MDSAP come to the EU and UK?
There is much talk regarding the use of MDSAP by the EU and UK. While I am a strong advocate in global harmonisation, the existing members joined MDSAP to find a harmonised way to create a robust process for standardising QMS requirements from a position where they needed to find a suitable and robust process. Regardless of the state of play in the EU and UK, both regions already have robust mechanisms for the surveillance of ISO 13485, largely provided by the technical and commercial expertise of EU and UK Notified Bodies and Approved Bodies (as part of ISO13485 certification/IVDR conformity assessment), so the utilising MDSAP would be less impactful.
The opportunity would be regarding the outward facing regulatory convergence of EU and UK to align, and reduce burden for accessing other markets, MDSAP would be a good way of doing this. We have seen TGA become well placed in MDSAP/IMDRF mainly utilising CE marking for supporting AUS market access.
The challenge with MDSAP is that each jurisdiction has specific requirements, which make the MDSAP process clunky. The key to an improved model is to remove local requirements as much as possible, however this is dependent on global alignment at a political as well as regulatory level.
References
- MDSAP P0003: MDSAP Roles and Responsibilities | FDA
- Q and A (fda.gov)
- The Medical Device Single Audit Program (bsigroup.com)
If you’d like to discuss MDSAP with us, you can book a call with the IVDeology team as we navigate this new programme and what it means for you as a manufacturer or provider of IVD’s and devices with each of the individual requirements. Being part of BIVDA (British In Vitro Diagnostics association), we’re in a great position to be able to receive and understand information and distribute to our networks as it comes, in a reliable and digestible way.
Or if you’d like support in other areas of Quality assurance or regulatory compliance, we’d be happy to chat with you. We can support with Quality management system implementation, transfer or uplifting.
We’ll be keeping you up to date with MDSAP news on our LinkedIn page and website, so do follow up on our socials and keep up to date with IVDeology along with Abingdon Health PLC.
Written by Stuart Angell, MD and Co-founder of IVDeology and IVDeology UKRP
