MDSAP: Raising the Bar for Medical Device Standards

Recognition of the need for a global program for medical devices has led to the development of the Medical Device Single Audit Programme (MDSAP). The MDSAP has been jointly developed by the national regulatory authorities of five countries to help ensure the safety and quality of medical devices, and raise standards around the globe.

The regulatory authorities involved are:

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

In addition, the World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) acted as official observers on the development of the audit.

MDSAP provides medical device manufacturers with a single quality management system audit that will satisfy the requirements of all participating regulatory authorities. The ultimate goal of the MDSAP is to create a coalition of countries that are dedicated to improving safety and oversight for medical device manufacturing.

Adoption of MDSAP among the five markets will create a more efficient auditing program, by minimizing regulatory overlaps. One objective is to create a less burdensome system of regulations for the sector without compromising public health. In addition, MDSAP seeks, where appropriate, to leverage the existing conformity assessment structures into one which is consistent, predictable and transparent, offering greater efficiency and sustainability in the oversight of medical device manufacturers.

Launched on January 1, 2014, the MDSAP underwent a three-year pilot program that ceased on December 31, 2016. The operational phase of the program then began on January 1, 2017, marking the start of the transition period.

Canada Adopts MDSAP

Health Canada had, however, already announced its intention to implement MDSAP as the sole mechanism for manufacturers to demonstrate compliance with the quality management system requirements of its Medical Devices Regulations, on December 4, 2015. The adoption of MDSAP will mean the replacement of the current Canadian Medical Devices Conformity Assessment System (CMDCAS) program, even for manufacturers who only intend to sell on the domestic Canadian market.

Transition from CMDCAS to MDSAP began on January 1, 2017, and will last for two years. During this period, Health Canada has announced it will accept both CMDCAS and MDSAP certification but, from January 1, 2019, all CMDCAS certificates will become invalid. After this date, medical device manufacturers must certify against MDSAP.

Benefits of MDSAP

By replacing multiple regulatory audits with a single medical device audit, MDSAP offers a number of advantages to participants. These include:

• Gaining access to multiple markets via a single audit
• Minimizing business disruption, while optimizing time and resources
• Assurance that products cover all the requirements of all five participating regulatory authorities
• The ease of having routine audits scheduled directly with the auditing organization

For participants of the MDSAP, it is also important to note that it offers complete coverage but does not add to the requirements of the relevant regulatory authorities, including all the conditions of the ISO 13485 - Medical devices: Quality management systems, requirements for regulatory purpose standard.

What now?

With the transition from CMDCAS to MDSAP already underway in Canada, manufacturers who already market medical devices in Canada, and/or Australia, Brazil, Japan, and the USA, should now assess their readiness for the introduction of MDSAP.

For further information, please contact:

Mirela Boureanu
Global Product Manager, MDSAP
t: +44 798 330 6970