Resources to become and remain competitive with MDSAP (Medical Device Single Audit Program)

 

  •  KNOW the new international regulations                               

 •  CONNECT with experts and leverage through networking

 •  EXPAND to maximize you reach to international market  

The MDSAP.ch website was born from the idea to create an exchange platform about all thematic linked to the new Medical Device Single Audit Program (MDSAP) and to help the Medtech companies in Switzerland to understand what is MDSAP and how this program will impact their businesses. As from the 01 of January 2017, MDSAP has become a fully lunched program and a quick responsiveness from the Medtech industry will be necessary in order to maintain market access in the countries participating in the program.

What Is MDSAP ?

The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations authorized by the participating Regulatory Authorities (RA) to audit under MDSAP requirements.

The MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.

The program’s main mission is to “…jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.”

Participating countries

The five participating countries have been running a three year MDSAP pilot. The pilot ended in December 2016 and the formal program with its implementation phase began in January 2017.

Health Canada has announced that as of 1 January 2019, they will terminate their current CMDCAS program and only accept MDSAP certificates.

 

Others Regulatory Authorities may eventually decide to participate in the MDSAP and to become active participants in the Program. For example, the World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Program and the European Union (EU) are Official Observer to the MDSAP Regulatory Authority Council (RAC) and Subject Matter Expert (SME) Work Group.