Medical Device Single Audit Program (MDSAP)

Multiple countries are participating in the program including the USA, Australia, Brazil, Canada, and Japan. One item of note is that manufacturers selling products in the Canadian market were initially required to transition by 2019. The pilot phase for the program originally began in January 2014 and concluded in December 2016. Based on the evaluation of the data collected during the pilot, the MDSAP Regulatory Authority Council deemed that the Pilot had demonstrated viability.

For more information about Health Canada’s transition requirements click here and for more information from the FDA about industry feedback and updates click here.

Regulatory Compliance Associates can assist with the continuum of quality assurance services required including QMS implementation, registration, and life cycle management of your medical device products. Whether you are preparing for an MDSAP Audit or you just need to understand the impact, RCA can assist. We offer support in the following areas:

• Gap Assessments to assess compliance to ISO 13485:2016 and MDSAP requirements
• Assistance with implementing recommendations as identified during the gap assessment
• Assistance with the transition to ISO 13485:2016 and MDSAP
• Assistance with understanding what needs to be updated or revised to get certified by a recognized MDSAP Auditing Organization
• Assistance with preparing for the rigors of an MDSAP audit by performing a mock audit/inspection