The Medical Device Single Audit Program (MDSAP) was developed in 2012 with the goal of creating a system where a single audit could be accepted across multiple jurisdictions. The program covers certification for ISO 13485 and also includes country-specific regulatory requirements, and provides many benefits to manufacturers including saving time and money. MDSAP is executed and utilized by a consortium of five regulatory bodies across five countries Australia (TGA), Brazil (ANVISA), Canada (Health Canada), U.S.A (FDA) and Japan (PMDA). If a manufacturer sells its device to all five participating countries, then the manufacturer must meet the QMS plus country-specific regulatory requirements of all five countries in order to be MDSAP certified.
Health Canada currently utilizes the CMDCAS (Canadian Medical Devices Conformity Assessment System) certificate per ISO 13485 as part of its medical device licensing process. MDSAP is not mandated by Australia, Japan, Brazil and the USA; however, as of January 1st 2019, Health Canada requires an MDSAP certificate from the manufacturer (or show proof that they are on track to be certified) to be able to market any medical devices in Canada and to maintain active device licenses.
Please review the following links and answer the questions below:
http://www.fda.gov/Training/CDRHLearn/ucm372921.htm
http://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/default.htm
https://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/ucm621589.htm
http://www.imdrf.org/documents/documents.asp
Discuss in your post all the following questions and include references.
1. Discuss and justify at least three pros and cons of the MDSAP program from the perspective of both the manufacturer and the involved regulatory bodies.
2. Do you think it is reasonable for Health Canada to mandate MDSAP requirement to market medical devices while it is not required in other markets – Justify why or why not.
3. What might be the potential consequences of the MDSAP mandate for both the Canadian healthcare industry and the Canadian citizens/healthcare consumers?
