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?

There are other ways to study the history of communication aside from interviewing people.  Please take the same topic that you conducted your interview on for Exam Question #2 and use a different method to learn and report more about it.  If you did not complete Exam Question #2, please take a look at that exam question’s description and choose one of the events on the list. 

Topic: First time they saw Color TV

Guidelines:

            Make sure that your response is one page (APA style) or less.  Points will be deducted if your response is longer than one page.  Please provide a succinct but thorough response.  Learning to write within a word limit is a valuable skill.

            Be sure to include references in APA format.  References do not count against your word limit.  References should be on a separate page. Please also include a title/cover page.

General Grading Criteria

The following is a general guideline regarding the 5 different categories on the rubrics.  Please see comments in Carmen for more details when you get your grade back, but this is a general note:

Exceptional responses briefly but succinctly combine information from lecture and outside sources (we will talk about using the library).  The response is extremely well written and organized in APA format.  There is little to no room for improvement. Exceptional responses demonstrate that you can reiterate information from the lecture and other course materials, find and integrate additional relevant information on your own from sources outside of the course materials, and incorporate your own original analysis.
Above Average responses briefly but succinctly answer the questions, combining information from the class as well as information from outside class.  There is some additional information that may improve the response but overall it is above average.
Average responses meet the minimum requirements of the assignment.  However, information needs to be clarified or there is information that is incorrect.  Improvements could be made in organizing information from different sources.
Needs Improvement means there was some key information missing or inaccurate/irrelevant information included.
Not Addressed generally means that the information was missing or inaccurate.