MDSAP programs
Response 1
MDSAP programs have distinct advantages that are imperative to both manufacturers and regulatory bodies. The programs aid in reducing the expenses of both manufacturers and regulators, as they sometimes these bodies lack the resources to carry out complete audits[1].
However, in as much as MDSAP programs have notable advantages, they also have some elements that make them unsuitable in some situations[2]. For instance, the whole process of MDSAP is challenging to undertake and requires enormous resources, which most manufacturers do not have. Besides, new policies touching on MDSAP are challenging to implement, therefore, giving institutions globally difficulties in making adjustments[3]. The cumbersome process mentioned of transitioning requires a realignment of laws in some countries leading to setbacks in implementation[4].
Institutions in Canada have a mandate to set up MDSAP programs as they aid in increasing efficiency[5]. Canada should not copy what other countries do and put in place an environment that permits MDSAP processes.
MDSAP program
Response 2
An MDSAP program in place has many advantages. For instance, it prevents fraud anywhere in the world as it cuts across many countries. Besides, auditors work seamlessly with little or no interruption, as they need not refresh their knowledge periodically, as was the case in the past whenever they carry out their auditing process. However, the program also has some disadvantages in that it does not include Europe due to the existing EU regulations in place and the need for a complete change of systems during adjustment to MDSAP programs.
When looking at the pros of an MDSAP system and weighing these against the cons, the advantages make a sound argument and confirm that MDSAP procedures are imperative in efficient audit systems anywhere in the world. Also, a developed country like Canada with efficient auditing procedures previously in placed adopted MDSAP systems confirming that the practice has many benefits to any other country that embraces it[6].
Bibliography
Bills Edwin (Aug 2019), MDSAP — History, and Advantages, Retrieved from https://www.meddeviceonline.com/doc/mdsap-history-and-advantages-0001
Johner Institute, MDSAP: Medical Device Single Audit Program, Retrieved from https://www.johner-institute.com/articles/qm-system-iso-13485/mdsap/
Sam Rajkumar. Week 5 Slides. “Overview of International Regulatory Compliance.” Accessed 30 Jan 2020.
Seouser. “Moving to a Single-Audit System: MDSAP Requirements for Medical Device Manufacturers.” isoTracker, October 18, 2019. https://www.isotracker.com/blog/moving-to-a-single-audit-system-mdsap-requirements-for-medical-device-manufacturers/.
Shawn M. Schmitt (Feb 2019), Canada’s Switch From CMDCAS To MDSAP Went Off Without A Hitch – Despite 403 Firms Leaving The Market, https://medtech.pharmaintelligence.informa.com/MT124581/Canadas-Switch-From-CMDCAS-To-MDSAP-Went-Off-Without-A-Hitch–Despite-403-Firms-Leaving-The-Market
Tüv , (Feb 2017), Ensure Transparency And Compliance In Advertising With Tüv Süd Certification Marks https://www.tuvsud.com/en/e-ssentials-newsletter/healthcare-and-medical-devices-essentials/e-ssentials-1-2017/canada–smooth-transition-from-cmdcas-to-mdsap
[1] Bills Edwin, MDSAP — History, and Advantages (Meddeviceonline, Aug 2019)
[2] Johner Institute, MDSAP: Medical Device Single Audit Program (Johner institute)
[3] Sam Rajkuma, Overview of International Regulatory Compliance (week 5 slides, 2020)
[4] Tüv , Ensure Transparency And Compliance In Advertising With Tüv Süd Certification Marks ( Tuvsud, 2017)
[5] Seouser. “Moving to a Single-Audit System: MDSAP Requirements for Medical Device Manufacturers (Isotracker, 2019)
[6] Shawn M. Schmitt (Feb 2019)Canada’s Switch From CMDCAS To MDSAP Went Off Without A Hitch – Despite 403 Firms Leaving The Market (pharmaintelligence, 2019)