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SGS: MDSAP - Raising the Bar for Medical Device Standards

With Health Canada transitioning from CMDCAS to MDSAP, manufacturers must now consider the effects of the introduction of this global program for medical device production.

Geneva, Switzerland, January 07, 2018 --( Recognition of the need for a global program for medical devices has led to the development of the Medical Device Single Audit Programme (MDSAP). The MDSAP has been jointly developed by the national regulatory authorities of five countries to help ensure the safety and quality of medical devices, and raise standards around the globe.

The regulatory authorities involved are:

-Therapeutic Goods Administration of Australia (TGA)
-Brazilian Agência Nacional de Vigilância Sanitária (ANVISA)
-Health Canada
-United States Food and Drug Administration (US FDA)
-Japan’s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and -Medical Devices Agency (PMDA)

In addition, the World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) acted as official observers on the development of the audit.

Launched on January 1, 2014, the MDSAP underwent a three-year pilot program that ceased on December 31, 2016. The operational phase of the program then began on January 1, 2017, marking the start of the transition period.

Transition from CMDCAS to MDSAP began on January 1, 2017, and will last for two years. During this period, Health Canada has announced it will accept both CMDCAS and MDSAP certification but, from January 1, 2019, all CMDCAS certificates will become invalid. After this date, medical device manufacturers must certify against MDSAP.

By replacing multiple regulatory audits with a single medical device audit, MDSAP offers a number of advantages to participants. These include:

Gaining access to multiple markets via a single audit
Minimizing business disruption, while optimizing time and resources
Assurance that products cover all the requirements of all five participating regulatory authorities
The ease of having routine audits scheduled directly with the auditing organization
What now?

With the transition from CMDCAS to MDSAP already underway in Canada, manufacturers who already market medical devices in Canada, and/or Australia, Brazil, Japan, and the USA, should now assess their readiness for the introduction of MDSAP.

Read the full article here:

For further information, please contact:
Mirela Boureanu
Global Product Manager, MDSAP
t: +44 798 330 6970

About SGS
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 90,000 employees, SGS operates a network of over 2,000 offices and laboratories around the world.
Contact Information
Anna Amato
201 508 3029

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