The decision, which took effect on December 12, 2017, was made by the MDSAP Technical Review and Recommendation Committee and endorsed by the MDSAP Regulatory Authority Council.
When asked how this will impact SGS, Mirela Boureanu, Global Product Manager of MDSAP, stated: “This is a great achievement for SGS, as we are one of only a few certification bodies to be granted this. We will now be able to provide our clients with an increased level of service and expertise, ultimately proving we aim to be the most competitive and the most productive service organization in the world."
MDSAP allows recognized Auditing Organizations to conduct a single audit of a medical device manufacturer, which will be accepted by all five regulatory authorities participating in the program:
- Therapeutic Goods Administration of Australia (TGA)
- Brazilian Agência Nacional de Vigilância Sanitária (ANVISA)
- Health Canada
- United States Food and Drug Administration (FDA)
- Japan's Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA)
MDSAP covers the requirements of:
- ISO 13485 (Medical devices – Quality management systems – Requirements for regulatory purposes)
- Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013)
- Japan Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No. 169)
- Quality System Regulation (21 CFR Part 820)
It covers all other specific requirements of medical device regulatory authorities participating in the MDSAP program, including registration, licensing, technical documentation review and adverse event reporting.
To start your transition to MDSAP or learn more about the benefits of the program, please contact:
Senior Global Marketing Manager
t: +1 201 448 0377
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.