YTY Group is pleased to announce that it has recently been granted the Medical Device Single Audit Program (MDSAP) certification by governing body TÜV SÜD, Germany. This makes YTY as the first glove manufacturer within the industry to be audited against the MDSAP standard and to attain the MDSAP certification.
The MDSAP standard was developed by representatives of the Australian Therapeutic Goods Administration (TGA), Brazilian Health Regulatory Agency or Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, Japan's Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), and the U.S. Food and Drug Administration (FDA), and is expected to become the primary healthcare framework that regulatory agencies in advanced countries will look to align and build-upon.
The MDSAP certification was developed to enable regulatory oversight of medical device manufacturers’ quality management systems (QMS) while minimizing regulatory burden; promote more efficient and flexible use of regulatory resources while respecting the sovereignty of each authority; promote greater alignment of regulatory approaches and technical requirements; and promote consistency, predictability and transparency of regulatory programs by standardizing practices and procedures.
YTY has consistently demonstrated that it is at the forefront of regulatory certification trends, and has been a leading adopter of new standards, as and then they are issued, to reflect changing regulatory frameworks.
Please contact us, or your YTY Sales representative, to discuss this accreditation, or other regulatory requirements you may wish to address.