Good News! MDSAP Certificate Achieved Certificate Number: 700480

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On 18th October 2019 Vitalograph received the Medical Device Single Audit Program (MDSAP) Certificate, following a process commenced over two years ago and a series of rigorous audits in our Ennis facility in 2019.

The Medical Device Single Audit Program (MDSAP) is a global certification system that allows the conduct of a single regulatory audit of a medical device manufacturer's quality management system to satisfy the requirements of multiple regulatory jurisdictions. It allows a MDSAP recognized Auditing Organization, in our case the BSI, to conduct a single comprehensive regulatory audit, instead of each regulatory authority carrying out its own individual audit of the facility.

The MDSAP programme centres on adherence to the Quality Management Systems (QMS) Standard for
Medical Devices ISO 13485: 2016, along with additional requirements from five participating countries. It
provides a means by which medical device manufacturers can have a single audited programme to prove
compliance with the standard and regulatory requirements of the (currently) five different medical device
markets: The United States of America, Australia, Brazil, Canada and Japan. It does not replace ISO 13485, which remains the baseline of our quality management system.

International participants currently in the MDSAP:

  • USA FDA (accepts MDSAP as a substitute for routine FDA Agency inspections)
  • Therapeutic Goods Administration of Australia (TGA)
  • Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
  • Health Canada (HC)
  • Japan’s Ministry of Health, Labour and Welfare, (MHLW), and the Japanese Pharmaceuticals and Medical Devices Agency (JPAL)
  • The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs)Programme and the European Union (EU) are Official Observers

The programme is voluntary for the other regions but Canada has mandated that manufacturers who sell medical devices (Class 2 or higher) in Canada after 1st January 2019 must have a QMS that has been approved through the MDSAP programme.

MDSAP should offer faster market access in Brazil - by demonstrating that the devices are in compliance with the quality management and regulatory requirements which are applicable in Brazil. This should help with the Brazilian registration authority, because ANVISA accepts the MDSAP certification audit report as basis for preparation of a BGMP (Brazilian Good Manufacturing Practice).

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