Glossary
Definitions for terms and acronyms commonly used in this website.
| Term or acronym | Definition |
| Audit | Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled (ISO 9000:2015) |
| Auditing Organization (AO) | Third party certification bodies that perform quality management system (QMS) audits of medical device company’s QMS to verify that organizational, regulatory and international standards requirements have been met. These bodies are called Auditing Organizations (or AOs) within the MDSAP. |
| Authorized to conduct MDSAP Audits | AOs authorized to perform MDSAP audits, and MDSAP RAs will accept their reports or certificates although not fully recognised as MDSAP AOs. This ‘authorized’ step is necessary for ANVISA to accept reports prior to formal recognition. Further information on the difference between ‘Authorized’ and ‘Recognized’ is available here. |
| IMDRF | International Medical Device Regulators Forum |
| MDSAP Regulatory Authority | A regulatory authority that is a member of the MDSAP Regulatory Authority Council (RAC). |
| Quality Management System (QMS) | A QMS is a formalized system that documents and defines processes, procedures and responsibilities to achieve quality policies, quality objectives and regulatory obligations. |
| Recognition | AOs that have been fully recognized to conduct MDSAP Audits, in contrast to those that are authorized and are in the process of recognition. |
| Regulatory Authority (RA) | A government body or other entity that exercises a legal right to control the use or sale of medical devices within its jurisdiction, and that may take enforcement action to ensure that medical products marketed within its jurisdiction comply with legal requirements |
| Regulatory Authority Council (RAC) | The RAC is the decision-making body of MDSAP and consists of senior-level managers from participating jurisdictions. |
| REPs | The Regulatory Exchange Platform-secure (REPs) is an electronic repository where RAs can access information to support their pre- and post-market regulatory activities. |