Includes bibliographical references and index.
|Other titles||Medical device vigilance, monitoring|
|Statement||Robin N. Stephens ; with contributions by Eddie F.J. van Eeckhoven.|
|Contributions||Eeckhoven, Eddie F. J. van.|
|LC Classifications||R856.6 .S74 1997|
|The Physical Object|
|Pagination||xvii, 198 p. :|
|Number of Pages||198|
|LC Control Number||96051891|
The Provisions for Medical Device Adverse Event Monitoring and Re-evaluation, approved by the State Administration for Market Regulation and the National Health Commission, is hereby promulgatedand shall be put into force as of January 1, • remove, i.e. recall the medical device or IVD from the market. The Regulatory Authority has established procedures for the ongoing monitoring, vigilance and recall for medical devices and IVDs supplied in South Africa. These guidelines are relevant only to medical devices and IVDs. Separate guidelines apply to the With over 30 years of experience, the Medical Vigilance Solutions team provides pharmacovigilance and medical communications outsourcing solutions to meet your changing needs. Powered by a staff of highly specialized pharmacists, nurses and allied health professionals, we offer a broad scale of services that fit seamlessly into your process Do you now the requirements and your responsibilities for medical device vigilance reporting Considerations To support compliance to the vigilance requirements listed in Table 1, it is important to consider the aspects of a quality system (such as ISO ) which allow for the collection of the appropriate information which will /LocalFiles/en-US/Whitepapers/
Medical devices safety monitoring. See the Australian regulatory guidelines for medical devices (ARGMD), Part 3, Section 22 for detailed information on post-market vigilance and monitoring requirements. Adverse events: Australian statistics on medical devices Statistics on adverse event reports relating to the use of medical devices in A medical device classification system is therefore needed, in order to apply to medical devices an appropriate conformity assessment procedure. In order to ensure that conformity assessment under the Medical Device Directive functions effectively, manufacturers should be able to determine A medical device may contain an ancillary medicinal substance to support the proper functioning of the device. These products fall under the medical devices legislation and must be CE marked. If the ancillary substance is derived from human blood or human plasma, or if it is within the scope of the centralised procedure for the authorisation of medicines, the notified body must seek a Emergo represents more than 1, medical device and IVD companies as an official EU Authorized Representative, so our team is constantly involved in helping companies with vigilance reporting. If we act as your European Authorized Representative, we can submit incident reports to /medical-device-vigilance-and-incident-reporting-europe.