Welcome to HosmaT
The medical devices vigilance site

"The purpose of medical device vigilance is to improve the protection of health and safety of patients, users and others by reducing the likelihood of the same type of adverse incidents being repeated in different places at different times. This is to be achieved by the evaluation of reported incidents and, where appropriate, dissemination of information which could be used to prevent such repetitions, or to alleviate the consequences of such incidents".
Medical device vigilance therefore includes adverse incidents notification as well as recording, evaluation and exploitation of the information reported in order to improve prevention.

France : Incidents / Alerts reported and notified since 1998
Add your name on our list and receive up-to-date information regarding publications (circular letters, decrees…)
France : The cerfa notification form

 EEC : GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
EEC : Demarcation between MEDICAL DEVICES DIRECTIVES and
MEDICINAL PRODUCTS DIRECTIVES
EEC : MEDICAL DEVICES WITH A MEASURING FUNCTION

Other Vigilance :

Germany : DIMDI
Australia : NSW Health
Canada :

Medical device alerts
Warnings

Great Britain : Medical Devices Agency

Adverse Incident Reports : 2000 / 2001
Device Alertes
Hazard Notices
Safety Notices
Committee on Safety of Medicines
Urgent Communications / Chief Medical Officer

USA : Food and Drug Administration

Safety Alert
CDRH

Any incidents or risks of incidents should be reported MANDATORILY and immediately by the means of the form (see below) which may be obtained from the Ministry :

Click here in order to display the notification form (pdf)

AGENCE FRANCAISE DE SECURITE SANITAIRE DES PRODUITS DE SANTE
Unité Matériovigilance
143 / 147 bd Anatole France
93285 ST DENIS CEDEX
FRANCE

Fax : 33 1 55 87 37 02

site - http://www.hosmat.com - - last update : 06-28/2002