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Coronavirus: newly updated guidelines for verifying the compliance and suitability of surgical face masks

The FAMHP has issued guidelines for checking the compliance and suitability of surgical face masks during the COVID-19 crisis. These guidelines are intended for companies, institutions and authorities that order, sell or use these masks.

Coronavirus: Alternative Test Protocol (ATP) for surgical face masks

The FAMHP inspection services have noted that the surgical face masks offered do not have the declarations, certificates and test reports necessary according to European or international standards. For this reason, an Alternative Test Protocol (ATP) has been developed to ensure they can still be permitted for use as a surgical mask or comfort mask.

Coronavirus: ban on the sale of rapid diagnostic tests due to the risk of misinterpretation

In order to avoid misinterpretation of negative results, the FAMHP has banned the use of rapid coronavirus (COVID-19) diagnostic tests for six months.

Recall of batches of COCUNE brand mitt-type body wipes

The FAMHP would like to inform consumers and patients of a recall by Stöpler Medical B.V. concerning COCUNE brand mitt-type body wipes. This is a repeat of a safety alert previously issued by the FAMHP that may have escaped the attention of some consumers and patients.

Product recall of batches of Durex Natural Feeling Extra Lubricated and Durex Real Feeling latex-free polyisoprene condoms

The FAMHP would like to remind consumers and patients about a recall by Reckitt Benckiser of Durex Natural Feeling Extra Lubricated condoms and Durex Real Feeling latex-free polyisoprene condoms. This is a repeat of a safety alert previously issued by the FAMHP that may have escaped the attention of some consumers and patients.

Safety information concerning Philips ear thermometers

The FAMHP would like to relay safety information concerning two types of ear thermometer to consumers and patients. This is a repeat of a safety alert previously issued by the FAMHP that may have escaped the attention of some consumers and patients.

Information sessions on auto control of the sector of medical devices - 8th September and 2nd October 2017

The Directorate-General INSPECTION of the FAMHP organises two information sessions on Friday 8th September and Monday 2nd October 2017 in the Storck room, SPF Emploi, 1 rue Ernest Blerotstraat, 1070 BRUSSELS.

Dispositifs de fermeture de communication interauriculaire fabriqués par NMT Medical, Inc. : recommandation

L’Agence Fédérale des Médicaments et des Produits de Santé (AFMPS) a été informée par les autorités suisses que l’entreprise américaine NMT Medical, Inc., qui fabriquait des dispositifs médicaux de fermeture des communication interauriculaire, a déposé son bilan en avril 2011. Suite à cette fermeture, les exigences légales, notamment en matière de surveillance du marché, ne sont plus respectées. Il est donc recommandé de ne plus utiliser ces dispositifs.

Implants mammaires de POLY IMPLANT PROTHESE : suivi et conclusions

En avril 2010, l’AFMPS a publié un communiqué relatif aux implants mammaires fabriqués par la société Poly Implant Prothèse (P.I.P.). Elle demandait alors aux distributeurs de ces implants, aux pharmaciens, aux médecins et aux personnes qui en détenaient d’en arrêter la distribution, la délivrance, l’utilisation et l’exportation, étant donné que le gel de silicone utilisé ne correspondait pas au gel approuvé. En novembre 2010, l’AFMPS a publié un nouveau communiqué pour relayer les premiers résultats des tests réalisés par l’Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS). Récemment, l’AFSSAPS a publié les derniers résultats et ceux-ci confirment les

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