In anticipation of the European regulations on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746), the FAMHP has updated the “My company” and “My activities” applications in its web portal.
Coronavirus: updated Belgian directive for the reuse of surgical and FFP2/FFP3 face masks during the COVID-19 pandemic
The national directive published on 07.04.2020 concerning the reprocessing of surgical and FFP2/3 face masks has been updated. This directive aims to guide the validation of the various initiatives being put in place regarding the reuse of surgical masks and personal facial protection.
Following the recommendations of the Belgian National Security Council regarding the coronavirus epidemic, the FAMHP encourages employees to work more from home. Therefore, we ask all our partners to submit their files to us electronically as much as possible.
Following the coronavirus epidemic (COVID-19), experts at FAMHP are actively monitoring the potential impact on the availability of medication and medical devices in Belgium. The FAMHP is also supporting the European Medicines Agency (EMA) in developing COVID-19 vaccines.
The American Food and Drug Administration (FDA) has recognised the FAMHP as its Belgian counterpart under the mutual recognition agreement (MRA) between the European Union and the United States.
The federal agency for medicines and health products (famhp) will soon launch a first satisfaction survey to assess the quality of its services and products. The results of this will be communicated at the end of 2013 and will be used to improve the delivery of FAMHP services.