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Coronavirus: guidelines for 3D printing of respiratory device accessories

In order to assist those offering alternative methods of producing medical devices, the FAMHP has developed guidelines which will help guarantee patient safety and the performance of the products used.

Making COVID-19 tests available in Belgium

The FAMHP no longer provides specific validation or verification procedures for COVID-19 tests, nor are there any restrictions for making these tests available on the Belgian market.

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

An Alternative Test Protocol (ATP) has been developed for surgical face masks that do not have the necessary declarations, certificates and test reports. In the event of a positive result, this protocol still allows them to be used as a surgical mask or comfort mask. Test results are now also made public.

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: measures taken by the FAMHP and relevant partners to continue to guarantee oxygen supplies

Due to the COVID-19 pandemic, there is an increased need for oxygen in Belgium for patients with respiratory problems. The FAMHP and its relevant partners, assembled as part of the Task Force in charge of the management of medical devices and medicinal products, are taking measures to guarantee supply.

Coronavirus: circular for care institutions on the (outsourcing of the) manufacture and reprocessing of medical devices and their accessories

In order to combat shortages of medical devices, care institutions have proceeded to manufacture medical devices and their accessories or to reprocess used medical devices. The FAMHP defines the modalities by means of a circular in order to offer more options to care institutions.

Coronavirus: Belgian directive for the reuse of surgical masks and FFP2/FFP3 masks in the context of the COVID-19 epidemic

A national guideline is available for the reprocessing of surgical masks and FFP2/FFP3 masks which allows reuse by cleaning, disinfecting or sterilising.

Coronavirus: guidelines for checking the compliance and suitability of certain surgical face masks

The FAMHP issues guidelines for checking the compliance and suitability of surgical face masks The guidelines are for companies not producing in accordance with European standards and for healthcare establishments and authorities ordering the masks.

Operation PANGEA XIII: Belgian customs and the FAMHP seize 203 packages containing over 23 000 illicit or counterfeit products

The FAMHP, in collaboration with Belgian customs, took part in the international Operation PANGEA XIII from 3 to 10 March 2020. This operation, coordinated by INTERPOL, specifically targets the interception of illicit and counterfeit medicinal products and devices. In Belgium, inspections were performed at the Zaventem and Bierset control points.

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.

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