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Coronavirus – a new validation procedure for serological tests

In April 2020, the Belgian Federal Agency for Medicines and Health Products (FAMHP) and Sciensano set up an extraordinary validation procedure for serological tests for SARS-CoV-2. The procedure turned out to be effective during the initial phase of the pandemic. The situation being experienced by the manufacturers and distributors of these tests and by the clinical laboratories carrying out the tests has now returned to normal. This is why a staged return to the conventional way of working is now being implemented.

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

The FAMHP is keeping a close eye on the situation on the ground. Consequently, the Alternative Test Protocol (ATP) is being adapted. From now on, it will no longer be possible to sell surgical masks which do not comply with the ATP as comfort masks. One of the parameters has also been refined based on an evaluation of the new test results. Furthermore, masks that have been subject to the ATP must carry a warning on the packaging. The third version of the ATP is applicable from 04.06.2020.

Web portal - updates to the “My company” and “My activities” applications

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 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. The guidelines are intended for companies, institutions and authorities that order, sell or use these masks.

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.

COVID-19: electronic files submission

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.

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