The COVID-19 global pandemic has severely affected national health systems, which have therefore experienced an unprecedented crisis. Hospitals often had to cope with the fact that purchasing medical devices is not as immediate as it was in the past. The increased worldwide demand and the borders closures have led to significant delays in the procurement of devices.
Competent authorities are adopting different approaches to ensure the safety of devices on the European market and to prevent possible shortages. In this regard, the Belgian FAMHP published on its dedicated COVID-19 website, a guidance document listing devices that are considered critical for the treatment of a “standard COVID-19 patient”. In this list we can find devices that are used in the Intensive Care Units for different therapy approaches.
The FAMHP is going to constitute a strategic stock for those devices, in order to prevent possible shortages in hospitals in the short and medium terms.
If you are a medical device manufacturer of one or more of the devices on the list, you can fill the survey created by the Belgian Authority, specifying the number of devices in your stock and the delivery times to Belgium.
In this way, the crisis unit will have a better understanding of the Belgian market situation and will be able to directly contact the manufactures in order to buy devices for the strategic stock. Is important to specify that the devices on the list will be updated accordingly with the hospitals’ future requests.
Regulatory Affairs Department
If you need any advice for placing your devices critical for COVID-19 response on the European market, Obelis will be happy to act as your European Authorised Representative and support you in this process in an expedited manner!