COVID-19 updates and news
As the impact of the coronavirus (COVID-19) pandemic on the industry continues to unfold, we understand that the impact COVID is having on the people and companies serving the industry. We are in a rapidly evolving environment and therefore we would endeavour to keep you abreast of news, recommendations, and changes from Europe, China and the US FDA.
As global Medtech professionals, supporting companies who are taking care of our Healthcare in a world that is facing an unprecedented situation and the health and safety of people worldwide is a priority.
We have experience with the Humanitarian Exemption routes in China, US, and EU, as well as in other countries around the world. We are happy to share this info and help you to find market access. Please contact our colleague Danielle Motta if you have specific questions regarding the humanitarian exemption route and process.
Importing face masks into the European Union?
Due to the Covid-19 crisis the demand
for face masks is increasing, especially
now governments lift lockdowns and
start advising their citizens to wear face
masks in public, to help prevent the
spread of the virus. These face masks
are among the so-called ‘harmonized
products’ for which there is a specific EU
product legislation in place.
Market access for Covid-19 Self- testing kits
Lockdowns are step-by-step lifted. Governments are increasing the number of tests. At the same time, the market for self-tests is growing quickly; consumers want to know if they have it or not. And they want to check this regularly.
Getting involved with self-testing kits is complex. It may not be your everyday product
compliance process. It involves paperwork, time, money, patience. There are no quick
routes to the market.
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