The global demand for novel coronavirus diagnostic kits continues to maintain a high level, especially in 2021, the demand for antigenic kits shows a significant upward trend. Europe has established a white list system for antigen reagents. For professional antigen testing reagents, in addition to completing CE registration, they also need to be whitelisted and sold to EU member states. For test kits used by non professionals, also known as self inspection test kits, according to the requirements of the IVDD directive, a certificate from the notified body should be obtained. Given the limited number of institutions currently accepting such certification applications and the urgent need, various countries have adopted special approval policies. Among the policies of all member countries, Germany's bfarm and Pei are the most influential.

According to reports, bfarm and Pei have received nearly 1000 applications worldwide so far, with less than 30% of applications approved.

Jucheng Group's product has been included in the white list of BfArM in Germany