- TBG Diagnostics (TDL) has reported that its investee company, TBG Biotechnology Xiamen, will no longer be able to sell its COVID-19 test kit until it gains additional approvals
- The Chinese government has introduced new measures in a bid to stop the sale of faulty or fake COVID-19 test kits,
- The new legislation requires the diagnostic kits to have a China medical device product registration certificate in order to be sold in-country or exported
- Despite TBG Xiamen gaining CE mark approval allowing for the kits to be sold in Europe, all exports are now on hold
- TBG Xiamen does, however, intend to apply for the approval so that it can resume sales and exports
- TBG Diagnostics is in a trading halt, after a sudden spike in its share price which it claims was due to its investee company receiving CE mark approval for the test kits. Company shares last traded for 27 cents each.
TBG Diagnostics (TDL) investee company, TBG Biotechnology Xiamen, is unable to sell its COVID-19 virus diagnostic test kit due to new government laws.
A few weeks ago, the company was received a CE Mark to sell and export its COVID-19 diagnostic kits to the Europe region.
The Chinese Government has now banned the export of all COVID-19 diagnostic kits that have not obtained the required China medical device product registration certificate.
This new rule is to stop faulty or fake COVID-19 kits.
The company’s virus detection kits do not currently have the registration certificate it needs under the new export laws. Therefore the company is unable to sell and export its product.
While the product has received interest from several buyers, in light of these new restrictions no diagnostic test will be exported or sold as long as these restrictions remain in place.
TBG Xiamen will persist and apply for the relevant approvals to allow for the sale and distributions of the product.
TBG Diagnostics is in a trading halt, after a sudden spike in its share price which it claims was due to its investee company receiving CE mark approval for the test kits. Company shares last traded for 27 cents each