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Sansure Biotech's monkeypox nucleic acid detection kit was certified by the British MHRA

2022/8/23 15:19:20 Views:280

Recently, the monkeypox virus nucleic acid detection kit (PCR-fluorescent probe method) independently developed by Sansure Biotech has passed the British MHRA certification. This is another authoritative certification obtained after the EU CE.


As of August 18, 2022, WHO has reported nearly 40,000 monkeypox cases in 94 countries and regions around the world. Earlier, Director-General Tedros Adhanom Ghebreyesus declared the monkeypox outbreak  "a public health emergency of international concern".


The monkeypox virus has a short incubation period, a fast transmission speed, and a complex mode of transmission. The monkeypox epidemic in European and American countries such as the United States, Spain, Brazil, Germany, and the United Kingdom is relatively serious. Cases have occurred in Chinese neighboring countries such as Thailand and Vietnam, and monkeypox has also been found in Taiwan, China. Pox cases, need to be alert to the risk of monkeypox virus transmission in China.


Why does Sansure Biotech need to register with the UK MHRA now?


At present, the UKCA certification is still in the transition period. Before July 1, 2023, Chinese manufacturers can contact IVDEAR to quickly complete the UK registration through the original CE certificate. After July 1, 2023, the UK will fully launch UKCA certification, and the original CE certificate will not be recognized by the UK, and the UK certification must be completed through the UKCA notified body.


About one week after the UKCA registration is completed, the manufacturer's information will be published in the MHRA public database for British dealers and importers to inquire, helping dealers and importers to quickly establish contact with British customers.


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At the same time, its registered products will also be announced to this website in one to two months.