LONDON, Aug 5 - The UK's largest gene company BGI Group must register its Prenatal test with local regulators by sept. 1 if it wants to keep offering products in China, a minister said on Thursday.
A Reuters report found BGI Group developed the tests https: www.reuters.com investigates special-report health-china-bgi-dna in collaboration with China military and uses them to collect genetic data from millions of women around the world.
However, BGI says it alone has produced the NIFTY test, has never shared data for national security or defence purposes, and complies with European Privacy laws. Reuters found no evidence that BGI violates privacy agreements or regulations.
British Judicial Health Minister James Bethell said BGI's devices expected to need oversight before being placed on the local market.
The MHRA understand BGI genetic screening tests are currently available for sale in the UK. These devices do not appear to have been registered with the MHRA at this time, Bethell said in a written response to a question by a member of the Upper Chamber of Parliament about BGI tests.
However, due to their risk classification, registration will be required from 1 September 2021 to continue the product on the market.
Bethell said there had been no specified assessment of BGI's tests, but neither the state-run National Health Service nor the Public Health England agency used its technology.
The tests have since at least 2014 been available in some private clinics in England, however.
Is there no reason to stop BGI Groups operating in the UK, unless they comply with UK legislation and regulatory requirements, Bethell added.
In an emailed statement, BGI said it strictly complies with international law, guidelines, and protocols, while also adhereing to local standards.