Will Roche Be Among The First To Launch An Approved COVID Self-Test In Germany?
Roche's new CE-marked nasal-swab antigen test could be a good candidate for approval within Germany's recently liberalized COVID-19 self-test market.
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In Germany, a draft reguation circulated to industry associations proposes the sale of COVID-19 antigen tests directly to the public. If the amendment to Germany's medical devices regulations is approved, the onus will be on manufacturers to submit viable tests for approval, with the country's in-vitro testing industry association suggesting that this could be achieved in a matter of weeks.
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