Viet A Company's test kits
Accordingly, Dr. Kidong Park, the World Health Organization Representative in Vietnam, said that Viet A Company has submitted an application of its product of Covid-19 PCR test kit for an in vitro diagnostic product for emergency use list whose registration file number is EUL 0524-210-00.
However, this product profile has been evaluated that it failed to meet the required safety, performance, and quality management system records of the medical device.
According to Dr. Kidong Park, WHO’s pre-screening mechanism to assess the safety, quality, and effectiveness of essential medical products includes in vitro diagnosis IVD; drugs, vaccines, equipment used in vaccination, and equipment in the cold chain.
The pre-screening process for each product line is evaluated transparently and scientifically, including reviewing records, testing products, evaluating performance and checking production facilities’ research performance. WHO has also developed a EUL process to take advantage of the availability of medical products (vaccines, diagnostics...) that need to be used in public health emergencies. This process is intended to assist suppliers and member states in decision-making when using specific products. The WHO Emergency Use Listing Procedure (EUL) is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics, and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency.
According to the published WHO emergency use list for IVD diagnostic equipment, 28 IVD Covid-19 diagnostic products have been approved through the WHO EUL IVD process as of December 20, 2021.
Additionally, 46 other products do not meet the required safety, performance, or quality management system records. Viet A Company’s test kits are among the 46 products that do not meet requirements.