14th April 2020 Author: Paul Carton
How to Find Which COVID-19 Test Kits Are Approved for Export
There have been recent reports in various national media outlets from countries across Europe, that government health departments have had to return some COVID-19 test kits to the manufacturer, with some of these based in China.
Buyers were dissatisfied with the product due to the lack of accuracy and hence false-negative results. However, manufacturers of the kits tried to explain the kits were not being used as intended.
As a precautionary measure, many national regulatory agencies have established assessment procedures for COVID-19 diagnostics. In particular, China has now informed the international community, that if they are buying a COVID-19 test kit from them, make sure the China National Medical Products Administration has approved them for export.
Effective from the 1st of April, licensed manufacturers who export medical products on their own must have licenses ready and have their products tested to be eligible for export. Trading companies must have the manufacturer’s business license and NMPA certificate as well as a certification from an authorized testing lab.
As there is a growing need for these medical products all over the world, there is likely to be an increase in the number of licensed manufacturers.
Rapidmicrobiology.com are updating the COVID-19 supplier's tables on our test method guide accordingly.
The World Health Organization are observing the work of the International Medical Devices Regulatory Forum (IMDRF). The forum is made up of medical device regulators from around the world who are submitting lists of approved kits to the World Health Organization for sharing within the community. You can view the latest document here.
Date Published: 14th April 2020
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