PHC Receives Conditional Approval for COVID-19 Rapid Antigen Test Kit
[Asia Economy Reporter Lee Chun-hee] PHC announced on the 26th that its affiliate Philosys has started domestic sales of the COVID-19 rapid antigen test kit ‘Gmate Covid-19 Ag,’ which received conditional manufacturing approval for domestic consumption from the Ministry of Food and Drug Safety on the 25th.
The approved product uses a rapid diagnostic method and is already in use in many overseas countries, including Malaysia. Recently, as it has obtained approval for rapid diagnostic kits in multiple countries such as Thailand, Germany, and Russia, it is expanding its sales channels in the global market and has succeeded in obtaining conditional approval from the Ministry of Food and Drug Safety.
Regarding the conditional approval rather than full approval, PHC explained that Philosys only holds GMP (Good Manufacturing Practice for medical devices) certification for its existing blood glucose meters and does not have GMP certification for rapid diagnostic kits.
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The company stated, "The related review is currently underway," and explained, "This conditional approval is equivalent to domestic approval, with the condition that the GMP certificate must be submitted by 2024." They added, "Since both the existing blood glucose meters and rapid diagnostic kits are classified as Class 3 medical devices and hold multiple overseas approvals, we expect the process to be completed smoothly."
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