The revised COVID-19 in vitro diagnostic device guidelines

Jeong Ho-sang, director of in vitro diagnostic equipment at the Ministry of Food and Drug Safety

Five people examine 800 companies' in vitro diagnostic devices

Due to the prolonged COVID-19, the in vitro diagnostic devices of the MFDS and the Korea Food and Drug Safety Evaluation Institute were very busy.

 

Since the outbreak of COVID-19, the export performance of in vitro diagnostic medical devices has increased by 1.5 times, and the degree felt by in vitro diagnostic departments is said to be 10 times.

 

Currently, in vitro diagnostic devices are operated on a small scale with four researchers and five examiners.

 

However, five examiners are reviewing the workload for approval of in vitro medical devices from 800 companies.

 

Jung Ho-sang, head of the in vitro diagnostic device division, said in a briefing to the journalists on the 26th, "Before COVID-19, there were many complaints about imported products of in vitro diagnostic devices used in hospitals." "However, after COVID-19, the development and permission management of product lines that used a lot and had a lot of complaints have decreased, and the situation has become to focus on COVID-19," he explained.

 

He said, "The number of applications for permission from companies that have no experience in developing COVID-19-related devices has increased, resulting in a surge in complaints." "It is not easy to replenish manpower, so there are many difficulties," he said.

 

Fortunately, applications for permission for new products have not increased despite the current COVID-19 resurgence.

 

Foreign companies are reportedly putting in complaints for permission for cancer diagnosis and blood diagnosis devices, which have been stopped while focusing on developing COVID-19-related devices.

 

Manager Jeong said, "Foreign companies are focusing on COVID-19 and restarting devices such as cancer diagnosis and blood diagnosis, which have rarely been developed.

 

There are still many applications for permission for COVID-19-related devices, but foreign companies have completed the development of COVID-19 diagnostic test kits and are receiving a lot of complaints about devices that have already been developed or have now begun." There was also an explanation of the recently revised guidelines for the approval review of COVID-19 in vitro diagnostic devices.

 

The MFDS deleted design restrictions that detected two or more genes only for COVID-19 gene test reagents, and added data on major mutation virus detection performance evaluation designated by the WHO as a prerequisite.

 

He explained, "It is not true that the revision of the guidelines eased the criteria for approval of test reagents." Regardless of the revision of the guidelines, the COVID-19 gene test reagent must meet the same licensing criteria as before regardless of the number of detected genes, he said.

 

"The clinical performance criteria with a sensitivity of 95% or higher and a specificity of 97% or higher are applied without change." In Korea, 46 gene test reagents have already been approved to detect two or more genes, and he added, "In accordance with the Korea Centers for Disease Control and Prevention's diagnosis guidelines, more than two genes are tested, so it does not affect the COVID-19 diagnosis system at all." However, as products targeting multiple genes are advantageous in detecting mutations in response to the new mutation virus, it is expected that the development of products targeting multiple genes will continue under the current epidemic and the Korea Centers for Disease Control and Prevention's diagnostic guidelines.

 

Regarding the deletion of design restrictions on genetic test reagents, he said, "We decided that there was no need to limit the design of genetic test reagents anymore because many genetic test reagents were performing well at home and abroad." He said, "This is to promote the development of new products and additional product types according to changes in the COVID-19 quarantine situation."