Moon administration to ease medical device regulations to spur innovation
- 6 years ago
문 대통령, 의료기기 규제혁신 현장방문... 혁신성장 첫 행보
President Moon Jae-in went to a local hospital today where he announced the first step in a series of efforts for innovative growth.
The initiative begins with the field of medical devices.
There are certain products that should be easily accessible to patients.
But strict regulations made it difficult for these items to enter the market.
Cha Sang-mi has our top story.
The chair of the Korean Society of Type 1 Diabetes, who has a son with the disease, explained how she had to look abroad to order a device to check her little son's blood sugar without having to poke his finger to draw blood over ten times a day.
Her efforts were praised by President Moon Jae-in who was on a visit Thursday to a university hospital for a event related to his policy of pursuing innovative growth.
President Moon said this is just one of many cases where regulations keeping devices off the market for too long have caused patients and their families to despair.
"When it comes to the people's safety and bioethics, we should definitely take a careful approach. But when devices are already certified, we need to significantly lower the regulatory barriers and reduce the time it takes to get them on the market."
"The government regulates the medical device sector for the safety of the people. But the regulation process means bringing a new device from development to the market can take up to 5-hundred-20 days."
President Moon condemned the technical evaluation process as harder than actually inventing or developing a device.
He said he welcomes efforts to save lives and vowed to break with the sector's outdated practices and regulations.
He also promised to, first, allow high-tech medical devices to be launched quickly under a separate assessment procedure; second, to minimize the licensing process for already-certified invitro diagnostic devices by simply getting permission from the Ministry of Food and Drug Safety, which would cut the time it takes from over a year to less than 80 days.
Lastly, President Moon pledged to make the difficult licensing process easier by offering an integrated service for all three related agencies.
Cha Sang-mi, Arirang News.
President Moon Jae-in went to a local hospital today where he announced the first step in a series of efforts for innovative growth.
The initiative begins with the field of medical devices.
There are certain products that should be easily accessible to patients.
But strict regulations made it difficult for these items to enter the market.
Cha Sang-mi has our top story.
The chair of the Korean Society of Type 1 Diabetes, who has a son with the disease, explained how she had to look abroad to order a device to check her little son's blood sugar without having to poke his finger to draw blood over ten times a day.
Her efforts were praised by President Moon Jae-in who was on a visit Thursday to a university hospital for a event related to his policy of pursuing innovative growth.
President Moon said this is just one of many cases where regulations keeping devices off the market for too long have caused patients and their families to despair.
"When it comes to the people's safety and bioethics, we should definitely take a careful approach. But when devices are already certified, we need to significantly lower the regulatory barriers and reduce the time it takes to get them on the market."
"The government regulates the medical device sector for the safety of the people. But the regulation process means bringing a new device from development to the market can take up to 5-hundred-20 days."
President Moon condemned the technical evaluation process as harder than actually inventing or developing a device.
He said he welcomes efforts to save lives and vowed to break with the sector's outdated practices and regulations.
He also promised to, first, allow high-tech medical devices to be launched quickly under a separate assessment procedure; second, to minimize the licensing process for already-certified invitro diagnostic devices by simply getting permission from the Ministry of Food and Drug Safety, which would cut the time it takes from over a year to less than 80 days.
Lastly, President Moon pledged to make the difficult licensing process easier by offering an integrated service for all three related agencies.
Cha Sang-mi, Arirang News.