SEOUL, July 10 (Korea Bizwire) — The government has announced plans to significantly strengthen the safety management of medical devices that are implanted into human bodies.
A new system will be set up to track medical implants from factory release until the surgical implant procedure.
The Ministry of Food and Drug Safety announced on Thursday the establishment of a new “Implanted Medical Device Safety Information Check System” that is expected to launch in November.
The new system is designed to track the entire process of a human-implanted medical device ranging from the moment when it leaves the factory to the stage when it is surgically implanted into a human body.
The ministry said that it would contribute to ensuring rapid response to the adverse side effects of medical implants, which can occur after they are released from factories.
In particular, this system would enable rapid tracking, retrieval and scrapping of medical devices with harmful side effects or defects.
The ministry added that the system would contain product and safety information on medical implants as a way to guarantee consumers’ ‘right to know’.
Kevin Lee (kevinlee@koreabizwire.com)