엠디웍스코리아

Purpose of the system

The purpose is to renew medical devices every five years to ensure efficient medical device management by conducting periodic reviews of safety and effectiveness after initial approval, certification, and reporting, and organizing items that are not manufactured or imported.

Legal basis

· Article 49 of the Medical Device Act, Articles 62 and 62-2 of the Enforcement Decree of the same Act
· Regulations on renewal of medical device manufacturing license, etc.

Renewal target

Medical devices of all classes that have been approved, certified or reported, but medical devices for export that are produced or imported solely for export purposes or
medical devices with conditional approval, certification or report are excluded.

Renewal application deadline

Application must be submitted 270 to 180 days prior to the expiration date of the manufacturing license, etc.

Renewal criteria

· There will be no significant problems with the safety or effectiveness of the medical device.
· Regulations on renewal of medical device manufacturing license, etc.
· There must be a production or import performance record for the medical device in question.
· Must have faithfully complied with medical device related laws and regulations
· In addition, it shall conform to the standards similar to the above standards and shall be stipulated and announced by the Commissioner of the Ministry of Food and Drug Safety.

Required document