South Korean Regulators to Require Clinical Data for Many Class IV Medical Devices

South Korea’s medical device market regulator, the Ministry of Food and Drug Safety (MFDS), will begin requiring clinical data for dozens of medical devices in January 2016 that currently can avoid such requirements if their equivalence to predicate devices already on the South Korean market can be shown.

Among the proposed list of device categories (link in Korean) for which MFDS plans to require clinical data in order to obtain market registration are:

  • Implantable pacemakers
  • Spinal internal fixation systems
  • Antitremor electrical stimulation systems
  • Mandibular prostheses
  • Implantable defibrillators
  • Iliac stents
  • Balloon catheters for cardiac treatments
  • Neurovascular stents
  • Laser angioplasty catheters
  • Saline breast prostheses
  • Implantable infusion pumps
  • Multifocal intraocular lenses

 

According to Emergo consultants in Seoul, all affected devices fall under the Class IV high-risk classification; the new requirements will only apply to future registrations.

For all affected devices, registrants will need to provide clinical data in addition to technical dossiers in Summary Technical Document (STED) format. 

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