KGS KOREA

KGS KOREA

Medical Device Certification

Professional support for medical device clinical trials (CRO), sterilization validation, and related certification services.

USA (FDA)

Purpose

Medical devices sold in the United States must be registered with the FDA through establishment registration and device listing.

Owners or operators of facilities that manufacture or distribute devices for use in the US must register those facilities annually with the FDA (establishment registration).

Devices from registrable facilities must generally also be listed with the FDA (device listing).

Overview

The FDA classifies devices into Class I, II and III by risk. Higher classes face stricter controls. Product code searches show whether 510(k) exemption, 510(k), PMA or other submission types apply.

Class I

Most Class I devices are exempt from 510(k) (e.g. eyeglasses, toothbrushes). After completion they are FDA listed devices.

Class II

Most Class II devices require 510(k) (e.g. catheters, pulse oximeters). After clearance they are FDA cleared devices.

Class III

Most Class III devices require Premarket Approval (PMA) (e.g. pacemakers, joint implants). After approval they are FDA approved devices.

FDA logo

Class I – 510(k) exempt

Class I is the lowest-risk category. Most Class I devices are 510(k) exempt and may be marketed after establishment registration and listing.

Not all Class I devices are exempt; confirm submission type via product code search.

Class II – 510(k)

A 510(k) demonstrates substantial equivalence to a predicate device. After submission the FDA conducts acceptance, substantive and interactive reviews.

  • Intended use and indications for use
  • 510(k) summary
  • Device description
  • Labelling
  • Performance test data, etc.

Small Business Determination Program

Eligible small businesses may receive fee reductions for 510(k), PMA, BLA, De Novo and similar submissions. Establishment registration fees are not reduced.

Small business: including affiliates, gross income or sales of USD 100 million or less over the most recent three fiscal years.

Remarks

Article 51 (Penalties)

  • Any person who falls under any of the following shall be punished by imprisonment for not more than five years or a fine not exceeding 50 million won.
  • A person who obtained permission, certification or filed a report by false or other improper means under Articles 6(1)(2) or 15(1)(2)
  • A person who violated Article 26(1)
  • A person who obtained renewal under Article 49(3) by false or other improper means