For Class I medical devices, the process is straightforward. These devices go through an online notification system managed by the National Institute of Medical Device Safety Information (NIDS), and the notification is granted immediately without further review.

For Class II medical devices, the pathway varies based on whether the device is Substantially Equivalent (SE) or Not Substantially Equivalent (NSE) to existing devices. SE devices that conform to predetermined conditions are sent to testing laboratories, which issue a conformity notification, leading to certification within 5 days through NIDS. If the device does not conform to the predetermined conditions or includes modifications, it must be reviewed by a designated review agency, which takes approximately 25 days, after which certification is granted.

Class III and IV medical devices, must undergo a more rigorous evaluation process under MFDS. This includes a Technical Document Review, which takes approximately 65 days, and a Clinical Data Review, which may take up to 80 days. Following these evaluations, the device is considered for final approval. This tiered, scientifically grounded system ensures that the regulatory scrutiny matches the level of risk posed by the medical device, facilitating a predictable and structured approval process.

• The technical documents is consist of ‘Application Form’ and ‘Supplementary Evidence’. The presence of mandatory submission of ‘clinical trial reports’(as a part of ‘Supplementary Evidence’) determines application procedure to be followed.

• 2.1 General Technical Document Review
  • If a device is substantially equivalent legally marketed devices, ‘clinical trial reports’ are not required.

• 2.2 Safety and Efficacy Review(SER)
  • The technical document including ‘clinical tiral reports’ is thoroughly reviewed
    ‘Clinical trial reports’ are required if differences such as ‘Intended Use’, ‘Mechanism of Action(MoA)’ and ‘Raw Materials’ could significantly affect safety and efficacy of devices

Regulations on Labeling and Description of Medical Devices

(Firm-initiated Recall) Recall made usually voluntarily by the firm after the discovery of safety issues or product defects that may have potential health risk to patients.

(Government-initiated Recall) Recall order made by Minister of MFDS when the product is determined to be defective or potentially harmful.

Regulation on Prior Review of Advertisement on Medical Device

MFDS Quality Management System (QMS) regulations are made based on ISO 13485.

All medical device manufacturers required to comply with QMS regulations if their devices are distributed in Korea

On-site audits are mandatory for class 2, 3, and 4 devices manufacturers, but it is elective for class 1 device manufacturers