South Korea MFDS Plans Several Medical Device Regulatory Updates for 2022

Notable Medical Devices Act amendments

First, MFDS has announced (link in Korean) three significant amendments to South Korean medical device regulations for next year. These changes include:

• Sealing of medical devices: Devices inserted into the human body or that are likely to deteriorate or degrade once opened will require seals; no such devices with opened or unsealed packaging may be sold on the South Korean market effective January 21, 2022.
• Fines for violations: Fines for violation of the Medical Devices Act will be adjusted as of January 21, 2022.
• Insurance: Adjusted requirements for manufacturers of particular devices to purchase insurance in order to compensate for damages stemming from serious injury or death of patients related to use of these devices will come into effect starting July 21, 2022.

Expanding eligibility for electronic indications for use (IFU)

Second, MFDS has added (link in Korean) to its list of devices for which manufacturers may provide IFU information via electronic formats such as webpages. The regulator has added 203 devices to the list, which means there are now 2,142 devices eligible for electronic IFU allowances.

Additional South Korean medical device regulatory resources:

• Korea License Holder (KLH) in-country representation
• Korea Good Manufacturing Practice (KGMP) quality management system compliance