Korean Medical Devices Gain Global Recognition as MFDS Added to WHO’s Interim List of High-Performing Regulatory Authorities

South Korea’s Ministry of Food and Drug Safety has further strengthened international confidence in Korean medical devices after being added to the World Health Organization’s (WHO) interim list of high-performing regulatory authorities for medical devices.

According to a report released on the 28th by the KoreaBIO Economy Research Center, the WHO announced its interim list of high-performing regulatory authorities (tWLA) for medical devices on the 14th. The list includes regulatory authorities from 12 countries and regions, including South Korea’s MFDS, the United States, the European Union (EU) and Japan.

The medical device tWLA is an interim measure recognizing authorities with verified regulatory capabilities until the formal high-performing regulatory authority (WLA) accreditation process is completed. It is part of the transition from the existing “stringent regulatory authority (SRA)” system to the WLA system and aims to strengthen confidence in regulatory authorities.

The WHO’s WLA framework was introduced to provide an international recognition pathway for regulatory authorities that achieve a high level of performance. It is expected to improve access to safe, effective and high-quality medical products while enabling the efficient use of limited regulatory resources.

In October 2023, the MFDS became the first regulatory authority in the world to be added to the WHO’s list of high-performing regulatory authorities (WLA) for medicines and vaccines. Its addition to the interim list for medical devices further demonstrates the strength of its regulatory capabilities.

The authorities designated this time will move from the tWLA list to the formal WLA list if they successfully complete the WHO’s evaluation process. In addition to South Korea, the tWLA list includes regulatory authorities from Australia, Brazil, Canada, China, Japan, Russia, Switzerland, Singapore, the United Kingdom and the United States.