Korea's Ministery of Food and Drug Safety has been included on the World Health Organization (WHO) temporary list of good regulatory authorities for medical devices (tWLA). Alongside major regulators such as the United States and the European Union (EU) and Japan, it has been recognized internationally as a trustworthy medical device regulator.
On the 28th, according to the Korea Biotechnology Industry Organization and other industry groups, WHO said on the 14th (local time) that it announced the list of Transitional WHO Listed Authorities (tWLA) in the medical device field.
The list includes 12 national and regional regulatory authorities in total, including Korea's Ministery of Food and Drug Safety, the U.S. Food and Drug Administration (FDA), the European Medical Devices Regulatory Network, Japan's Ministry of Health, Labour and Welfare and Pharmaceuticals and Medical Devices Agency (MHLW·PMDA), the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA), Canada, Australia and Switzerland.
WHO plans to transition authorities that complete the evaluation process from the temporary list to formal WLAs.
The tWLA is a transitional system WHO operates ahead of introducing the formal WHO Listed Authority (WLA) program in the medical device field. It first recognizes authorities with a certain level of regulatory capacity and track record to enhance international regulatory trust, then transitions them to formal WLAs after evaluation.
The WLA is a system in which WHO assesses a regulator's review capability and quality management system and recognizes it as an authority that can be trusted internationally. Other countries' regulators or international organizations can refer to that authority's review results, which is expected to streamline the authorization and procurement processes for medical products.
Ministery of Food and Drug Safety was listed in 2023 as a formal WHO WLA in the fields of pharmaceuticals and vaccines, the first in the world. This time, by being included on the temporary list in the medical device field as well, its regulatory capacity has once again been recognized.