South Korea Rules on Emergency Production and Distribution of Medical Products

Regulators in South Korea have introduced policies and procedures ordering the production and distribution of medical products during a public health emergency (PHE).

The Ministry of Food and Drug Safety (MFDS) has issued Notice No. 2022-71 to enact the Regulation on Emergency Production and Import Orders and Distribution Improvement Measures for Public Health Crisis Response Medical Products, effective September 29, 2022.

This regulation prescribes procedures and methods for ordering the production and import of medical products, including medical devices and in vitro diagnostic devices (IVDs), to respond to the public health crisis, as well as measures to improve the distribution of these products in South Korea.

In particular, the regulation includes:

• Details to be given to a manufacturer or importer when ordering for emergency production or import
• Requirements for manufacturer or importer when reporting production or import plans and results
• Details to be given to specific operators (e.g., medical device vendors) when taking measures to improve the distribution of public health crisis response medical products for which supply has been determined to be significantly disrupted
• Reporting requirements for those who have received distribution improvement measures (i.e., reporting results of distribution improvement measures)

Why is this regulation regarding emergency PHE medical device ordering being enacted?

The MFDS has said that its intention behind enacting this regulation is to set forth the necessary process for which emergency production import orders and distribution improvement measures for responding to a public health emergency (PHE) are to be handled. There are two main parts of this regulation.

First, an emergency production and import order establishes a notice to the manufacturer and importer if he or she orders the production or import of a public health crisis medical products. Second, the regulation establishes the details and methods of submission included in the production and import plan and results report of the manufacturer and importer of crisis response medical products. Lastly, in the case of distribution improvement measures, the company shall determine the matters to be notified to the seller, etc., and determine the details and methods of submission included in the report of the results of the person who has received the distribution improvement measures.

Emergo by UL will continue to post updates to MFDS guidance as they become available.