News Details
South Korea Notifies WTO of Proposed Amendment to Medical Device Labelling Rules
On November 15, 2024, the South Korean Ministry of Food and Drug Safety (MFDS) notified the World Trade Organization (WTO) of a proposed amendment to the “Regulation on Labelling and Description of Medical Devices". The purpose of the amendment is to increase efficiency and reduce burdens on the industry by allowing manufacturers to include only the primary contact or visit address on the container or package of medical devices.
Key Updates
A. Improvements to the writing of the address on the container or package (Article 6):
Based on the manufacturing/import business license, an address that can be contacted or visited at any time can be selected as the primary address on the label.
B. Changes in terminology to reflect current regulations (Articles 8 and 9):
Reflects names of websites where one can check matters related to permission, certification, and reporting (Medical Device Electronic Civil Service System) and code for video conversion of voice and sign language, and sign language terms.
Public Consultation and Enforcement Timeline
The amendment will be open for comments for 60 days from the date of notification. The proposed date for adoption and enforcement of the amendment will be announced at a later date.
We acknowledge that the above information has been compiled from WTO.
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