Improved Korean medical device import declaration

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Improved Korean medical device import declaration
Improved Korean medical device import declaration

The Ministry of Food and Drug Safety and the Korea Customs Service have announced that the Medical Device Standard Pre-Clearance Notification, a pre-approval process required for importing medical devices, will become easier from 29 February.


Previously, the complainant had to manually enter 13 types of medical device licence information to the Korea Customs Service for the standardised pre-clearance notification of medical devices, but in the future, the information will be automatically entered by sharing the information with the Korea Medical Device Industry Association.


The improvements are the result of five months of inter-ministerial co-operation to make it quicker and more convenient for importers to import medical devices, which will help ensure a smooth supply of medical devices.


The Ministry of Food and Drug Safety (MFDS) and Korea Customs Service (KCS) have announced plans to expand the simplification of standardised customs pre-clearance reports in various fields, including drugs, cosmetics and human tissues, to speed up the import and customs clearance of medical products.



👉 Contact GCA

Tel. +82-31-360-8180
Email: forest.lee@gca-kr.com

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