SOUTH KOREA Law and Practice Contributed by: Keum Nang Park, Eileen Jaiyoung Shin, Eunkyoung Lyu and Soo Yeon Park, Lee & Ko
7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law and Relevant Enforcement Bodies The PAA and the MDA are the primary laws governing the import and export of pharmaceuticals and medi- cal devices, while the Customs Act and Integrated Public Announcement promulgated by the Ministry of Trade, Industry and Energy (MOTIE) pursuant to the Foreign Trade Act, apply the requirements of the PAA and MDA to the actual customs process. In principle, pharmaceuticals and medical devices manufactured abroad are subject to the same reg- ulations as those manufactured domestically. The importers of such products are responsible for obtain- ing the necessary licences from the MFDS, such as import business licences and marketing authorisation for particular products, and complying with all obliga- tions under the PAA or MDA, such as quality testing. In addition to the above, importers also need to register overseas manufacturing facilities and undergo inspec- tions of those facilities. A manufacturing business licence and manufactur- ing authorisations for particular products are required for the manufacture of pharmaceuticals or medical devices, whether for domestic use or export. Howev- er, manufacturing authorisations for pharmaceuticals or medical devices that are only exported, and not sold or distributed domestically, are exempted from certain requirements and do not require renewal. The MFDS regulates licences and authorisations for both pharmaceuticals and medical devices, while the Korean Customs Service enforces the relevant regula- tions at the point of entry for imports. 7.2 Importer of Record of Pharmaceuticals and Medical Devices Only those with an import business licence from the MFDS for pharmaceuticals or medical devices can act as their importer of record. In order to receive an import business licence for either pharmaceuticals or medical devices, the entity applying for the licence must fulfil certain require-
ments, such as having the required storage facilities, quality testing facilities and equipment, and person- nel such as import managers and safety managers. Additionally, local presence is required in order to hold an import business licence for pharmaceuticals and medical devices. 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices In principle, only entities with an import business licence and marketing authorisation for the particu- lar imported product can import pharmaceuticals or medical devices into Korea. Exceptions of varying degrees to this rule include imports for the treatment of rare diseases, emergency use, clinical trials, research and testing, and personal use. 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports The Customs Act requires those who import products required by law to have approval, a licence, labelling or fulfil other requirements for their importation to show proof of the fulfilment of such conditions to the head of the competent customs office, which for phar- maceuticals and medical devices are the requirements imposed by either the PAA (for pharmaceuticals) or the MDA (for medical devices) (see 7.1 Governing Law and Relevant Enforcement Bodies to 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices ). Whether the imported product is subject to the regu- lations and requirements of either the PAA or MDA would be determined by whether the product satisfies the criteria for pharmaceuticals or medical devices as defined in the respective acts. 7.5 Trade Blocs and Free Trade Agreements As of February 2025, Korea has entered into 22 eco- nomic partnership agreements and free trade agree- ments with other countries, all 22 of which (the RCEP and FTAs with Chile, Singapore, EFTA, ASEAN, India, the European Union, Peru, the United States, Türki- ye, Australia, Canada, China, New Zealand, Vietnam, Colombia, MERCOSUR, the United Kingdom, Israel, Cambodia, Indonesia and the Philippines) are in force.
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