Manufacturing & Import Business Licences.

We help medical device manufacturers obtain a Korean manufacturing business licence by meeting applicable regulatory requirements. This includes preparing manufacturing facilities, establishing a quality management system (QMS) and developing operating procedures in accordance with Annex 2 of the Enforcement Rule of the Medical Devices Act (manufacturing and quality management system requirements).
We assess the manufacturing environment and equipment against regulatory requirements and support document preparation, submission and responses throughout the licensing review.

We help medical device importers comply with Article 33 of the Enforcement Rule of the Medical Devices Act (obligations of importers). Our support covers the procedures required to establish an appropriate quality management framework for supplying safe, reliable devices to the Korean market.
We manage document preparation, submission and responses to the import business licensing review, assess importer obligations and help resolve regulatory questions.