To engage in the importation of medical devices in South Korea, it is crucial to understand the regulatory requirements and obtain the necessary licenses and certifications. This comprehensive guide outlines the essential steps to secure an import business license from the Minister of Food and Drug Safety and comply with all relevant regulations. 

Anyone looking to import medical devices must first obtain an import business license from the Minister of Food and Drug Safety. This license is essential for conducting business legally and is a prerequisite for further regulatory approvals. 

Import Licenses, Certifications, and Reporting 

Once granted an import business license, the importer is required to obtain either an import license or import certification, or to file an import report for the medical devices intended for importation. The specific requirements depend on the risk classification of the medical device. 

Facility and Quality Management Requirements 

Applicants seeking an import business license or those applying for import approvals and certifications must be equipped with facilities capable of conducting quality inspections. They must also adhere to a quality management system as prescribed by the Decree of the Prime Minister.

However, there are exceptions for cases such as subcontracting quality control tests, as outlined by the Decree. 

Regulations for Combined Medical Devices in South Korea

In cases where a medical device is combined with a drug or quasi-drug and functions similarly to a drug or quasi-drug, if a license or report has been previously granted or filed under Article 42, Paragraph (1) of the Pharmaceutical Affairs Act, the import license or certification will be considered granted, and the import report will be deemed accepted. 

Conclusion 

Navigating the importation process for medical devices involves understanding and meeting regulatory requirements, including obtaining the necessary licenses and certifications. Ensuring compliance with these guidelines is crucial for successful importation and market entry.