Korea Certified Customs Attorney SJ

Just as in many countries, premarket approval is required for importing medical devices to Korea.   The premarket approval is classified into notification, certification, and approval depending on the class of a medical device and the requirement of clinical test. Outline of the premarket approval process is well explained in the webpage of the competent authority, MFDS (Ministry of Food and Drug Safety):   https://www.mfds.go.kr/mfds/eng/html/sub04/MFDS-DE01-10-26-L0001.jsp Apart from the premarket approval, as prescribed in the CONSOLIDATED PUBLICE NOTICE ( 통합공고 ), a document called “ 표준통관예정보고서 (SCCSR: Standard Customs Clearance Schedule Report)” shall be submitted to the KMDIA (Korea Medical Devices Industry Association) to import medical devices. In relation to the HS Codes where medical devices can be classified, SCCSR is designated to be checked by a customs officer during the import customs clearance under the NOTIFICATION ON DESIGNATION OF GOODS SUBJECT TO VERIFICATIO...

As carriers request MSDS (Material Safety Data Sheet) to ship a chemical product, MSDS prepared by its manufacturer or exporter may naturally be shared in importing the chemical product into Korea. In importing industrial chemicals, extra care is required because MSDS conforming to Korea standards shall be submitted to the Minister of Employment and Labor under the OCCUPATIONAL SAFETY AND HEALTH ACT ( 산업안전보건법 ). OCCUPATIONAL SAFETY AND HEALTH ACT Article 110 (Preparation and Submission of Material Safety Data Sheets) (1) A person who intends to manufacture or import any chemical substance or a mixture containing it, which is falling under the classification standards referred to in Article 104 (excluding a chemical substance or mixture prescribed by Presidential Decree; hereinafter referred to as “substances subject to material safety data sheet preparation”), shall prepare data sheets stating the following matters (hereinafter referred to as "ma...