Medical Devices Act Article 13

Unless otherwise specified, those other than medical device firms shall not engage in the business activities specified in Article 10 and Article 11.Any business with the intent to become a medical device firm shall file an application with the municipal or county/city competent authority for approval and registration, and shall start the operation only after having obtained the business permit. In case there are any changes made in the particulars registered, the firm shall apply for change of registration.Medical device firms shall manufacture, sell, or supply medical devices at the registered place. Those who set up a separate manufacturing facility or business establishment shall file a separate application for medical device firm registration in accordance with the provisions of the preceding paragraph; however, those announced by the central competent authority shall not be required to apply separately for a medical device dealer permit at the business establishment or for selling or supplying medical devices at the registered place.If the medical device firms set forth in the second paragraph do not have any company registration or business registration, they need to submit a consent letter from the competent authority of the target business.Medical device firms set forth in the second paragraph shall join the trade association in accordance with the Industrial Group Act or Commercial Group Act.