Medical Devices Act Article 58

If any of the following circumstances is found to apply to any medical device, the medical device manufacturing or importing firm shall immediately notify medical institutions, other medical device firms, and pharmacies, and shall recall and handle marketed and stocked products within the specified time period:1. Where a license has been obtained or listing has been completed, but its manufacture or import is prohibited by announcement.2. Where the medical device is defective or has not been registered and approved or listed.3. Where the finding after inspection, testing, or other risk assessment is that there is likelihood to cause harm to the health of human body for users.4. Where the medical device manufacturing license has been cancelled by the central competent authority, or the medical device is manufactured or imported during the period when the medical device manufacturing license is not valid.5. Where the manufacture or import of medical devices violates the provisions of Articles 26, 32, or 33.6. Other circumstances in which a necessary recall is announced by the central competent authority.When the medical device manufacturing or importing firm recalls medical device of the preceding paragraph, medical institutions, other medical device firms, and pharmacies shall give their cooperation.Regulations governing the classification, approaches for recall operation, handling methods, and other matters to be complied with in regard to medical devices required to be recalled of Paragraph 1, shall be established by the central competent authority.