Medical Devices Act Article 56

In the case of any defective medical device or medical device that has not been registered and approved or listed, the following measures shall be undertaken according to the circumstances in addition to the actions to be taken under applicable provisions of this Act:1. For those that manufacture or import medical devices that have not been registered and approved or listed or that use the licenses of others, the original approving authority may cancel all or part of their medical device licenses or listings, medical device business permits, medical device manufacturing licenses, or registered particulars regarding the company, business, or factory.2. For those that sell or display with the intent to sell medical devices that have not been registered and approved or listed, a sales ban shall be imposed. In the case of repeated violation, their business operations may be suspended.3. For those that manufacture, import, sell, or display with the intent to sell defective medical devices, in the case of a serious violation or repeated violation, the original approving authority may cancel all of their medical device licenses or listings and medical device manufacturing licenses, or may suspend their business operations.The competent authority may announce the name, address, and responsible person of firm or business subject to the disciplinary actions set forth in the preceding paragraph, name of medical devices, and circumstances of violation.