Medical Devices Act Article 65

Any person violating the provisions of Article 46 and labeling or promoting non-medical devices as having therapeutic effects shall be subject to a fine of not less than NT$600,000 but not more than NT$25,000,000.A fine of not less than NT$200,000 but not more than NT$5,000,000 shall be imposed when any of the following circumstances occurs:1. Violating the provisions of Article 40 and engaging in advertising of medical devices without being a medical device firm.2. Violating the provisions of Paragraph 1 of Article 41 and failing to apply for approval or forward approval documents to mass media enterprises for verification before publishing or broadcasting a medical device advertisement.3. Violating the provisions of Paragraph 2 of Article 41 and modifying or altering the originally approved contents of a medical device advertisement without approval.4. Violating the restrictions on the extent of publishing or broadcasting medical device advertisements specified in Article 44.5. Where medical devices are advertised in any of the manners set forth in the provisions of Article 45.6. Where a medical device firm fails to give a notice or recall medical devices within the specified time period under any of the circumstances set forth in Subparagraphs 1 through 3 of Paragraph 1 of Article 58.