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Chapter Law Content

Title: Medical Devices Act CH
Category: Ministry of Health and Welfare(衛生福利部)
Chapter V Management of Medical Device Advertisements
Article 40
Businesses other than medical device firms are not allowed to engage in advertising of medical devices.
Article 41
In the event that a medical device firm wishes to publish or broadcast a medical device advertisement, the license holder or the person who has completed the listing shall, before publishing or broadcasting, submit all texts, pictures, or speeches constituting the advertisement to the municipal competent authority if the medical device firm is located in a municipality, or to the central competent authority if it is located in a county (city), for approval.
During the approved period of publishing or broadcasting, no modification or alteration of the approved content of a medical device advertisement shall be allowed.
If the original approving authority finds that the content of an approved medical device advertisement or the way it is published or broadcast violates the provisions of the preceding paragraph or may cause harm to the health of human body, it shall order the medical device firm to immediately stop publishing or broadcasting the said advertisement or to make corrections within a time period. For those who fail to make corrections within the time period, their approval shall be cancelled.
The authority imposing the disciplinary action set forth in the preceding paragraph shall notify with a copy to the mass media enterprises publishing or broadcasting the advertisement of the action.
Article 42
No mass media enterprise shall publish or broadcast any medical device advertisement which has not been approved by the central or municipal competent authority, whose content is different from the approved content, which has been cancelled, or for which an order has been issued to immediately stop publishing or broadcasting or to make corrections within a time period but no corrections have been made.
A mass media enterprise that is commissioned to publish or broadcast an advertisement shall preserve the name, number of the identification document or business registration certificate, domicile, firm, or business office, telephone number, and other relevant information for six months following the last date of advertisement, and shall not evade, impede, or refuse any request by the competent authority for such information.
Article 43
The validity period for a medical device advertisement approval document shall be three years, starting from the date of issue. Where it is necessary to continue advertising upon expiration, an application for extension shall be filed with the original approving authority six months before the date of expiration. Each period of extension shall not exceed three years.
Article 44
In the event that the medical devices shall be used by medical personnel as stated in the instructions or announced by the central competent authority, the advertisements of such medical devices shall be published only in the medical publications, mass media, or related medical academic activities that are for the exclusive participation of medical personnel.
Article 45
Medical device advertisements shall not be made in the following manners:
1. To be publicized in the name of others.
2. To warrant the effectiveness or performance by making use of books and periodicals, documents, or data.
3. To be publicized by means of interviews or news reports.
4. To be publicized by any other improper means.
Article 46
Labeling or promotion of therapeutic effect for non-medical devices shall not be allowed. However, this shall not apply if it is otherwise provided in other laws.