Regulation for Registration of Medical Devices Article 7

The manufacture and free sale certificates of the country of origin referred to in this Regulation are verifying documents issued by the highest health authority of the country where the imported medical device is manufactured. The content of such documents shall state the name and the address of the manufacturing factory, the name of the medical device, the specifications and model of the medical device, the circumstances of manufacture, and the certification of approval for domestic sale in that country. If it is confirmed that the medical device is not regulated by the highest health authority in the country of the manufacturer, said manufacturing and sales approval documents may be issued by the local health agency or an organization approved by Taiwan's central health competent authority.With regard to the manufacture and free sale certificates in the foregoing Paragraph, if an imported medical device is commissioned to manufacture, and the device is not on sale in the country of the commissioned manufacturing factory, a free sale certificate issued from the country’s highest competent health authority of the commissioning company and a manufacture certificate issued from the country’s competent authority of commissioned manufacturing factory may be submitted instead of the foregoing manufacture and free sale certificate.If an imported medical device is commissioned to be manufactured, the manufacture and free sale certificates in Paragraph 1 are allowed to be issued by respective highest health competent authority of the country either of the commissioning company or of the commissioned manufacturing factory.The manufacture and free sale certificates in Paragraph 1 is allowed to be substituted by a certificate of manufacture issued by the government of the country where the imported medical device is manufactured and a certificate of free sale issued by the highest health competent authority of the United States of America, or any member state of the European Union.The verifying documents in the four preceding paragraphs shall remain valid for two years after the date of issuance, and shall be notarized by Taiwan's embassy or consulate, representative office, other official office, or overseas organization in that country authorized by the Ministry of Foreign Affairs (hereafter referred to as the overseas representative organization of Taiwan). A Chinese or English translation shall be attached when the verifying documents are not in English, and the translation shall also be notarized.