Regulations of Medicament Manufacturer Inspection｜第 7 條｜Food and Drug Administration｜Regulation｜In Force
衛生福利部｜v1.0
Last Amended: 2014-02-21
For foreign manufacturers of imported medical devices mentioned in Subparagraph 1, Paragraph 1 of Article 3, the Taiwan agents (pharmaceutical companies) shall apply for inspection by submitting a fee, along with two completed application forms and the following documents to the central competent health authority: (1) Documents of the quality system of the foreign manufacturer of imported medical device; (2) Certificate of compliance equivalent to medical device GMP certification; (3) Plant layout diagram, as well as information on product production areas, major equipment, and manufacturing processes from the foreign manufacturer of the imported medical device; where necessary, information on production personnel and transportation channels may be required for the application process. For the documents of quality system mentioned in Subparagraph 1 of the preceding Paragraph, the applicant may first submit a quality manual, documents of relevant procedures, and document master list. When necessary, the applicant must submit additional quality system documents or information as per the instructions of the central competent health authority. If the country of origin of the manufacture is the United States, the applicant may submit a manufacturing and sales approval certificate from the highest competent health authority of the U.S., clearly stating that the manufacturer is in compliance with the US Pharmaceutical Current Good Manufacturing Practices (e.g. ISO 13485 Certificate), in place of the documents mentioned in Subparagraph 2 of Paragraph 1. If the country of origin of the manufacture is the United States, Puerto Rico or Guam, as long as the Taiwan-U.S. medical device technical cooperation and document exchange program is valid, the applicant may submit an audit report and manufacturing and sales approval certificates issued by the highest competent health authority of the U.S., along with a certificate of compliance equivalent to a medical device GMP certificate (e.g. ISO 13485 Certificate), in place of the documents mentioned in Subparagraph 1 through Subparagraph 3 of Paragraph 1. If the country of origin of the manufacture is an EU member state, Switzerland, or Liechtenstein, as long as the Taiwan-EU, Taiwan-Swiss, or Taiwan-Liechtenstein medical device technical cooperation and document exchange program is valid, the applicant may submit an audit report issued by an EU medical device notified body that has received cooperation approval documents from the central competent health authority and is party to the audit report exchange technical cooperation agreement with medical device GMP notified bodies designated by the central competent health authority, along with manufacturing and sales approval certificates from the highest competent health authority in said country, and a certificate of compliance equivalent to a medical device GMP certificate (e.g. ISO 13485 Certificate) from the relevant medical device notified body that has received cooperation approval documents, in place of the documents mentioned in Subparagraph 1 through Subparagraph 3 of Paragraph 1. If inspection of the foreign factory is required as part of the inspection mentioned in Paragraph 1, the applicant shall submit a fee, along with the foreign manufacturer’s quality manual, to the central competent health authority, and coordinate with the foreign manufacturer in preparing the information required for the inspection process.