Article 3
Inspections of medicament manufacturers shall be categorized as following:
(1) Inspections of the new establishment, relocation, expansion, resumption of operations, or addition of new active pharmaceutical ingredients, dosage forms, processes (packaging and labeling), products;
(2) Inspections of the follow-up management of medicament manufacturers;
(3) Regional routine inspections;
(4) Other types of inspections.
Domestic medicament manufacturers mentioned in Subparagraph 1 of the preceding Paragraph, their hardware facilities and sanitary conditions must comply with regulations of Part 2 of the Standards for Medicament Factory Establishments and the Factory Management Guidance Act, and shall be subject to inspection by the competent industry authorities and municipal or county (city) competent health authorities; their software facilities and sanitary conditions must comply with regulations of the Pharmaceutical Good Manufacturing Practice, and shall be subject to inspection by the central competent health authority in accordance with regulations of Article 4 or Article 6.
Foreign medicament manufacturers mentioned in Subparagraph 1 of Paragraph 1 must comply with regulations of the Pharmaceutical Good Manufacturing Practice, and shall be subject to inspection by the central competent health authority in accordance with regulations of Article 5 or Article 7.
For inspections mentioned in Subparagraph 2 of Paragraph 1, domestic medicament manufacturers shall be inspected in accordance with regulations of Article 8, and foreign medicament manufacturers shall be inspected in accordance with regulations of Article 9.
Firms approved by the central competent health authority to manufacture medicaments for development, if applications for marketing of their products are not made, regulations of the three preceding Paragraphs may not apply. However, their medicaments for clinical trials shall comply with regulations of the Pharmaceutical Good Manufacturing Practice, and shall be subject to inspection by the competent health authorities.
Inspections mentioned in Subparagraph 3 of Paragraph 1 shall be conducted in accordance with regulations of Article 11.
Inspections mentioned in Subparagraph 4 of Paragraph 1 shall be conducted in accordance with regulations of Article 12.

Article 7
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.

Article 8
The inspections of domestic pharmaceutical manufacturers mentioned in Subparagraph 2, Paragraph 1 of Article 3 shall be conducted every two years and may extend one to two years depending on the types of dosage forms manufactured, process activities and inspection history. Domestic medical device manufacturers shall be inspected every three years.
Manufacturers must apply for inspections mentioned in the preceding Paragraph six months prior to the expiration of their medicament manufacturing license.
When the central competent health authority deems it necessary, or finds that a medicament poses a major hazard, additional for-cause inspections may be conducted without prior notification of the inspected party.
Of the inspections mentioned in Paragraph 1 and 3, the central competent health authority inspects the current status of pharmaceutical GMP or medical device GMP implementation by manufacturers; it may notify the municipal or county (city) competent health authorities and the competent industry authorities to participate in the inspection. Manufacturers shall cooperate with the inspection in accordance with regulations of Article 4 or Article 6.

Article 9
The follow-up inspections of foreign pharmaceutical manufacturers of imported drugs shall be conducted every two years and may extend one to two years depending on the management system and standards for pharmaceutical manufacturing in country of origin; in addition to document review, on-site inspections shall be conducted depending on types of dosage forms of imported products, process activities, inspection history and the management system and standards for pharmaceutical manufacturing in country of origin. The foreign medical device manufacturers of imported medical device shall be inspected every three years.
Manufacturers must apply for inspections mentioned in the preceding Paragraph six months prior to the expiration of their approval documents.
When the central competent health authority deems it necessary, or finds that a medicament poses a major hazard, additional for-cause inspections may be conducted.
Of the inspections mentioned in Paragraph 1 and 3, the central competent health authority inspects the current status of pharmaceutical GMP or medical device GMP implementation by manufacturers. Manufacturers shall cooperate with the inspection in accordance with regulations of Article 5 or Article 7.

Article 10
Domestic medicament manufacturers in compliance with regulations of Article 4,Article 6, and Article 8 will be issued with medicament manufacturing licenses by the central health authority.
Foreign medicament manufacturers in compliance with regulations of Article 5,Article 7, and Article 9 will be issued with approval documents by the central health authority.