Regulations of Medicament Manufacturer Inspection 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.