Regulations of Medicament Manufacturer Inspection｜第 6 條｜Food and Drug Administration｜Regulation｜In Force
衛生福利部｜v1.0
Last Amended: 2014-02-21
Domestic medical device manufacturers of the new establishment, relocation, expansion, resumption of operations, or addition of medical device products, 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) Quality manual; (2) A certificate of factory registration; (3) Permit license of pharmaceutical manufacturer.