Regulations of Medicament Manufacturer Inspection Article 15-1
Pharmaceutical companies that apply for manufacturing medical devices shall comply with medical device GMP regulations. If the inspection is determined non-compliance, pharmaceutical companies may apply for re-inspection in 2 month from the date of determination. The re-inspection is for once only.
中文原文 藥物製造業者檢查辦法第15-1條
藥商申請醫療器材製造業者應符合醫療器材優良製造規範之規定；經檢查不合格者，得於核定之日起二個月內提出複評，以一次為限。