Pharmaceutical Good Manufacturing Practice Regulations Article 94
Manufacturers shall perform design and development validation in accordance with planned arrangements, and complete it prior to the delivery or implementation of the product to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use.Records of the results of validation and any necessary actions shall be maintained.Manufacturers shall perform clinical evaluation and evaluation of performance of the medical device in accordance with the regulatory requirements of central competent health authority.
中文原文 藥物優良製造準則第94條
製造業者應依據所規劃之安排對設計與開發在產品交運或實施之前完成確認，以確保最終產品能符合特定之應用或預期使用要求。
確認結果及任何必要措施之紀錄應予以維持。
製造業者應依據中央衛生主管機關及相關法規要求，實施醫療器材臨床評估及性能評估。
確認結果及任何必要措施之紀錄應予以維持。
製造業者應依據中央衛生主管機關及相關法規要求，實施醫療器材臨床評估及性能評估。