China Medical Device GxP Quality Systems - Regulatory News - Medical Devices

GxP systems are quality management system (QMS) to ensure the safety and effectiveness during the lifecycle of medical product. China has adopted the medical device GxP quality systems these years, it is important to integrate regulatory, market, customer requirements in complying with GxP quality systems in China.

GxP Quality Systems

GxP
GMP	The Quality Management Practices for Medical Device Manufacturing 醫療器械生產質量管理規范
GCP	The Quality Management Practices for Medical Device Clinical Trial 醫療器械臨床試驗質量管理規范
GDP or GSP	The Quality Management Practices for Medical Device Distributing 醫療器械經營質量管理規范
GUP	The Quality Management Practices for Medical Device Use 醫療器械使用質量管理規范
GLP	Unimplemented

How GxP Quality System is Works

How to Comply with Medical Device GxP Quality Systems

GxP Quality systems shall involve in the full product lifecycle. Companies need to know what obligations or regulations to fulfill firstly, then to establish your own appropriate quality management system and follow it.

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