China Association for Medical Devices Industry (CAMDI) - Purchase of Guide for Good Manufacturing Practice for Medical Devices (two volumes in total) Written by NMPA

Guide for Good Manufacturing Practice for Medical Devices (two volumes in total) composed by the Department of Medical Device Supervision and Center for Drug Evaluation, National Medical Products Administration (NMPA) is recommended by China Association for Medical Devices Industry (CAMDI) to the whole medical device industry. This recommendation is intended to better enforce the Good Manufacturing Practice for Medical Devices, and help inspectors and supervisors of medical devices, as well as employees of relevant enterprises better understand the regulatory requirements, as a means to deliver inspection efforts of China’s quality management system for medical devices and upgrade the capability of inspection teams for medical devices.

Combining supervision efforts on medical devices in China over many years and drawing on the advanced experience of foreign countries, this guide is aimed at the actual needs in inspecting and supervising medical devices. It details specific requirements, focuses of inspection, inspection methods techniques, as well as common problems and analysis of typical cases in the good manufacturing practice for medical devices. The Guide for Good Manufacturing Practice for Medical Devices (Volume 1) is completed based on the general requirements for the quality management system of all medical device manufacturing enterprises under the Good Manufacturing Practice for Medical Devices. The Guide for Good Manufacturing Practice for Medical Devices (Volume 2) is designed to guide and assist supervisors of medical devices and medical device manufacturers to better understand and grasp the relevant requirements set out in the appendix of Good Manufacturing Practice for Medical Devices. On the basis of Volume 1, it gives an detailed account of the traits and special requirements of sterile medical devices, implantable medical devices, and in vitro diagnostic reagent products.
Introduction:

Volume 1 elaborates on content of chapters, overview, guide for inspection articles, notes, common problems, and case studies. The overview offers a detailed interpretation of the content of the chapter, including its purpose and principles, background, basic content and difficulties, the application scope etc. The guide for inspection articles includes interpretation of the terms, focuses of inspection, inspection methods and techniques, etc. The notes are descriptions of the content on which attentions should be place. Common problems and case studies is aimed at helping inspectors better understand the article by analyzing typical cases in inspection.

On the basis of Volume 1, Volume 2 gives a detailed account of the traits and special requirements of sterile medical devices, implantable medical devices, and in vitro diagnostic reagent products. In particular, it also includes the basic knowledge, process characteristics, and focuses of risks and control of these three types of products, with a view to helping readers better understand such products and grasp the requirements of on-site inspection.
For questions regarding subscription or purchase, please contact:
Innovation Services Committee, China Association for Medical Devices Industry
Contact: Huang Sisi; Tel: 17610605726; Email:sisihuang_work@163.com

Purchase of Guide for Good Manufacturing Practice for Medical Devices (two volumes in total) Written by NMPA

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