China Medical Device GxP Quality Systems

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

医疗器械生产质量管理规范

GCP

The Quality Management Practices for Medical Device Clinical Trial

医疗器械临床试验质量管理规范

GDP or GSP

The Quality Management Practices for Medical Device Distributing

医疗器械经营质量管理规范

GUP

The Quality Management Practices for Medical Device Use

医疗器械使用质量管理规范

GLP

Unimplemented

How GxP Quality System is Works

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.

Contact Us
CIRS China

Mr. Harold Xie (Head office)
Tel: +86-571 8720 6559 | Fax: +86-571 87206533
Email: md@cirs-group.com
Mr. Edwin Wen (Beijing office)
Tel: +86-10 63984062 | Fax: +86-10 63984032
Email: md@cirs-group.com

CIRS Europe

Bryan Zhou
Tel:  +353 (1)477 3710

Email: md@cirs-group.com

CIRS Korea
Mr. Junho Lee 
Tel: +82 2 6347 8801 
Email: md@cirs-group.com