Quality Assurance & Compliance

Medical devices manufacturer and distributor must establish and follow the medical device quality management system, the quality management system are known as Good Manufacturing Practices (GMP) for manufacturer and Good Supplier Practices (GSP) for distributor.

China has implemented the GMP on sterile and implantable medical devices from Jan, 1st 2011 and it will be expanded to all medical devices manufacturing until Jan. 1st 2018 according to CFDA notice No.15-2014. The more information about the GMP implementation in China can be found here.

On Dec, 12th 2014, CFDA released the 58th Announcement on the implementation of GSP. It indicated that all distributors were required to establish the quality management system corresponding to the GSP to ensure the quality safety in the process of procurement, inspection, storage, transportation, sale, after-sale service.

GMP and GSP implementation timelines

Type Implementation date
GSP All medical device distributing

Dec, 12th 2014

GMP Sterile and implantable medical devices manufacturing Jan, 1st  2011
New establishment or update of manufacturing license for class III medical devices Oct. 1st 2014
Class III medical devices manufacturing Jan, 1st 2016
All medical devices manufacturing Jan, 1st 2018

How to comply with the quality management regulations in China?

Quality management 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.

If you would like to have a local QM responsible person to deal with the regulatory compliance and quality management, please feel free to contact us. 

Please join in our “China Medical Device Regulatory Assistant Program” for free proposal. For complex and urgent projects, we will assign a dedicated project manager to customize a program specific to your requirements. We are ready to be of service at any time.

Contact Us

Mr. Edwin Wen China office
Tel: +86 571 8720 6541 | Fax: +86 571 8720 6533
Email: Edwin.wen@cirs-group.com
Mr. Michael Petersen China office
Tel: +86-571 8720 6559 | Fax: +86-571 8720 6533
Email: Elaine@cirs-group.com


 

Contact Us
CIRS China

Ms. Elaine (Head office)
Tel: +86-571 87206559 | Fax: +86-571 87206533
Email: md@cirs-group.com
Mrs.Emily (Beijing office)
Tel: +86-10 63984062 | Fax: +86-10 63984032
Email: md@cirs-group.com

CIRS Europe

Ms. Louise Halpin
Tel: +353 41 9806 916 | Fax: +353 41 9806 999
Email: md@cirs-group.com