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.
GMP and GSP implementation timelines
|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.
Mr. Edwin Wen China office
Tel: +86 571 8720 6541 | Fax: +86 571 8720 6533
Mr. Michael Petersen China office
Tel: +86-571 8720 6559 | Fax: +86-571 8720 6533
Mr. Junho Lee
Tel: +82 2 6347 8801