Quality management and Compliance for medical device
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.