Quality management and Compliance for medical device

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

On Dec, 12^th 2014, CFDA released the 58^th 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.

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