Something You Must Know on GMP & GSP Implementation in China

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 respectively.

On Sep 5^th, 2014, CFDA issued the Announcement (No. 15-2014) on medical devices GMP to promote its implementation based on the < Regulations for the Supervision and Administration of Medical Devices – State Council Decree No. 650> and the < Administrative Measures for the Supervision of Medical Device Manufacturing - CFDA Decree No. 7>. On Dec 12^th, 2014, CFDA released the 58^th Announcement on the implementation of GSP.

According to the Announcement, 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. The more information about the GMP & GSP implementation in China can be found as follows.

Type	For Which MDs are Concerned	Implementation Date
GSP	all medical devices distributing	Dec 12^th, 2014
GMP	sterile and implantable medical devices manufacturing	Jan 1^st, 2011
	new establishment or update of manufacturing license for class Ⅲ medical devices	Oct 1^st, 2014
	class Ⅲ medical devices manufacturing	Jan 1^st, 2016
	all medical devices manufacturing	Jan 1^st, 2018

Reference:

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Ms. Elaine Lyu Elaine@cirs-group.com

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