CCC Scheme: Up-grade in HCE Standards

With reference to the CCC scheme, CQC published the deadline for up-grading relevant HCE from old to new standards. The up-grade requires new type testing.

The deadlines are defined as follows:

By 1 July 2013 the CCC certificates using old standards will be suspended; by this date the HCE enterprises should have initiated the up-grade process already.

By 1 October 2013 the CCC certificates referring to the old standards will be revoked; by this date any up-grade process must be completed.

Product in CCC Catalogue OLD Standard NEW Standard
Electrocardiographs GB9706.1-1995 GB9706.1-2007
Haemodialysis Equipment
Medical diagnostic X-ray equipment
Artificial Heart-lung Machine - Roller pump
Artificial Heart-lung Machine - Roller throb pump
Artificial Heart-lung Machine - Heat exchange water tank
Medical diagnostic X-ray equipment GB9706.15-1999 GB 9706.15-2008
Extracorporeal blood circuit for blood purification equipment YY0267-1995 YY0267-2008
Hollow fiber dialyser YY0053-91 YY0053-2008

For more comments on the new standard GB9706.1-2007 please refer to pag.2 of QP flyer on Approval for Medical Devices.

It is advisable that interested HCE enterprises start the process immediately.

CQC link (Chinese):