B blah01 Involved In Discussions Jul 27, 2017 #1 Jul 27, 2017 #1 Does anyone know if ISO 15254:2009 is an actual requirement to enter the China market for ophthalmic products? If so, which actual regulatory requirements is it addressing? Thanks.
Does anyone know if ISO 15254:2009 is an actual requirement to enter the China market for ophthalmic products? If so, which actual regulatory requirements is it addressing? Thanks.
Ajit Basrur Staff member Admin Sep 11, 2017 #2 Sep 11, 2017 #2 Did not see in the IMDRF list of recognized standards for China; however it is contained in the "RS-01, List of Recognised Standards for Medical Devices". . Attachments IMDRF List of Recognised Standards for China.pdf 528.7 KB Views: 272 RS_01_20150610.pdf 812.4 KB Views: 153
Did not see in the IMDRF list of recognized standards for China; however it is contained in the "RS-01, List of Recognised Standards for Medical Devices". .