Is ISO 15254:2009 a requirement for China for ophthalmic products market?

[blah01]

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]

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".
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