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Removing the need for duplicative testing of medical devices


China has mandated (in-country) electro-magnetic compatibility testing for Class II and III medical devices. As the Chinese testing standard is identical to IEC 60601-1-2 (2004), China is able to accept test reports from overseas laboratories accredited by accreditation bodies that are members of ILAC (i.e. signatories to the ILAC MRA), as an alternative to in-country testing by a Chinese laboratory.