On a class of medical devices to submit electromagnetic compatibility test report matters

According to the requirements of the State Food and Drug Administration "Notice on the Implementation of YY0505-2012 Medical Device Industry Standards" (Food and Drug Administration Office of Equipment (2012) No. 151), since January 1, 2014, for the first time the registration of the third class of medical electrical equipment, enterprises in the registration declaration should be submitted by the medical device testing organization issued by the test report to meet the requirements of the electromagnetic compatibility standards. Electromagnetic compatibility standard requirements of the test report.

For the January 1, 2014 has been accepted for registration and has been registered in the third category of medical electrical equipment, enterprises in the application for re-registration should be submitted to meet the requirements of the electromagnetic compatibility standards of the corresponding test report.

Since the implementation of the electromagnetic compatibility standards for one year, for the first time the second class of registered medical electrical equipment, enterprises in the registration declaration should be submitted by the medical device testing organizations to meet the requirements of the electromagnetic compatibility standards test report. For the first registration of the first class of medical electrical equipment, enterprises in the registration declaration should be submitted to include the EMC standard requirements of the full performance test report.

For this has been accepted for registration and has been registered in the first and second class of medical electrical equipment, enterprises in the re-registration should be submitted to meet the requirements of the electromagnetic compatibility standards of the corresponding test report.