医疗器械法规和管理-CittàdellaScienza.pptVIP

Standardized technical committee number name secretariat 1 TC 136 IVD BIMT 2 TC 10/SC1 X ray equipment Liaoning 3 TC 10/SC3 Radiotherapy nuclear BIMT 4 TC 10/SC2 Ultrasound equipment Hubei 5 TC 10 /SC4 Physical therapy Tianjin 6 TC 10/SC5 Electrical medical device shanghai 7 TC 94 Surgery device shanghai 8 …… …… …… There are 22 standardized technical committees being response for drafting and revising national and industrial standards * * RPS － MD Should have RPS including national standards and industrial standards，but requirements of RPS shall not be lower than requirements of national