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NMPA Issued Guidelines for Technical Review of the Registration of Custom-Made and Material AdditiveBased Medical Devices of Passive Implantable Bones, Joints and Oral Hard Tissues

CCFDIE|Updated: 2019-10-15

To strengthen the supervision and guidance over the registration of medical device products and further improve the quality of registration examination, NMPA has organized the formulation of and released on May 15, 2019 the Guidelines for Technical Review of the Registration of CustomMade and Material Additive-Based Medical Devices of Passive Implantable Bones, Joints and Oral Hard Tissues.