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Three kinds of medical technology clinical access approval is cancelled

2015.10.16   08:23

According to the notice,the ban on clinical application of medical technology are:the major problems of safety,effectiveness of medical technology,such as damage to the pituitary gland alcohol treatment of intractable pain;Major ethical issues,such as a surrogate technology;The family planning administrative department of public health's ban on clinical application of medical technology,such as body YanChangShu except medical purposes;The clinical medical technology was eliminated.Involves the use of drugs,medical devices and related products with similar attributes,such as preparation of medical technology,in medicine,medical apparatus and instruments or related products with similar properties,preparation and so on without the approval of the food and drug administration listed before,medical institutions may not engage in clinical application.

Notice is clear,for safety,efficacy precise,but the technology is difficult,high risk,the medical service ability and personnel organization level have higher requirements,need qualification;Or there are significant ethical risk,need strict management of medical technology,a medical institution shall limit the clinical application.Such as hematopoietic stem cells (including umbilical cord blood hematopoietic stem cell transplantation to treat diseases of the blood system technology,the proton and heavy ion accelerator radiation therapy technology,radioactive particles implantation treatment technology (including oral and maxillofacial malignant tumor radioactive particles implantation treatment technology),tumor deep heat treatment and heat treatment technology,tumor ablation technique,ventricular assist device application technology,cranial and maxillofacial deformities,craniofacial surgical correction of oral and maxillofacial tumors,skull and jaw joint radical technique of artificial intelligent auxiliary diagnosis,treatment,etc.;Same islet transplantation diabetes technology,allograft tissue for the treatment of technology (limited to the cornea,bone,cartilage,skin transplantation treatment technology),gender reset technology,etc.

By Alice

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