These medical device product standards and methodological standards to become higher
January 30 News January 29, State Administration of Drug Administration issued a public medical device standard planning (2018-2020).
According to the document, in the next three years, our country will revisit it medical instruments 300 standards, focusing on promoting the following standards in these areas of medical device products and methods to improve standards:
First, the medical device quality management standardization focus areas
Medical device quality management, medical device risk management, medical device clinical trial management.
Second, active medical equipment standardization key areas
(I) Promote the transformation of international standards for general and specialized safety of medical electrical equipment, formulate common basic standards and supporting implementation plans and teaching materials.
(B) medical robots, active implants, medical software, PET-MRI and other multi-technology integration of medical devices, medical respiration and anesthesia equipment, medical equipment disinfection Sterilization field, the field of oral digital equipment, medical devices, radiotherapy and nuclear medicine equipment, medical ultrasound equipment, physical therapy, medical laboratory equipment, medical X-ray diagnostic equipment, medical laser equipment.
Third, passive medical equipment standard Focus areas
(1) Promote the translation of international standards for the evaluation of medical device biology to further improve the standard system for general and specialized methods of biological evaluation.
(B) the field of new surgical instruments, new types of infusion apparatus, family planning instruments, assisted reproductive equipment, new medical joints, new sanitary materials and dressings, additive manufacturing, oral digital material quality evaluation, tissue engineering , Nano-medical devices, allogeneic materials, resorbable implants, new biomaterials and their products, contact lens care products and intraocular fillings.
Fourth, in vitro diagnostic medical equipment standardization focus areas
Traceability and reference measurement systems, high-throughput sequencing and other new molecular diagnostic techniques, mass spectrometry in the field of clinical in vitro diagnostic applications, infectious diseases in vitro diagnostic reagents, POCT field.
