In the next three years, my country will re-enact and revise 300 medical device standards, focusing on promoting the improvement of medical device product standards and method standards in the following areas:

1. Key areas of medical device quality management standardization

Medical device quality management field, medical device risk management field, medical device clinical trial management field.

2. Key areas of active medical device standardization

(1) Promote the transformation of general and special safety international standards for medical electrical equipment, formulate general basic standards and supporting implementation plans and teaching materials.

(2) The field of medical robots, active implants, medical software, PET-MRI and other multi-technology fusion medical equipment fields, medical breathing and anesthesia equipment fields, medical equipment disinfection and sterilization fields, oral digital equipment fields, medical bodies Medical equipment field, radiotherapy and nuclear medicine equipment field, medical ultrasound equipment, physical therapy field, medical laboratory equipment field, medical X-ray diagnostic equipment field, medical laser equipment field.

3. Key areas of passive medical device standardization

(1) Promote the transformation of international standards for the biological evaluation of medical devices, and further improve the standard system for general and special biological evaluation methods.

(2) The field of new surgical instruments, new infusion devices, family planning devices, assisted reproductive devices, new medical joints, new sanitary materials and dressings, additive manufacturing, oral digital material quality evaluation, and tissue engineering , Nano medical device field, allogeneic material field, absorbable implant device field, new biological material and its product field, contact lens care product field, intraocular filler field.

4. Key areas of in vitro diagnostic medical device standardization

Traceability and reference measurement systems, high-throughput sequencing and other new molecular diagnostic technologies, mass spectrometry technology in clinical laboratory in vitro diagnostic applications, infectious diseases in vitro diagnostic reagents, and POCT.