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National Health Commission Issues Document! New Opportunities for These Medical Devices: Ultrasound, Testing...
Release time:
2025-03-12 09:42
On January 3, the National Health Commission issued the "Notice on Issuing the Basic Standards for Medical Institutions Conducting Prenatal Screening and Prenatal Diagnosis," outlining specific requirements for institutions conducting prenatal screening and diagnosis. This will bring new opportunities to the ultrasound, testing, biochemical analysis, and telemedicine equipment markets.
Regarding the requirements for establishing institutions conducting prenatal screening, the standards stipulate that they must have obstetrics and gynecology, ultrasound, and laboratory departments, as well as a medical ethics committee. They must possess the professional capabilities to conduct clinical consultations, midwifery services, and ultrasound prenatal screening, and be able to independently conduct biochemical and immunological laboratory tests, or collaborate with prenatal diagnosis institutions to conduct such tests and fetal free DNA prenatal screening and diagnosis-related blood collection services for pregnant women.Regarding the requirements for establishing institutions conducting prenatal diagnosis, the standards stipulate that they must have obstetrics and gynecology, pediatrics, medical imaging (ultrasound), laboratory, and pathology departments, an independent genetic counseling clinic, and a medical ethics committee; they must be capable of independently conducting genetic counseling (including genetic disease counseling and prenatal counseling), medical imaging (ultrasound), biochemical immunology, cytogenetics, and fetal pathology services. They can independently conduct molecular genetics or, in accordance with relevant requirements, collaborate with capable medical institutions to provide related services. Capable prenatal diagnosis institutions are encouraged to independently conduct molecular genetics projects.
Specifically regarding equipment configuration, medical institutions conducting prenatal screening should have equipment suitable for prenatal screening work (see Appendix 1), and ultrasound prenatal screening rooms should be equipped with ultrasound instruments and image management and storage systems necessary for the work.“The ultrasound instruments and image management and storage systems should be equipped to support the work.“establish a remote consultation system”.
Appendix1 Basic Equipment Requirements for Prenatal Screening Institutions
|
Equipment Name |
Basic Quantity |
|
Ultrasound Prenatal Screening Room |
|
|
Color Doppler Ultrasound Diagnostic Instrument |
1 |
|
Ultrasound Workstation (Image Management and Storage System) |
1 |
|
Biochemical Immunology Laboratory |
|
|
Ordinary Centrifuge |
1 |
|
Fully Automated Biochemical Immunology Analyzer |
1 |
|
Ordinary Refrigerator |
2 |
|
-80℃ Freezer |
1 |
|
Other |
|
|
Computer (with internet access) |
2 |
|
File Cabinet |
2 |
Appendix2 Basic Equipment Requirements for Prenatal Diagnosis Institutions
|
Equipment Name |
Basic Quantity |
|
Ultrasound Prenatal Diagnosis Room |
|
|
Ultrasound Instrument with Puncture Guidance Device |
1 |
|
Color Doppler Ultrasound Diagnostic Instrument |
2 |
|
Ultrasound Workstation (Image Management and Storage System) |
2 |
|
Cytogenetics Laboratory |
|
|
Ordinary Binocular Microscope |
2 |
|
Trinocular Research Microscope with Microphotography Equipment |
1 |
|
Inverted Microscope with Microphotography Equipment |
1 |
|
Fluorescence Microscope |
1 |
|
Clean Bench or Biological Safety Cabinet |
1 |
|
CO2 Incubator |
2 |
|
Ordinary Centrifuge |
2 |
|
Constant Temperature Drying Oven |
1 |
|
Ultrapure Water Instrument or Automatic Pure Water Distiller |
1 |
|
Constant Temperature Water Bath |
2 |
|
Ordinary Refrigerator |
2 |
|
Analytical Balance |
1 |
|
Ordinary Balance |
1 |
|
Biochemical Immunology Laboratory |
|
|
Ordinary Centrifuge |
1 |
|
Fully Automated Biochemical Immunology Analyzer |
1 |
|
Ordinary Refrigerator |
2 |
|
-80℃ Freezer |
1 |
|
Molecular Genetics Laboratory |
|
|
PCR Instrument |
2 |
|
Gel Imaging System |
1 |
|
Ordinary Centrifuge |
1 |
|
Tabletop High-Speed Centrifuge |
1 |
|
Electrophoresis Instrument |
1 |
|
Analytical Balance |
1 |
|
Constant Temperature Incubator |
1 |
|
UV Spectrophotometer or Nucleic Acid Protein Detector |
1 |
|
Biological Safety Cabinet |
1 |
|
Micropipette (different specifications) |
2 (sets) |
|
Ordinary Refrigerator |
2 |
|
-20℃ Refrigerator |
1 |
|
-80℃ Freezer |
1 |
|
Prenatal Diagnosis Daily Management Workplace |
|
|
Computer (with internet access) |
2 |
|
File Cabinet |
2 |
Equipment, implementation, ultrasound, antenatal, general, antenatal diagnosis, medical institution, biochemical, basic
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