NMPA under Pandemic: Record Number of Guidelines and Standards Issued in March

Despite the global outbreak of novel coronavirus (COVID-19), NMPA published 16 guidelines and 43 standards in March, guiding manufacturers with type testing and registration.

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Generic Guideline

Principle of Safety and Efficacy of Medical Device

Specific Guideline

• Plastic Surgery

Registration guideline for semiconductor laser hair removal machine

• Cardiovascular

Registration guideline for implantable left ventricular assist system

• Imaging

Registration guideline for X-ray image guidance systems for radiotherapy

Registration guideline for positron emission / X-ray computed tomography system

• IVD reagent

Registration guideline for EB virus nucleic acid detection reagent

Registration guideline for Hepatitis B virus e antigen and e antibody detection reagents

Registration guideline for Thalassaemia related gene detection reagents

Registration guideline for Hepatitis B virus resistance related gene mutation detection reagent

Registration Guideline on Colloidal Gold Immunochromatographic Analyzer

Registration Guideline on Human Follicle Stimulating Hormone (FSH) Detection Reagent

Registration Guideline on Creatinine Assay Reagent

Registration Guideline on Antinuclear Antibody Detection Reagent

Reagent Guideline on Antithyroid Peroxidase Antibody Assay

Registration Guideline on Glycated Albumin Assay Reagent

Registration Guideline on Total Bile Acids Reagent

Standard

1. YY 0167-2020 non-absorbable surgical suture
2. YY 1116-2020 absorbable surgical suture
3. YY / T 0573.4-2020 Disposable sterile syringes Part 4: Preventing reuse of syringes
4. YY / T 0823-2020 Dental Science Fluoride anti-caries material
5. YY / T 1693-2020 dentistry maxillary sinus membrane lifter
6. YY / T 1710-2020 disposable abdominal puncture device
7. YY / T 1720-2020 Combined acetabular component separation force test method
8. YY 0104-2018 Triangular needle
9. YY 0838-2011 microwave thermal coagulation equipment
10. YY 0852-2011 Disposable sterile surgical membrane
11. YY / T 0061-2007 Specific electromagnetic wave treatment device
12. YY / T 0148-2006 General requirements for medical tape
13. YY / T 0931-2014 Medical endoscope Endoscope equipment Coil ligature device
14. YY / T 0086-2020 Medical refrigerator
15. YY / T 0513.3-2020 Allogeneic repair materials Part 3: Demineralized bone
16. YY / T 0595-2020 Medical Device Quality Management System YY / T 0287-2017 Application Guide
17. YY / T 0734.5-2020 washer-disinfector part 5: washer-disinfector for chemical disinfection of non-intrusive medical devices that are not resistant to high temperature requirements and tests
18. YY / T 0809.13-2020 Surgical implants Part and total hip prosthesis Part 13: Determination of the torsional moment of the head fixation of the femoral component with handle
19. YY / T 1182-2020 Reagents for nucleic acid amplification detection (box)
20. YY / T 1653-2020 pipeline for infusion pump
21. YY / T 1680-2020 Allogeneic repair materials Evaluation of in vivo osteogenic performance of demineralized bone materials
22. YY / T 1685-2020 pneumatic pulse oscillation sputum discharge equipment
23. YY / T 1686-2020 classification of medical electrical equipment using robot technology
24. YY / T 1690-2020 Determination of 2-chloroethanol residue in disposable PVC infusion devices
25. YY / T 1691-2020 dentistry mobile phone torque transmitter
26. YY / T 1692-2020 dentistry hot melt dental glue filling machine
27. YY / T 1694-2020 body surface optical positioning equipment for radiotherapy performance and test methods
28. YY / T 1697-2020 Synthetic water activated polyurethane glass fiber orthopedic bandage strength and curing time test method
29. YY / T 1699-2020 tissue engineering medical device products chitosan
30. YY / T 1702-2020 Dentistry Additive manufacturing Laser selection melting metal materials for oral fixation and mobile restoration
31. YY / T 1703-2020 dentistry orthodontic coil spring
32. YY / T 1704.1-2020 Single-use cervical dilator Part 1: Progressive
33. YY / T 1704.2-2020 Single-use cervical dilator Part 2: Inflatable
34. YY / T 1705-2020 Surgical implants Hip prosthesis ceramic femoral head impact resistance measurement method
35. YY / T 1706.1-2020 Surgical implants Metal surgical implants Plasma sprayed pure titanium coating Part 1: General requirements
36. YY / T 1707-2020 Surgical implants Differential scanning calorimetry of polyetheretherketone polymers and their composites for implantation of medical devices
37. YY / T 1707-2020 Surgical implants Differential scanning calorimetry of polyetheretherketone polymers and their composites for implantation of medical devices
38. YY / T 0292.1-2020 Medical diagnostic X-ray radiation protection equipment Part 1: Determination of material attenuation performance
39. YY / T 0292.2—2020 Medical diagnostic X-ray radiation protective equipment Part 2: Transparent protective plate
40. YY 0450.1-2020 Disposable sterile intravascular catheter accessories Part 1: Guiding instruments
41. YY / T 0621.2-2020 Dental Science Match Test Part 2: Ceramic-Ceramic System
42. YY / T 1656-2020 Morphine detection kit (colloidal gold method)
43. YY / T 1671-2020 ultrasound probe puncture frame