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News Update - 0322~0328

发布时间:2026-04-01阅读量:2来源:

Department

Update

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NMPA

Notice from the Comprehensive Department of the National Medical Products Administration on Carrying out the "Spring Rain Action" for the Transformation of Clinical Innovation Achievements of Medical Devices

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CMDE

Priority Announcement

- Hemodialysis apparatus

- Suzhou Zhuo Yi Medical Devices Co., Ltd.

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CMDE

Technical Review Criteria:

1. Implantable neural stimulation electrode

2. Neural regulation programmable charging device

3. Mobile magnetic resonance imaging system

4. Infusion pump with target-controlled infusion function

5. Temporary cardiac pacing electrode lead

6. True ear tester

7. Intravascular shock wave treatment equipment

8. Additive manufacturing polyetheretherketone bioceramic composite material cranial repair prosthesis system

9. Additive manufacturing absorbable composite bone repair material

10. Additive manufacturing bioceramic bone filling material

11. Absorbable surgical sutures (with triclosan coating)

12. Medical sealing adhesive

13. One-time use blood perfusion device

14. Research data related to biotin interference

15. Non-clinical study of hepatitis B virus pre-S2 antigen detection kit (magnetic particle chemiluminescence method)

16. Clinical trial of implantable cardiac contractility regulator

17. Clinical trial of combined nucleic acid detection kit for Streptococcus pneumoniae, Mycoplasma pneumoniae and Haemophilus influenzae

 

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CMDE

Technical Review Criteria:

Tumor gene mutation detection reagent

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CMDE

What risk factors need to be taken into consideration in the design and development of craniofacial internal fixation system products?

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CMDE

How should the pulp capping test be conducted for the light-cured calcium hydroxide pulp capping agent?

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