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CFDA Issued Five New Medical Device Registration Guidelines

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October 9th 2017, China Food and Drug Administration (CFDA) issued five new registration guidelines.

Guideline List
  • ELIASA Registration Guidelines
  • Disposable ECG electrodes Registration Guidelines
  • Dynamic blood pressure measuring instrument Registration Guidelines
  • Electrocardiograph Registration Guidelines (2017 revised version)
  • Patient care products (category 2) Registration Guidelines (2017 revised version)

Guideline Applicable Scope

GuidelineApplicable Scope
ELIASA Registration Guidelines
CN:酶标仪注册技术审查指导原则
This guideline applies to the general ELIASA only for the ELIASA experimental results comparation and measuring the absorbance of each test microaperture.
This guideline also applies to the automatic enzyme-linked immunity analyzer reading module.
Disposable ECG electrodes Registration Guidelines
CN:一次性使用心电电极注册技术审查指导原则
This guideline applies to the class II Disposable ECG electrodes products in the ‘Medical Device Classification Catalog’(CFDA, 2001, the 302th). The MD code is 6821.
Not apply to: Active electrode and needle electrode, reuseable(none disposable) electrode, energy transfer electrode, physiological signals except ECG signal of electrode
(Ex: resistance tracing in the apnea monitoring.
Dynamic blood pressure measuring instrument Registration Guidelines
CN:动态血压测量仪注册技术审查指导原则
This guideline applies to (noninvasive) electronic pressure artery blood pressure measurement device for the completion of indirect measurement within certain intervial by Oscillographic method or his sound method through the cuff, sensors to obtain the pressure signal.
Not apply to: Other methods of ambulatory blood pressure measurement equipments.
Electrocardiograph Registration Guidelines (2017 revised version)
CN:心电图机注册技术审查指导原则(2017年修订版)
This guideline applies to class II Electrocardiogram products in the ‘Medical Device Classification Catalog’(CFDA, 2001, the 302th). The MD code is 6821.
Patient care products (category 2) Registration Guidelines (2017 revised version)
CN:病人监护产品(第二类)注册技术审查指导原则(2017年修订版)
This guideline applies to class II noninvasive monitoring products in the ‘Medical Device Classification Catalog’(CFDA, 2001, the 302th). The MD code is 6821.
Not apply to: Class III patient monitoring products.

* If you have any comments or questions, please contact us at md@cirs-group.com

  

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