CFDA Issued Five New Medical Device Registration Guidelines - Regulatory News - Medical Devices

October 9^th 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

Guideline	Applicable Scope
ELIASA Registration Guidelines CN:酶標儀注冊技術審查指導原則	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:一次性使用心電電極注冊技術審查指導原則	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:動態血壓測量儀注冊技術審查指導原則	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:心電圖機注冊技術審查指導原則（2017年修訂版）	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:病人監護產品（第二類）注冊技術審查指導原則（2017年修訂版）	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.

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