Technical Review Guideline Of Pulse Oximeter Registration 2017

Appendix 4
Technical Review Guideline of Pulse Oximeter
Registration
(2017 Revision)
This guiding principle is intended to provide a reference for
registration applicants to prepare and write registration documents
for pulse oximeters, as well as for the technical review department to
review registration documents. This guideline is formulated under the current laws and
regulations, standard systems and current levels of awareness. With
the continuous improvement of laws and regulations and standard
systems and the continuous development of science and technology, the relevant content of this guideline will also be adjusted in due
course. This guideline is a guideline document for applicant and
reviewer. It does not involve administrative matters such as
registration and approval, nor is it enforced as a regulation. If there
are other methods that can meet the requirements of the laws and
regulations, it can also be used, but detailed study and verification
documents shall be provided. This guideline shall be used in
accordance with relevant laws and regulations. This guideline is a general requirement for the product. The
—2——
applicant shall determine whether the content is applicable
according to the specific characteristics of the product. If not, the
reason and corresponding scientific basis shall be explained in
detail, and the content of clinical evaluation data shall be enriched
and refined according to the specific characteristics of the product. I. Application Scope
This guideline applies to the pulse oximeters in the Class II
non-invasive monitoring instrument products, which can measure
and display pulse oxygen saturation and pulse rate. This guideline does not apply to pulse oximeter equipment for
laboratory studies, pulse oximeter equipment for fetuses and
telemetry or master (slave) equipment placed outside the patient
environment that displays SpO2 values. II. Key Points of Technical Review
(I) Product Name Requirements
The naming of pulse oximeter products shall refer to the
Naming Rules for Common Names of Medical Devices (National
Medical Products Administration Order No. 19) or the common
names on national standards and industry standards, such as: pulse
oximeter, pulse oxygen measuring instrument, pulse oxygen
monitor. (II) Product Structure and Composition
The structure of a pulse oximeter is generally composed of a
pulse oximeter host, a blood oxygen probe, and a probe extension
cable (if provided)