Registration Guidelines for the Medical Electronic Thermometers

The Medical Electronic Thermometers regulated as class II medical devices (6820) under CFDA regulations, any foreign manufacturers are required to obtain the imported medical device registration certificate from CFDA for their medical electronic thermometers product in China. CFDA issued the revised “Technical Guidelines for Medical Electronic Thermometers (2017 revised version)”, The Medical Electronic Thermometers registration would be comply with this guidelines.

CFDA Clinical Trial Exemption
According to the “Catalog of Class II Medical Devices Exempted from Clinical Trials”(first batch 21^st Aug. 2014) , the medical electronic thermometers described as below can be exempted from clinical trials in China

Applicable Scope
Apply to:
The direct-contacting medical electronic thermometers that monitor the body temperature including the mouth, armpit or anus with interval, and according to the Medical Devices Classification Catalogue, the MD code of these medical devices is 6820.

Not apply to:
Indirect contacting thermometer, such as the infrared thermometer,
continuously measured thermometers（The product structure and performance are different from the guideline satisfied products）and other devices with temperature measurement function( only the auxiliary function), but this guideline can be reference for these devices.

Key Points of Technical Requirement
1. Product naming requirements
Medical Electronic Thermometers naming should be subject to the ‘Medical Device Classification Catalog’ or national standard or the general naming in the industry standard.
2. Product structure and components
3. Product working principle or mechanism
4. The registration unit principle and examples
With the same product working principle, the structural components, performance index and applicable scope are subject to the description listed above. These products can be the same registration unit. If the product technical structure and performance index have difference, they can be different models. Ex: Water proof and non-water proof.
Medical Electronic Thermometers used for the different testing part can be the same registration unit but they should be different models. And it should specify the testing part in the model description.
5. Product applicable related standards (click for the detailed standards)
6. Product applicable scope or intended use, contraindication
7. Product main risk
8. The main performance index of the product technical requirements

Appearance and structure requirements
Temperature display requirements
Hint function requirements
Measurement time requirement
Memory function requirement
Automatic shutdown function requirement
Patients contacting detector requirements
Performance of cooperating with the probe protection sleeve
Material requirements
Safety requirements
Electromagnetic compatibility (EMC)
Environmental test requirements

9. The same registration unit test means these products have certain principles and examples.
10. Product production and manufacturing related requirements
11. Product clinical evaluation detailed requirements.
The clinical evaluation should be subject to notification of ‘The Catalog of Class II Medical Devices Exempted from the Clinical Trials’ (CFDA 12^thNotification, 2014), ‘Medical Device Clinical Evaluation Technical Guideline’ (CFDA 12th Notification attachment, 2014) and other related documents.
12. Product adverse events record
13. Product specification and label requirements
14. Product research requirements

Product performance study
Biocompatibility evaluation study
Sterilization or disinfection process research
Product validity and packaging research
Software research

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

Related links:

STANDARD NO.	Name of the standards
GB/T 191-2008	‘Packing & Storeage symbol’ 《包装储运图示标志》
GB 9706.1-2007	‘Medical Device Electrical Equipment, Part One :safety general requirements’ 《医用电气设备第1部分：安全通用要求》
GB/T 9969-2008	‘Industrial Products Using Specification Principles’ 《工业产品使用说明书总则》
GB/T 14710-2009	‘Medical Electrical Equipment Setting Requirement and Testing Methods’ 《医用电气设备环境要求及试验方法》
GB/T 16886.1-2011	‘Medical device biological evaluation, part one: The evaluation and tests in the risk management process’ 《医疗器械生物学评价第1部分：风险管理过程中的评价与试验》
GB/T 16886.5-2003	‘Medical device biological evaluation, part five: cytotoxicity tests’《医疗器械生物学评价第5部分：体外细胞毒性试验》
GB/T 16886.10-2005	‘Medical device biological evaluation, part ten: stimulation and delayed hypersensitivity reaction tests’ 《医疗器械生物学评价第10部分：刺激与迟发型超敏反应试验》
GB/T 21416-2008	‘Medical Electronic Thermometers’《医用电子体温计》
YY/T 0316-2008	‘Medical Device Risk Management for medical devices application’ 《医疗器械风险管理对医疗器械的应用》
YY/T 0466.1-2009	‘Medical Device for the Medical Device Label, Mark and Information Symbol Part One: general requirements’ 《医疗器械用于医疗器械标签、标记和提供信息的符号第1部分：通用要求》
YY 0505-2012	‘Medical Electrical Equipment, part 1-2: safety general requirement collateral standard: electromagnetic compatibility requirements and test’ 《医用电气设备第1-2部分：安全通用要求并列标准：电磁兼容要求和试验》

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