Medical Nebulizer CFDA Registration Inspection Concerns - Regulatory News - Medical Devices

On April 6^th 2016, CFDA issued the “Technical Guidelines for Medical Nebulizer (2016 revised edition)”. This guideline clearly stated the Medical Nebulizer registration inspection concerns from China Food and Drug Administration (CFDA).

Medical Nebulizer CFDA Registration Inspection Concerns

If the products’ electric safety performance and basic technical performance are subject to the national and industry mandatory standards. Whether the performance index can satisfy the products safety and effectiveness requirements or not. Whether or not manufactures made the request of the particle size distribution of atomized particles equivalent volume.
The particle size distribution of atomized particles equivalent volume is a technical index that will have direct influence on the products safety and effectiveness. And this requirement is listed in the industry standard YY0109—2013 ‘Medical Nebulizer’. Also it is the focused verification point for the CFDA inspection.
The manual should inform the users if the information is complete. Ex: specify the product using environment, applicable users and restricted medicine types. If the products include the disposable part, the product manual should include the PRECAUTIONS FOR USE.
If the product main risk has been listed. And the product safety can be controlled within a reasonable and acceptable range through risk control measures.
The manufactures should clearly indicate the pharmaceuticals containers and pharmaceuticals contacting parts. Also they should explain whether these materials added plasticizer or not. If added, they should illustrate the safety.

Chart 1 Related Product Standards

GB/T 191—2008	‘Packing & Storage symbol’ 包裝儲運圖示標志
GB 9706.l—2007	‘Medical Device Electrical Equipment, Part One :safety general requirements’ 醫用電氣設備第1部分:安全通用要求
GB/T 14233.1—2008	‘Medical Infusion, Blood Transfusion, Injection Apparatus Test Method, Part 1: chemical analysis methods’ 醫用輸液、輸血、注射器具檢驗方法第1部分：化學分析方法
GB/T 14710—2009	‘Medical Electrical Equipment Setting Requirement and Testing Methods’ 醫用電器環境要求及試驗方法
GB 15980—1995	‘Sanitary Standards for Single Use Medical Supplies’ 一次性使用醫療用品衛生標準
GB/T 16886.1—2011	‘Medical device biological evaluation, part one: The evaluation and tests in the risk management process’ 醫療器械生物學評價第1部分：風險管理過程中的評價與試驗
GB/T 16886.5—2003	‘Medical device biological evaluation, part five: cytotoxicity tests’ 醫療器械生物學評價第5部分：體外細胞毒性試驗
GB/T 16886.7—2001	‘Medical device biological evaluation, part 7: residual quantity of ethylene oxide’ 醫療器械生物學評價第7部分：環氧乙烷殘留量
GB/T 16886.10—2005	‘Medical device biological evaluation, part ten: stimulation and delayed hypersensitivity reaction tests’ 醫療器械生物學評價第10部分：刺激與遲發型超敏反應試驗
GB/T 16886.12—2005	‘Medical device biological evaluation- part 12: Sample preparation and reference sample’ 醫療器械生物學評價第12部分：樣品制備與參照樣品
YY 0109—2013	'Medical Ultrasonic Nebulizer' 醫用超聲霧化器
YY 0505—2012	‘Medical Electrical Equipment- part 1-2: safety general requirement collateral standard: electromagnetic compatibility requirements and test’ 醫用電氣設備第1—2部分:安全通用要求并列標準:電磁兼容要求和試驗
YY 0671.2—2011	'Sleep Apnea Therapy - Part 2: mask and application accessories' 睡眠呼吸暫停治療第2部分：面罩和應用附件
YY/T 0466.1—2009	‘Medical Device for the Medical Device Label, Mark and Information Provided Symbols, Part one: general requirement’ 醫療器械用于醫療器械標簽、標記和提供信息的符號第1部分：通用要求
EN 13544—1:2007	'Respiratory therapy equipment-Part 1： Nebulizing systems and their components'

Related links:

Foreign Medical Device Applicant are Required to Supplement the Chinese Information to CFDA
Preparation of Medical Device Technical Requirements
Regulations & Know-how
Classification and Category of Medical Devices in China
Medical Nebulizer Registration Guideline
Free Webinar! CFDA New Notification about Standardize the Use of Chinese Name for Foreign Medical Device CFDA Registration
How to Compile Clinical Evaluation for Medical Nebulizer CFDA Registration

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