Medical Nebulizer CFDA Registration Inspection Concerns

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’ 包装储运图示标志
GB 9706.l—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 14233.1—2008	‘Medical Infusion, Blood Transfusion, Injection Apparatus Test Method, Part 1: chemical analysis methods’ 医用输液、输血、注射器具检验方法第1部分：化学分析方法
GB/T 14710—2009	‘Medical Electrical Equipment Setting Requirement and Testing Methods’ 医用电器环境要求及试验方法
GB 15980—1995	‘Sanitary Standards for Single Use Medical Supplies’ 一次性使用医疗用品卫生标准
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 16886.7—2001	‘Medical device biological evaluation, part 7: residual quantity of ethylene oxide’ 医疗器械生物学评价第7部分：环氧乙烷残留量
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 16886.12—2005	‘Medical device biological evaluation- part 12: Sample preparation and reference sample’ 医疗器械生物学评价第12部分：样品制备与参照样品
YY 0109—2013	'Medical Ultrasonic Nebulizer' 医用超声雾化器
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
YY 0671.2—2011	'Sleep Apnea Therapy - Part 2: mask and application accessories' 睡眠呼吸暂停治疗第2部分：面罩和应用附件
YY/T 0466.1—2009	‘Medical Device for the Medical Device Label, Mark and Information Provided Symbols, Part one: general requirement’ 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
EN 13544—1:2007	'Respiratory therapy equipment-Part 1： Nebulizing systems and their components'

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