在印度开设雾化器制造单元的首要理由

在印度开设雾化器制造单元的首要理由

The age group who are affected with the respiratory problems get relieved with help of Nebulization. A Nebulizer is a small machine that creates a mist out of liquid medication, allowing for quicker and easier absorption of medication into the lungs through nebulizer mask. It is less expensive and easy adaptable and commonly used for respiratory problems like chest congestion,Asthama etc.雾化器是低至中等风险的医疗设备,根据MDR2017需要强制性注册。

CDSCO将是中央许可机构,将批准印度雾化器制造过程的申请。制造商需要申请CDSCO制造许可证和我们的团队将协助您完成表示“允许”sing process. The manufacturer of these products should follow the safety and efficacy principal as per the given guidelines. The person who wants to start the nebulizer manufacturing unit should be aware of manufacturing and regulatory process. Usually, nebulizers come in both electric or battery-run versions, and are both transportable (so you can bring with you) or supposed to sit down on a table and plug into a wall.

Both versions of  nebulizers are made up of:

  • a base that holds an air compressor
  • a small container for liquid medication
  • a tube that connects the air compressor to the drugs container

在药物容器上方是您用来吸入雾气的烟嘴或口罩。

雾化器的类型:

Nebulizers have three types:

  • Jet Nebulizers:  Make an aerosol out of medicines using a compressed gas (like air). These are the common sort of nebulizers.
  • Ultrasonic nebulizers:这些更常用于医院,通常不供个人使用。
  • Mesh nebulizers:Mesh nebulizers use a mesh cap with tiny holes that help dispense medicine in a totally efficient manner. Those nebulizers are more modern and frequently extra powerful than jet nebulizers.

雾化器制造的技术特征:

  • Manufactured from soft, non-toxic medical grade material.
  • 由清晰的气溶胶面膜制成,非常适合长期使用。
  • Star lumen tube to avoid fortuitous blockage.
  • 由抗扭结的PVC管组成。
  • 融合的 nasal clip for stable fixation over the patient’s nose.
  • Elastic strap/band is for proper mask placement.
  • Tube length: 200cm.

Nebulizers Manufacturing Process:

注射成型机

注射成型ISA使用模具形成过程。加热和融化等材料(例如人造树脂(塑料)),然后将其冷却到可以塑造设计形式的模具中。由于与使用注射器注入液体的技术相似,因此该系统称为注射成型。

Mechanical

这种设备用于切换机器以构建机器侧面的吨位,这不会因注入压力而打开。

液压

This machines despite are not that nearly precise, and are the predominant type in most of the world.

Electric

电机也称为电动机技术,通过减少能源消耗来降低成本。据说电动机更安静,更快,并且具有最佳的准确性。

Sterilization plant

For the sterilization process here, they must use ethylene oxide. Ethylene oxide (ETO) referred as the gas used for low-temperature sterilization. It’s normally used to sterilize instruments or devices and all those products that have to be sterilized but cannot stand high temperatures.

雾化器制造中使用的原材料:

  1. Polyvinyl chloride (PVC)
  2. Elastic strap/band
  3. Acrylonitrile butadiene styrene (ABS)
  4. 聚丙烯(PP)
  5. High density polyethylene (HDPE)

雾化器如何工作?

雾化器通过加压空气提供液体药物。尽管患有哮喘的人通常同时使用雾化器和吸入器,但偶尔会使用雾化器,但是当呼吸道变得狭窄时(例如在哮喘发作期间)时,雾化器易于使用,因为雾化器大多是首选,因为雾化器可能需要一些时间来设置。

雾化器中使用的药物的例子包括:

  • 支气管扩张剂 are drugs that help to open up the airway.
  • Medical-grade saline (saltwater) solutions are solutions that help break up mucus in the lungs.
  • Antibiotics are used to treat infections.

The Use of Nebulizers in different conditions, includes:

  • 慢性阻塞性肺疾病(COPD)
  • 哮喘
  • bronchiectasis
  • cystic fibrosis
  • pulmonary fibrosis

雾化器也有助于提供药物 姑息治疗 and to very young children

启动雾化器制造单元的主要原因?

Growth has been seen in Nebulizer manufacturing, as per the data from various sources the revenue from the industry is expected to grow by 6.5% through 2020 to 2027.Nebulizers are part of home care services. One can encash the opportunity lies in nebulizer manufacturing market. Driving factors which are contributing in Nebulizers manufacturing process are:

  • 市场规模不断增长 - 由于呼吸道疾病和COVID-19的爆发加速了对雾化器的需求。
  • Home care service product – Large number of people especially geriatric population opting to buy medical equipment for home use.
  • Technological advancement.
  • Government encouraging medical device manufacturing start-up by launching news schemes and updating regulations to reduce import dependency.

简而言之,我们可以说,医疗保健设备的技术进步,全球越来越多的老年患者在市场繁荣时期做出了贡献。这些因素在雾化器市场中显示出巨大的机会,这些机会吸引了制造商 /进口商开始这项合资企业。这些制造商/进口商在进入市场之前应考虑所有必要的法规。作为medical device regulatory consultant我们为医疗设备制造商以及整个制造业的进口商提供帮助,以进行监管完成。您可以轻松地与我们联系,以获取与此相关的任何查询。

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