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CDSCO Manufacturing License for Non-heated respiratory humidifier

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in the Indian healthcare sector, responsible for safeguarding and enhancing public health by ensuring the quality, safety, and efficacy of drugs, cosmetics, and medical devices. CDSCO falls under the purview of the Union Ministry of Health and Family Welfare and oversees all regulatory measures and guidelines linked to pharmaceuticals and medical devices.

In the dynamic landscape of the medical device industry, obtaining the requisite manufacturing licenses is crucial. These licenses, rigorously regulated and systematically classified based on risk-levels, are a testament to the stringent measures in place to ensure devices being manufactured conform to the highest standards of safety and efficacy.

Join us as we explore the world of "Non-heated respiratory humidifiers" - an essential medical device that plays a key role in various therapeutic respiratory therapies. A thorough understanding of these devices, along with the related regulations and licensing processes, is vital for manufacturers. Stay updated with the latest guidelines by visiting CDSCO's dedicated portal here.

What is a Non-heated Respiratory Humidifier?

A Non-heated respiratory humidifier is a specialized device designed to add water vapor to dry gas - typically oxygen, during inhalation. This process aids in preventing dryness in the airway passages that can occur with the prolonged use of oxygen.

These devices form an integral part of various medical procedures and therapies, especially those related to respiratory concerns. Their function can enhance patient comfort and therapy effectiveness, proving to be an indispensable asset in the healthcare sector.

The Role of CDSCO in Medical Device Regulation

CDSCO, since its inception, has been instrumental in shaping the healthcare landscape in India, chiefly by regulating and monitoring the manufacturing and sales processes involved with drugs and medical devices.

The organization's regulatory framework for medical devices is robust and comprehensive, meticulously categorizing devices into different risk classes – A, B, C, and D. A Class A device represents the lowest degree of risk, whereas a Class D device signifies the highest level of risk.

How to Manufacture a Non-heated Respiratory Humidifier

Manufacturing a Non-heated respiratory humidifier demands compliance with a series of regulatory stipulations. The process involves an intricate mix of engineering, medical science, and meticulous adherence to manufacturing guidelines set forth by CDSCO.

Fees for Manufacturing License for Non-heated Respiratory Humidifier

The licensing fee for a Class B device such as the Non-heated respiratory humidifier requires an MD5 license. The licensing fee is Rs. 5000, while each product registration demands an additional fee of Rs. 500.

Why is a Manufacturing License Necessary for a Non-heated Respiratory Humidifier?

A manufacturing license is more than a legal requisite for a medical equipment manufacturer; it's a symbol of assurance that a given product is safe, effective, and adheres to international quality standards.

Manufacturing medical devices with compliance to CDSCO requirements ensures that every product released into the market meets predefined quality parameters, protecting consumers and patients from subpar or potentially harmful products.

Steps to Obtain a CDSCO Manufacturing License for a Non-heated Respiratory Humidifier

The process of obtaining a manufacturing license from CDSCO involves the following steps:

  1. Prepare the necessary documents, including Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submit the prepared documents to the relevant regulatory body.
  3. Await approval after the documents undergo scrutiny and verification.
  4. Address any queries or challenges that may arise during the verification process.

You can gain more information regarding the MD5 license from this article.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Non-heated Respiratory Humidifier as per Medical Device Rules, 2017?

The Non-heated Respiratory Humidifier is classified as a Class B device.

Q2. What license is needed to manufacture a Non-heated Respiratory Humidifier?

An MD5 license is required for the manufacture of a Non-heated Respiratory Humidifier.

Q3. What is the fee for an MD5 license for a Non-heated Respiratory Humidifier?

The licensing fee for an MD5 license is Rs. 5000, and the product registration fee is Rs. 500 per product.

Q4. Who will issue the manufacturing license for a Non-heated Respiratory Humidifier?

For Class B devices such as the Non-heated Respiratory Humidifier, the state FDA will issue the license.

Q5. Is repackaging of Non-heated Respiratory Humidifier considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging is considered manufacturing. Therefore, repackaging of a Non-heated Respiratory Humidifier is also considered manufacturing and requires an MD5 license.

Conclusion

The process of obtaining a CDSCO manufacturing license may seem complicated and daunting initially, however, by aligning with the regulatory guidelines and with proper guidance, it can be well navigated. If you're a medical device manufacturer seeking further assistance or consultation regarding the licensing procedure, feel free to reach out to Pharmadocx Consultants. For immediate assistance, you can call on +91-7404557227 or email us at [email protected].

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