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CDSCO Manufacturing License for Helium/oxygen breathing gas mixer

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is the backbone of India's healthcare sector, responsible for approving drugs, pharmaceuticals, and medical devices to ensure the welfare and safety of Indian consumers. They play a pivotal role in the medical device industry, ensuring that these products meet rigorous safety and performance standards. One such medical device is the Helium/oxygen breathing gas mixer, a critical tool in anaesthesia and respiratory care.

Within the realm of medical devices, the CDSCO categorizes devices based on the potential risks tied to their use, identifying them as Class A, B, C, or D, in ascending order of risk. With this in mind, the Helium/oxygen breathing gas mixer falls under risk class B. To manufacture such a device, one must acquire the necessary licenses from the relevant authorities, ensuring compliance with regulations outlined by CDSCO. You can refer to CDSCO's portal for more comprehensive information.

What is a Helium/oxygen breathing gas mixer?

A Helium/oxygen breathing gas mixer is an independent mechanical device that precisely mixes helium (He) and oxygen (O2), attaining concentrations suitable for a patient's respiration. This device is commonly used in procedures that require the assistance of adequate oxygen flow into a person’s alveoli, ultimately reducing the work of breathing during anaesthetic operations.

The Role of CDSCO in Medical Device Regulation

The CDSCO's mission is centered around the safeguarding of public health in India. To fulfill this mission, they've established a regulatory framework for medical devices. The Helium/oxygen breathing gas mixer, under this framework, requires a manufacturing license - specifically, an MD5 license due to its classification as a Class B medical device.

How to manufacture a Helium/oxygen breathing gas mixer

Proper manufacturing of a Helium/oxygen breathing gas mixer is regulated under the care of the CDSCO. It's essential for manufacturers to follow CDSCO guidelines in a bid to ensure consistent quality, efficacy, and safety in the units produced.

Fees for the manufacturing license for a Helium/oxygen breathing gas mixer

For a Class B device like the Helium/oxygen breathing gas mixer, the required license is MD5. The fees associated with this license amount to Rs. 5,000, with an additional Rs. 500 charged per product.

Why is a Manufacturing License Necessary for a Helium/oxygen breathing gas mixer?

A manufacturing license is mandatory for a Helium/oxygen breathing gas mixer. The reason behind this regulation is twofold - Primarily, it ensures a consistent quality in production. Secondly, it safeguards patients and consumers from substandard products, aligning with CDSCO's goal of maintaining a high caliber of healthcare devices in the Indian market.

Steps to Obtain a CDSCO Manufacturing License for a Helium/oxygen breathing gas mixer

When applying for an MD5 manufacturing license under the CDSCO, there are several prerequisites to consider:

  1. Device Master File
  2. Quality Management Certificate
  3. Device Details
  4. Site Details

The application process, though potentially challenging, can be navigated with diligence:

  1. Submission of an application including all the required documents.
  2. Assessment for compliance with CDSCO's quality standards.
  3. If successful, the state FDA will issue the license.
  4. The license will need renewal, adhering to its stipulated duration.

Frequently Asked Questions (FAQs)

Q1: What is the risk class of a Helium/oxygen breathing gas mixer as per Medical Device Rules, 2017? A1: The Helium/oxygen breathing gas mixer falls under risk class B.

Q2: What license is needed to manufacture a Helium/oxygen breathing gas mixer? A2: To manufacture a Helium/oxygen breathing gas mixer, an MD5 license is required.

Q3: What are the fees for an MD5 license for a Helium/oxygen breathing gas mixer? A3: The fee for an MD5 license is Rs. 5,000, with an additional Rs. 500 per product.

Q4: Who will issue the manufacturing license for a Helium/oxygen breathing gas mixer? A4: For Class B devices like the Helium/oxygen breathing gas mixer, the state FDA will issue the license.

Q5: Is repackaging of a Helium/oxygen breathing gas mixer considered manufacturing? A5: Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and similarly, medical devices are also classified under drugs. Hence, repackaging of a Helium/oxygen breathing gas mixer requires an MD5 license.

Conclusion

Obtaining a CDSCO manufacturing license can be a complex task, especially if you lack the relevant knowledge or experience. Fortunately, our team at Pharmadocx Consultants is here to guide you through the process. Feel free to call us at +91-7404557227 or drop an email at [email protected] for more information.

For more information regarding the MD5 license specifically, please refer to the following article: MD5 License

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