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CDSCO Manufacturing License for Oxygen/air/nitrous oxide breathing gas mixer

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Introduction

The Central Drugs Standard Control Organization (CDSCO) in India is the national regulatory body for Indian pharmaceuticals and medical devices, akin to the Food and Drug Administration (FDA) in the United States. The main responsibility of CDSCO under the Ministry of Health & Family Welfare includes maintaining quality in the country's drug, pharmaceutical, and medical devices sector, thereby safeguarding and promoting public health and welfare.

In the realm of the healthcare industry, manufacturing licenses are of paramount importance. The licenses ensure that the manufacturing processes and facilities involved in the production of medical devices comply with guidelines set by the regulatory body, ensuring quality assurance and safety standards.

Today, we delve into the CDSCO manufacturing license for a medical device that has been integral to the field of medical sciences, the Oxygen/Air/Nitrous Oxide Breathing Gas Mixer. Visit the CDSCO's portal to learn more about medical device licensing, CDSCO's Portal.

What is Oxygen/Air/Nitrous Oxide Breathing Gas Mixer?

A breathing gas mixer is a device that is specifically designed for accurate mixing of oxygen (O2), air, and nitrous oxide (N2O) in predetermined concentrations that are considered safe for breathing. It is an essential component often used by healthcare professionals in the field of anesthesiology.

The major uses of an Oxygen/Air/Nitrous Oxide Breathing Gas Mixer are in administering anesthesia to patients during surgeries and for oxygen therapy treatments.

The Role of CDSCO in Medical Device Regulation

The Central Drugs Standard Control Organization (CDSCO) was constituted to control and supervise the standard of imported and home-made drugs in India. Its mission is "to safeguard and enhance public health by ensuring safety, efficacy, and quality of drugs, cosmetics, and medical devices."

CDSCO's regulatory framework for medical devices includes classification of medical devices into four classes - A, B, C, and D based on associated risk levels, with Class A being the lowest risk and Class D being the highest.

How to manufacture Oxygen/Air/Nitrous Oxide Breathing Gas Mixer

Manufacturing this device involves numerous stages, from design and development to production, quality testing, and packaging. Ensuring adherence to CDSCO's regulations and acquiring the needed licenses is integral to the process.

Fees for manufacturing license for Oxygen/Air/Nitrous Oxide Breathing Gas Mixer

Given that it falls under Risk Class C, an MD9 license is required for manufacturing the Oxygen/Air/Nitrous Oxide Breathing Gas Mixer. The fees for MD9 are Rs. 50,000 for the license and an additional Rs. 1,000 per product. Learn more about MD9 license process in this article.

Why is a Manufacturing License Necessary for Oxygen/Air/Nitrous Oxide Breathing Gas Mixer?

  1. It's a legal requirement to have a manufacturing license for the production of Class C devices like the Oxygen/Air/Nitrous Oxide Breathing Gas Mixer.
  2. A manufacturing license ensures the quality and safety of the medical device, protecting patients who use these devices.
  3. Compliance with regulatory requirements protects manufacturers from legal complications, promoting overall industry growth.
  4. It shields consumers from substandard products, thereby building trust in the manufacturer and the healthcare sector as a whole.

Steps to Obtain a CDSCO Manufacturing License for Oxygen/Air/Nitrous Oxide Breathing Gas Mixer

  1. Collate all necessary documents such as Device Master File, Quality Management Certificate, Device Details, Site details.
  2. Submit the application for the manufacturing license.
  3. Wait for the evaluation and approval process.
  4. Address any queries or issues raised during the process.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of the Oxygen/Air/Nitrous Oxide Breathing Gas Mixer as per Medical Device Rules, 2017?
The risk class is C.

Q2. What license is needed to manufacture the Oxygen/Air/Nitrous Oxide Breathing Gas Mixer?
MD9 license is required.

Q3. What is the fee for the MD9 license for the Oxygen/Air/Nitrous Oxide Breathing Gas Mixer?
The fee for MD9 license is Rs. 50,000 for the license and further Rs. 1,000 per product manufactured.

Q4. Who will issue a manufacturing license for the Oxygen/Air/Nitrous Oxide Breathing Gas Mixer?
The manufacturing license for Class C medical devices is issued by CDSCO HQ in New Delhi.

Q5. Is the repackaging of the Oxygen/Air/Nitrous Oxide Breathing Gas Mixer considered as manufacturing?
Yes, as per the Drugs and Cosmetics Act's definition, repackaging of drugs and by further definitions, medical devices too, are considered as manufacturing. Hence, the repackaging of Oxygen/Air/Nitrous Oxide Breathing Gas Mixer would also necessitate an MD9 license.

Conclusion

Endeavoring to manufacture medical devices demands a considerable comprehension of the licensing process. If the licensing process seems daunting, reach out to us for any consultation or assistance. Reach us on "+91-7404557227" or drop us an email at [email protected]. We're here to simplify and streamline your journey in the medical devices' world.

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