CDSCO Manufacturing License for Pleural manometer

Introduction

The Central Drugs Standard Control Organization (CDSCO) of India is a vital regulatory body that ensures the quality, safety, efficacy, and availability of drugs and medical devices across the country. Ensuring public health, it is acclaimed for establishing set standards to regulate, monitor, and control all kinds of products within its reach, from pharmaceutical drugs to medical devices.

Manufacturing licenses acquire a pivotal position in the field of medical devices. These licenses not only serve as a permit for the production of devices but also ensure that the manufacturer complies with the predefined standards of quality, safety, and efficiency. The impetus for the license further extends to ensure the safety of the end consumers and prohibits the propagation and usage of substandard products.

The focus of this article is the Pleural manometer, a resourceful device in the field of medical science. Leveraging the ongoing discussion, we endeavor to discuss its importance, uses, licensing procedure, and more. You can learn more about CDSCO and its many regulations on the official CDSCO portal.

• What is Pleural Manometer?
• The Role of CDSCO in Medical Device Regulation
• How to manufacture Pleural Manometer
• Fees for manufacturing license for the Pleural Manometer
• Why is a Manufacturing License Necessary for Pleural Manometer?
• Steps to Obtain a CDSCO Manufacturing License for Pleural Manometer
• Frequently Asked Questions (FAQs)
• Conclusion

What is Pleural Manometer?

The Pleural manometer, a device of remedial consequence, facilitates the measurement of pressure in the pleural cavity. This noninvasive device operates by converting pressure into electrical signals. It is predominantly used in the field of anesthesia and respiratory medicine, assisting in procedures involving the diagnosis and treatment of conditions in the thoracic cavity.

The Role of CDSCO in Medical Device Regulation

The inception of CDSCO revolutionized the landscape of medical drugs and devices. Its mission is to ensure the provision of safe, effective, and quality medical products to the citizens of the country. An integral part of its regulatory framework involves the classification of medical devices into four risk categories- Class A, B, C, and D, where Class A represents the lowest risk and Class D, the highest. Each risk class has a stipulated manufacturing license and associated fees. The Pleural manometer, under discussion, falls under Risk Class B.

How to manufacture Pleural Manometer

The Pleural Manometer, being a Class B medical device, requires an MD5 license for its manufacturing. Its production involves a meticulous process guided by strict protocols and regulations set by the CDSCO. Additionally, the manufacturing facility is required to ensure proper quality controls and meet various safety standards.

Fees for manufacturing license for the Pleural Manometer

The fee structure for procuring an MD5 license, required to manufacture the Pleural Manometer, is Rs. 5,000 for the license and an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Pleural Manometer?

Obtaining a manufacturing license for the Pleural manometer is not just a legal requirement but also ensures the production of a device that follows the stringent stipulations set by the governing body. Compliance with the regulatory measures helps in maintaining uniformity in quality, thereby promising safe and desirable outcomes. It also protects the patients and consumers by preventing access to subpar products.

Steps to Obtain a CDSCO Manufacturing License for Pleural Manometer

The process for acquiring a manufacturing license involves:

1. Preparation of necessary documents such as the Device Master File, Quality Management Certificate, Device Details, Site details, and more.
2. Submitting the consolidated application to the concerned authority.
3. Successful review and approval of the application by the regulatory body.
4. Overcoming potential challenges by adhering to the specific guidelines and seeking expert assistance as needed.

Read more about obtaining an MD5 license here.

Frequently Asked Questions (FAQs)

Q. What is the risk class of Pleural Manometer as per Medical Device Rules, 2017?

• Pleural Manometer is a Class B medical device as per the Medical Device Rules, 2017.

Q. What license is needed to manufacture Pleural Manometer?

• An MD5 license is required to manufacture Pleural Manometer.

Q. What is the fee for MD5 License for Pleural Manometer?

• The fee for the MD5 license is Rs. 5,000, with an additional Rs. 500 per product.

Q. Who will issue the manufacturing license for Pleural Manometer?

• For Class B devices such as the Pleural Manometer, the state FDA will issue the license.

Q. Is repackaging of Pleural Manometer considered manufacturing?

• Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs, and by extension, medical devices are considered manufacturing. Thus, repackaging of Pleural Manometer requires an MD5 license.

Conclusion

Understanding all regulations and successfully navigating through the licensing process could require expert assistance. At Pharmadocx Consultants, we offer consultation and guidance to help you through this complex process. Feel free to reach out to us through our website, or give us a call at +91-7404557227, or email us at [email protected] for any assistance you may need regarding the licensing process. We're here to help you ensure that the procedures comply with all regulations, making the journey from manufacturing to marketing a lot smoother.