Published on

CDSCO Manufacturing License for Bronchoscopy tube

Authors
  • avatar
    Name
    CDSCO Licenses Blog
    Twitter

Introduction

CDSCO, a synonym for Central Drugs Standard Control Organization, is a prestigious authority of India that regulates the safety, efficacy, and quality of medical devices, drugs, cosmetics, and diagnostics in the country. Given the vital role these devices play in healthcare, obtaining a manufacturing license is an essential and stringent process overseen by the CDSCO. Today, our spotlight will be on the Bronchoscopy tube, a Class C medical device widely used in anesthetic procedures. Detailed information about the CDSCO and its functions can be accessed through their official portal here.

What is a Bronchoscopy Tube?

A Bronchoscopy tube is a medical device inserted orally into a patient's airway. It serves the crucial purpose of ensuring airway patency, delivering anesthetic inhalation agents, and securing ventilation during diagnostic or therapeutic bronchoscopy using a flexible bronchoscope. This device is commonly used in surgical procedures requiring sedation and plays a central role in maintaining patient breathing during these procedures.

Role of CDSCO in Medical Device Regulation

Since its inception, the CDSCO has been the torchbearer for ensuring safety and efficacy in the country's healthcare sector. With the primary mission of safeguarding public health in India, CDSCO oversees a comprehensive regulatory framework related to medical devices. This framework guides the manufacturing, import, sale, and distribution of medical devices in India.

How to Manufacture a Bronchoscopy Tube

Since the Bronchoscopy Tube falls under Class C, it needs to comply with specific manufacturing standards and requirements stipulated by CDSCO. The manufacturing process includes necessary design, prototyping, testing, regulatory approval, and mass production steps.

Fees for Manufacturing License for a Bronchoscopy Tube

To manufacture a Class C device like a Bronchoscopy tube, a MD9 license is needed. The fee for the MD9 license is Rs. 50,000, and an additional fee of Rs. 1,000 per product is charged.

Why is a Manufacturing License Necessary for a Bronchoscopy Tube?

A manufacturing license is a regulatory necessity that ensures the production facility adheres to certain quality standards. It helps ensure patient safety by enforcing rules and regulations related to the design and manufacturing of such medical devices. Moreover, regulatory compliance is a notable feature of the healthcare sector that ensures patient rights are upheld. Lastly, it protects consumers and patients from potentially hazardous substandard products.

Steps to Obtain a CDSCO Manufacturing License for a Bronchoscopy Tube

  1. Compile necessary documents like the Device Master File, Quality Management Certificate, device details, and site details.
  2. Submit the application along with the requisite documentation to CDSCO.
  3. Await the approval of your application.
  4. Upon approval, start the manufacturing process while adhering to all regulations.

Getting a manufacturing license can be challenging. However, with the right guidance, these challenges can be easily overcome.

Frequently Asked Questions (FAQs)

  1. Q. What is the risk class of Bronchoscopy Tube as per Medical Device Rules, 2017? A. The risk class of Bronchoscopy Tube is Class C.

  2. Q. What license is needed to manufacture a Bronchoscopy Tube? A. An MD9 license is required to manufacture a Bronchoscopy Tube.

  3. Q. What is the fee for an MD9 license for a Bronchoscopy Tube? A. The fee for an MD9 license is Rs. 50,000, and an additional fee of Rs. 1,000 per product is charged.

  4. Q. Who will issue the manufacturing license for a Bronchoscopy Tube? A. For Class C medical devices like the Bronchoscopy Tube, the CDSCO HQ in New Delhi will issue the license.

  5. Q. Is repackaging of a Bronchoscopy Tube considered manufacturing? A. Yes, repackaging of a Bronchoscopy Tube is considered manufacturing and requires an MD9 license.

For queries on MD9 license, kindly see this article.

Conclusion

Understanding the procedural aspects of obtaining a manufacturing license can be tricky. If you need professional assistance, feel free to reach out to the experts at Pharmadocx Consultants, either by calling +91-7404557227 or by sending an email to [email protected]. They can provide comprehensive guidance on the licensing process, ensuring you get the best possible advice.

cdsco import license in india banner
cdsco manufacturing license in india banner