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CDSCO Manufacturing License for Cardiopulmonary bypass heart-lung machine console

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is the principal regulatory body in India responsible for ensuring the safety, efficacy, and quality of drugs, cosmetics, diagnostics, and medical devices. One of its main functions includes granting the manufacturing licenses needed within the field of medical device production. This regulatory oversight is critical to ensuring that all medical devices are produced to high standards and are safe for patient use.

One such medical device that requires a CDSCO manufacturing license is the Cardiopulmonary Bypass Heart-Lung Machine Console. This unique device plays a critical role in life-saving cardiovascular surgeries, providing a temporary means for respiratory and circulatory functions during cardiac and other medical procedures. To learn more about how to manufacture such a device under the regulatory framework of CDSCO, visit their portal here.

What is a Cardiopulmonary Bypass Heart-Lung Machine Console?

A Cardiopulmonary Bypass Heart-Lung Machine Console is an essential device used in the field of heart surgery. It interfaces with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.

This machine temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content within the body.

The Role of CDSCO in Medical Device Regulation

Founded under the Ministry of Health and Family Welfare, Government of India, CDSCO is responsible for standardisation and quality control of drugs, cosmetics and medical devices. This includes developing a regulatory roadmap, conducting clinical trials, and providing expert advice to the government.

CDSCO's regulatory framework for medical devices is designed to ensure that all products are safe, effective, and maintain the highest quality.

How to manufacture a Cardiopulmonary Bypass Heart-Lung Machine Console

Manufacturing a Cardiopulmonary Bypass Heart-Lung Machine Console involves several steps, from design and development to quality control and testing. It requires adherence to CDSCO's regulatory guidelines and obtaining the necessary licenses.

Fees for manufacturing license for a Cardiopulmonary Bypass Heart-Lung Machine Console

For a Class B device like the Cardiopulmonary Bypass Heart-Lung Machine Console, the required license is MD5. The fees for obtaining an MD5 license are Rs. 5,000 for the license and Rs. 500 per product.

Why is a Manufacturing License Necessary for a Cardiopulmonary Bypass Heart-Lung Machine Console?

Obtaining a manufacturing license is mandatory to ensure quality and safety standards. It ensures regulatory compliance within the healthcare sector and protects consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for a Cardiopulmonary Bypass Heart-Lung Machine Console

  1. Documentation: Submit necessary documents like Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Application submission: Submit your application along with necessary fees and documents.
  3. Evaluation: CDSCO will evaluate your application.
  4. Approval: Upon successful evaluation, you will be granted a manufacturing license.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of a Cardiopulmonary Bypass Heart-Lung Machine Console as per Medical Device Rules, 2017? Risk class of a Cardiopulmonary Bypass Heart-Lung Machine Console is Class B.

Q2. What license is needed to manufacture a Cardiopulmonary Bypass Heart-Lung Machine Console? The MD5 license is required to manufacture a Cardiopulmonary Bypass Heart-Lung Machine Console.

Q3. What is fees for MD5 license for a Cardiopulmonary Bypass Heart-Lung Machine Console? The fees for an MD5 license are Rs. 5,000 for the license and Rs. 500 per product.

Q4. Who will issue manufacturing license for a Cardiopulmonary Bypass Heart-Lung Machine Console? For Class B devices like the Cardiopulmonary Bypass Heart-Lung Machine Console, the state FDA will issue the license.

Q5. Is repackaging of a Cardiopulmonary Bypass Heart-Lung Machine Console considered manufacturing? Yes. As per the definition in the Drugs and Cosmetics Act, repackaging of drugs is considered manufacturing. By further definitions, medical devices are also drugs, and the repackaging of a Cardiopulmonary Bypass Heart-Lung Machine Console is also considered manufacturing, requiring an MD5 license.

Conclusion

Navigating the regulatory landscape for medical devices in India can be a challenging process. Whether you're a start-up or an established company, regulatory compliance is crucial in delivering safe and effective products to market. For assistance with obtaining a CDSCO manufacturing license, reach out to Pharmadocx Consultants or call +91-7404557227 or email [email protected].

Further reading: MD5 License for Class A & B Medical Devices

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