CDSCO Manufacturing License for Airway pressure/oxygen monitor

Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's key regulatory agency for pharmaceuticals and medical devices. As a subsidiary of the Ministry of Health & Family Welfare, Government of India, CDSCO is responsible for the approval of new drugs, clinical trials oversight, issuance of manufacturing licenses, and control of the quality of imported drugs. In the field of medical devices, CDSCO takes on the role of safeguarding public health by ensuring the safety, effectiveness, and quality of medical devices circulated within the country.

One crucial way through which CDSCO achieves this mandate is by issuing manufacturing licenses. Being a holder of a CDSCO license signifies that a manufacturer abides by stringent quality and safety standards. This process is non-negotiable for those intending to venture into the production of medical devices, including the Airway Pressure/Oxygen Monitor.

We delve into the fundamentals of the Airway Pressure/Oxygen Monitor, a critical medical device in the practice of anesthesia. Register and log in to CDSCO's portal here to kick start your journey in medical device manufacturing in India.

What is Airway Pressure/Oxygen Monitor?
The Role of CDSCO in Medical Device Regulation
How to manufacture Airway Pressure/Oxygen Monitor
Fees for manufacturing license for Airway Pressure/Oxygen Monitor
Why is a Manufacturing License Necessary for Airway Pressure/Oxygen Monitor?
Steps to Obtain a CDSCO Manufacturing License for Airway Pressure/Oxygen Monitor
Frequently Asked Questions (FAQs)
Conclusion

What is Airway Pressure/Oxygen Monitor?

Airway pressure/oxygen monitor is a form of non-invasive medical monitor used to measure and display the level of breathing circuit pressure and oxygen concentration of respiratory gases delivered to a patient through positive pressure ventilation systems. This real-time monitoring is essential in ensuring the safety of patients, particularly during anesthesia administration.

The Role of CDSCO in Medical Device Regulation

Since its inception, CDSCO has been playing a pivotal role in regulating medical devices in India. Its mission is to safeguard and enhance public health by ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices. CDSCO accomplishes this through a robust regulatory framework that includes stringent manufacturing licenses and post-marketing surveillance.

How to manufacture Airway Pressure/Oxygen Monitor

Fees for manufacturing license for Airway Pressure/Oxygen Monitor

The fees for manufacturing a classification B medical device such as the Airway Pressure/Oxygen Monitor are Rs. 5,000 for the MD5 license and an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Airway Pressure/Oxygen Monitor?

Given the critical role of the Airway Pressure/Oxygen Monitor in anesthesia practices, it's mandatory to obtain a manufacturing license. This necessity ensures quality and safety in medical device production, fosters compliance with regulatory procedures in the healthcare sector, and provides a safeguard for consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Airway Pressure/Oxygen Monitor

Prepare the necessary documents: Device Master File, Quality Management Certificate, Device Details, Site details, etc.
Submit the application through CDSCO portal
Await approval from regulatory authorities
Overcome common challenges such as clarifying regulation requirements

Frequently Asked Questions (FAQs)

Q. What is risk class of Airway Pressure/Oxygen Monitor as per Medical Device Rules, 2017? A: The Airway Pressure/Oxygen Monitor is a risk class B medical device.
Q. What license in needed to manufacture Airway Pressure/Oxygen Monitor? A: The manufacturing of Airway Pressure/Oxygen Monitor requires an MD5 license.
Q. What is fees for MD5 license for Airway Pressure/Oxygen Monitor? A: The fees for MD5 license are Rs. 5,000 for the license and Rs. 500 per product.
Q. Who will issue manufacturing license for Airway Pressure/Oxygen Monitor? A: The state FDA will issue the license for class B devices such as the Airway Pressure/Oxygen Monitor.
Q. Is repackaging of Airway Pressure/Oxygen Monitor considered manufacturing? A: Yes, repackaging of Airway Pressure/Oxygen Monitor is considered manufacturing and requires an MD5 license.

Conclusion

Embarking on the process to obtain the CDSCO manufacturing license for the Airway Pressure/Oxygen Monitor? Reach out to Pharmadocx Consultants. You can also call "+91-7404557227" or email at "[email protected]" for consultation or assistance regarding the licensing process. For further insights on the MD5 license for Class A and Class B medical devices, you can read this article.