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CDSCO Manufacturing License for Pulse oximeter
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- CDSCO Licenses Blog
Introduction
CDSCO (Central Drugs Standard Control Organization) plays a pivotal role in the Indian healthcare ecosystem. Tasked with ensuring the safety, efficacy and quality of medical devices and drugs produced and imported in India, it holds a cardinal importance. The organization is bestowed upon with the responsibility of regulating the standard of imported drugs, preventing the manufacture of substandard drugs and supervising the imported cosmetics in the country.
In addition to drugs and cosmetics, CDSCO has a strong regulatory framework for the manufacturing and licensing of medical devices. One such medical device of importance is the Pulse Oximeter, a Class C medical device as per the Medical Device Rules, 2017.
Pulse Oximeter has a significant role in the healthcare sector, especially in the scenario of anesthesia, critical care, cardiac care and home health monitoring. Before delving into the details of Pulse Oximeter and it's manufacturing license, it's important to know more about the functionalities and responsibilities of CDSCO. The details of all the pertinent licences, guidelines, forms, and fees are available on the CDSCO portal, which could be reached here.
- What is Pulse Oximeter?
- The Role of CDSCO in Medical Device Regulation
- How to manufacture Pulse Oximeter
- Fees for manufacturing license for Pulse Oximeter
- Why is a Manufacturing License Necessary for Pulse Oximeter?
- Steps to Obtain a CDSCO Manufacturing License for Pulse Oximeter
- Frequently Asked Questions (FAQs)
- Conclusion
What is Pulse Oximeter?
Pulse oximeter, a non-invasive medical device, is used to measure the saturation level of oxygen in the patient's blood. Often used during surgeries or procedures which requires anesthesia, this device helps in monitoring the patient's oxygen level, thereby relieving the medical team from frequent blood test requirements.
Pulse oximeters are most commonly used to observe the oxygen saturation of a patient in different settings such as during intensive care, performing direct surgeries, during the administration of anesthesia and even for personal use at home by heart and respiratory patients.
The Role of CDSCO in Medical Device Regulation
Founded under the Ministry of Health & Family Welfare of Government of India, CDSCO is accountable for granting approval for new drugs, conducting clinical trials, laying down the standards for drugs, controlling the quality of imported drugs, coordination of State Drug Control organization etc.
CDSCO's regulatory framework for medical devices revolves around the Medical Device Rules, 2017 divided into 4 classes - A, B, C, and D, based on the associated risk level. The Pulse Oximeter falls under the Class C category demanding an MD9 license.
How to manufacture Pulse Oximeter
Manufacturing of Pulse Oximeter involves technical expertise & stringent quality control measures.
Fees for manufacturing license for Pulse Oximeter
An MD9 license is required for the production of the Pulse Oximeter, which costs INR 50,000 for the license and INR 1,000 per product.
Why is a Manufacturing License Necessary for Pulse Oximeter?
Having a manufacturing license for medical devices such as Pulse Oximeter is paramount. It not only ensures the maintenance of quality and safety but also instills faith among customers worldwide. Due to the critical role of Pulse Oximeters, even a small manufacturing defect can lead to serious implications. CDSCO license thus ensures strict quality control and standardization.
Steps to Obtain a CDSCO Manufacturing License for Pulse Oximeter
- All the necessary documentation like the Device Master File, Quality Management Certificate, Device Details, Site details etc., are required.
- Submit the application with all the necessary details and documents to CDSCO
- Obtain an acknowledgment receipt of the submitted application
- After documentation verification, obtain the CDSCO license
The exact procedure and documents requirement details can be found here
Frequently Asked Questions (FAQs)
Q1. What is the risk class of Pulse Oximeter as per the Medical Device Rules, 2017? A. As a critical monitoring device, Pulse Oximeter falls under the Class 'C' of the medical device risk classification as per the Medical Device Rules, 2017.
Q2. What license is needed to manufacture Pulse Oximeter? A. An MD9 license is required to manufacture Pulse Oximeter
Q3. What is the license fee for a Pulse Oximeter manufacturing license? A. The MD9 license fee is INR 50,000 and an additional INR 1,000 per product is applicable.
Q4. Who will issue the manufacturing license for a Pulse Oximeter? A. CDSCO HQ in New Delhi will issue the license for the manufacturing of Pulse Oximeter.
Q5. Is re-packaging of Pulse Oximeter considered manufacturing? A. Yes, repackaging of Pulse Oximeter is considered manufacturing under the provisions of the Drugs and Cosmetics Act. A valid MD9 license is required for the repackaging of Pulse Oximeter.
Conclusion
Navigating the complex regulatory landscape can be challenging. But you don't have to go it alone. The expert team at Pharmadocx Consultants is ready to assist you in obtaining your CDSCO manufacturing license quickly and efficiently. For a detailed consultation or assistance, you can reach out to them at "+91-7404557227" or drop an email to "[email protected]".
Whether you are a start-up or an established business, reaching out to Pharmadocx Consultants could be your first step towards achieving your manufacturing goals.