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CDSCO Manufacturing License for Pulmonary resuscitator
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- CDSCO Licenses Blog
Introduction
The Central Drugs Standard Control Organization, also known as CDSCO, is a foremost regulatory body of India with a core mandate of safeguarding public health through the regulatory supervision of food, drugs, cosmetics and medical devices. As the apex national authority overseeing the approval of manufacturing facilities, import, conduct of clinical trials, laying down standards, and control over the quality of medical devices, it plays a pivotal role in the Indian medical landscape.
One key component of their responsibility includes issuing manufacturing licenses essential for the production of medical devices. The importance of these permits can't be overstated in the medical device industry.
This blog will focus on the Pulmonary Resuscitator, an integral medical device used in providing life-saving support and ventilation for patients struggling with breathing difficulties or not breathing at all. Please visit CDSCO's portal for more relevant information.
- What is a Pulmonary Resuscitator?
- The Role of CDSCO in Medical Device Regulation
- How to manufacture Pulmonary Resuscitator
- Fees for manufacturing license for Pulmonary Resuscitator
- Why is a Manufacturing License Necessary for a Pulmonary Resuscitator?
- Steps to Obtain a CDSCO Manufacturing License for a Pulmonary Resuscitator
- Frequently Asked Questions (FAQs)
- Conclusion
What is a Pulmonary Resuscitator?
A Pulmonary Resuscitator is a manually operated medical device specifically designed to provide or assist ventilation in patients who are apnoeic or those exhibiting inadequate respiration. This device has a life-saving role in medical emergencies when patients require assistance in normal breathing or resuscitation due to various reasons, including unconsciousness, cardiac arrest, or anesthetic procedures.
The Role of CDSCO in Medical Device Regulation
Established under the Drugs and Cosmetics Act, 1940, the Central Drugs Standard Control Organization, operates under the Ministry of Health and Family Welfare, Government of India. CDSCO guards the health of Indian citizens by ensuring the quality, safety and efficacy of medical devices, based on scientific excellence and on international benchmarks.
To manufacture a device like Pulmonary Resuscitator, it's absolutely critical to follow the regulatory framework set by CDSCO to ensure that its manufacturing adheres to the highest standard of safety and quality.
How to manufacture Pulmonary Resuscitator
The manufacturing of a Pulmonary Resuscitator requires adherence to the specifications that ensure the safety, efficiency, and reliability of the device. High-quality materials, skilled craftsmanship and engineering, rigorous testing, and a clean, sterile manufacturing environment are critical components of the manufacturing process.
Fees for manufacturing license for Pulmonary Resuscitator
Considering that a Pulmonary Resuscitator falls under risk class C, it requires the MD9 manufacturing license. The licensing fee is Rs. 50,000 for the license itself and Rs. 1,000 per product.
Why is a Manufacturing License Necessary for a Pulmonary Resuscitator?
Securing a manufacturing license is not just a legal obligatory, but also a measure that ensures coherence with set standards, quality, and safety in medical device production. This mandate emphasizes the significance of regulatory compliance in healthcare to shield consumers and patients from substandard products and safeguard public health.
Steps to Obtain a CDSCO Manufacturing License for a Pulmonary Resuscitator
To obtain a CDSCO Manufacturing License, needed documents include the Device Master File, Quality Management Certificate, Device Details, Site details, etc. The application process involves submission, review, potential correction, and eventual approval. Challenges can arise in the application process but with proper guidance and clarity, these can be skilfully navigated.
Frequently Asked Questions (FAQs)
Q. What is the risk class of a Pulmonary Resuscitator as per Medical Device Rules, 2017?
The Pulmonary Resuscitator falls under risk class C.
Q. What license is needed to manufacture a Pulmonary Resuscitator?
The MD9 license is required to manufacture a Pulmonary Resuscitator.
Q. What is the fees for an MD9 license for a Pulmonary Resuscitator?
The fee for the MD9 license for a Pulmonary Resuscitator is Rs. 50,000 for the license itself and Rs. 1,000 per product.
Q. Who will issue the manufacturing license for a Pulmonary Resuscitator?
For class C devices such as a Pulmonary Resuscitator, the license is issued by the CDSCO HQ in New Delhi.
Q. Is repackaging of a Pulmonary Resuscitator considered manufacturing?
Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is deemed manufacturing and, by further extension, medical devices are too regarded as drugs. Medical Device Rules have been made under the provisions of Drug Act alone and hence repackaging of a Pulmonary Resuscitator is also regarded as manufacturing necessitating an MD9 license.
Conclusion
Procuring a CDSCO Medical Device License can be a complex task, especially bringing together the requisite paperwork, undergoing rigorous controls, and meeting quality and safety standards. Professional guidance is not just a luxury but a necessity. Feel free to reach out for a consultation or for assistance with the licensing process. Drop us an email at [email protected], call us at ++91-7404557227, or visit Pharmadocx Consultants for comprehensive consulting services in compliance with CDSCO regulations.
For further understanding about MD9 manufacturing license you can refer to this article here. With our extensive experience in the field, we guarantee professional assistance, simplifying the complex, and ensuring smooth procedures. Together, we can make healthcare safer, better, and more efficient.
