CDSCO Manufacturing License for Aneurysm clip.

Introduction

The medical devices sector is a highly regulated one, particularly in a nation like India. At the heart of the regulatory framework is the Central Drugs Standard Control Organization (CDSCO), which is dedicated to protecting the public's health and well-being by ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices. The CDSCO conducts these functions through a comprehensive set of procedures, and one of these is the issuance of manufacturing licenses. These licenses are crucial in the medical device industry as they ensure that manufacturers adhere to stringent quality and safety standards.

Next, we delve into a critical medical device – the Aneurysm clip – its definition, use, and what manufacturing license is needed to produce it. It's significant in the healthcare sector as it plays a vital role in treating a condition that could potentially lead to severe health implications if not addressed. Curious to know more? Let’s dive right in! For additional information, head to CDSCO's portal here.

• What is an Aneurysm Clip?
• The Role of CDSCO in Medical Device Regulation
• How to manufacture an Aneurysm Clip
• Fees for Manufacturing License for an Aneurysm Clip
• Why is a Manufacturing License Necessary for an Aneurysm Clip?
• Steps to Obtain a CDSCO Manufacturing License for an Aneurysm Clip
• Frequently Asked Questions (FAQs)
• Conclusion

What is an Aneurysm Clip?

Aneurysm Clip, as the name suggests, is used to occlude an intracranial aneurysm – a balloon-like sac formed on a blood vessel, to prevent it from bleeding or bursting. These clips have a key role in medical procedures which require the precise and secure occlusion of blood vessels, to prevent hemorrhagic complications. Their use is most common in neurosurgery, where they're crucial to the treatment and management of brain aneurysms.

The Role of CDSCO in Medical Device Regulation

CDSCO, since its inception, has been endeavoring to continually evolve the regulatory framework for medical devices. It aims at enabling cutting edge medical devices to be made available to the citizens at the earliest and at the same time ensuring the safety and efficacy of the devices. Through a rigorous regulatory framework, CDSCO scrutinizes every step from the manufacturing to the post-marketing phase of a medical device.

How to manufacture an Aneurysm Clip

Manufacturing an aneurysm clip require an MD9 License and adherence to strict regulations. The manufacturing process must meet the highest standards to ensure the safety of patients and the effectiveness of the device. To learn more about the MD9 license process, you can read here

Fees for Manufacturing License for an Aneurysm Clip

The fee for the MD9 license necessary for manufacturing aneurysm clips is Rs.50,000 for the license and Rs.1,000 per product.

Why is a Manufacturing License Necessary for an Aneurysm Clip?

Manufacturing licenses are a regulatory requirement and ensure that devices produced meet the highest quality and safety standards. Regulatory compliance is not only a legal duty, but it is also imperative in safeguarding the reputation of a manufacturer, ensuring trust among consumers and healthcare professionals. Licenses protect patients and consumers from potential harm by ensuring only quality products are in the market.

Steps to Obtain a CDSCO Manufacturing License for an Aneurysm Clip

1. Prepare essential documentation including Device Master File, Quality Management Certificate, Device Details, Site details, and so on.
2. Submit the complete application package to the relevant authority
3. Wait for review and inspection from the regulatory agency
4. Upon successful review and inspection, the license is issued

Frequently Asked Questions (FAQs)

1. Q: What is the risk class of an Aneurysm Clip as per Medical Device Rules, 2017?

   A: The Aneurysm Clip is classified as a Class D medical device.

2. Q: What license is needed to manufacture an Aneurysm Clip?

   A: To manufacture an Aneurysm Clip, an MD9 License is required.

3. Q: What is the fee for the MD9 license for an Aneurysm Clip?

   A: The fee for the MD9 license is Rs. 50,000 for the license and Rs.1,000 per product.

4. Q: Who will issue the manufacturing license for an Aneurysm Clip?

   A: The CDSCO HQ in New Delhi will issue the license for Class D devices like the Aneurysm Clip.

5. Q: Is repackaging of an Aneurysm Clip considered manufacturing?

   A: Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and hence repackaging of an Aneurysm Clip is also considered manufacturing requiring an MD9 license.

Conclusion

Acquiring a manufacturing license can be an intricate process, requiring expert knowledge and meticulous attention to detail which is we are here to offer. Any queries or need for assistance related to the licensing process should reach out to Pharmadocx Consultants through this link, or call "+91-7404557227" or email at "[email protected]". The goal is to ensure that your medical device manufacturing journey is smooth, compliant, and successful.