CDSCO Manufacturing License for Intraluminal artery stripper

Introduction

The Central Drugs Standard Control Organization, better known as CDSCO, carries significant importance in the medical sector. As India's foremost drug regulatory body, it ensures that patients across the nation have access to safe, effective, and high-quality medical products. From medicines, vaccines to medical devices, CDSCO plays a crucial role in regulating such goods to protect public health and safety.

Manufacturing licenses are a critical part of the medical device industry. Considering how vital medical devices are in diagnosing, preventing, and treating diseases, it's vital that these devices are manufactured in compliance with stringent regulations to ensure safety and efficacy.

One such device that holds prominence in the medical sector is the Intraluminal artery stripper. This article will shed light on the manufacturing licenses associated with the Intraluminal artery stripper and its importance in the health industry. For more details and official information, do visit the CDSCO's portal.

• What is Intraluminal artery stripper?
• The Role of CDSCO in Medical Device Regulation
• How to manufacture Intraluminal artery stripper
• Fees for manufacturing license for Intraluminal artery stripper
• Why is a Manufacturing License Necessary for Intraluminal artery stripper?
• Steps to Obtain a CDSCO Manufacturing License for Intraluminal artery stripper
• Frequently Asked Questions (FAQs)
• Conclusion

What is Intraluminal artery stripper?

The Intraluminal artery stripper is a lifeline for those suffering from atherosclerosis, a disease where plaque builds up inside the arteries. This medical device is used to perform endarterectomy, a surgical procedure that removes the plaque depositing from atherosclerotic arteries and restores normal blood flow.

Used primarily in cardiovascular procedures, it plays a vital role in preventing severe health conditions resulting from plaque buildup, such as heart attacks or strokes.

The Role of CDSCO in Medical Device Regulation

CDSCO plays an indispensable role in regulating the medical device industry in India. It ensures that all medical devices manufactured and marketed within the country comply with established quality and safety standards.

CDSCO has set up a comprehensive regulatory framework for medical devices, covering aspects from product classification and registration to post-market surveillance.

How to manufacture Intraluminal artery stripper

Being a Class B medical device as stated in the Medical Devices Rules, 2017, a manufacturing license is required for the production of Intraluminal artery strippers. Adherence to the manufacturing procedures laid out by CDSCO ensures the safety, efficacy and quality of these medical devices.

Fees for manufacturing license for Intraluminal artery stripper

The manufacturing license required for a Class B device like Intraluminal artery stripper is MD5. The license fee for this is Rs. 5,000 and an additional Rs. 500 is charged per product.

Why is a Manufacturing License Necessary for Intraluminal artery stripper?

Obtaining a manufacturing license is not merely a mandatory procedure; it plays essential roles in ensuring quality and safety in medical device production. Regulatory compliance in the healthcare sector is of utmost importance, and a valid license implies adherence to the same, guaranteeing the manufacturer's commitment to safety norms and standards.

Steps to Obtain a CDSCO Manufacturing License for Intraluminal artery stripper

Acquiring a CDSCO license involves a systematic process. Some prerequisites include; a Device Master File, a Quality Management Certificate, providing device details and site details. The application process includes four steps, namely; submission of application, review by authority, correction of deficiencies, and the grant of the license.

Frequently Asked Questions (FAQs)

1. What is the risk class of Intraluminal artery stripper as per Medical Device Rules, 2017?

   Intraluminal artery stripper is categorized as a Class B device under the Medical Device Rules, 2017.

2. What license is needed to manufacture Intraluminal artery stripper?

   To manufacture Intraluminal artery stripper, a Class B medical device, a MD5 license is required.

3. What is the fee for the MD5 license for Intraluminal artery stripper?

   The fee for an MD5 license for manufacturing Intraluminal artery stripper is Rs. 5,000, and there is an additional fee of Rs. 500 per product.

4. Who will issue a manufacturing license for Intraluminal artery stripper?

   The manufacturing license for Intraluminal artery stripper, a class B device, will be issued by the state FDA.

5. Is repackaging of Intraluminal artery stripper considered manufacturing?

   Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. By further definitions, medical devices are also drugs, and hence the repackaging of Intraluminal artery stripper is also considered manufacturing and requires a MD5 license.

Conclusion

Navigating the process of acquiring a manufacturing license can be challenging. It's important to have expert advice on your side to ensure compliance at each step. If you need consultation or assistance regarding the licensing process, feel free to reach out to Pharmadocx Consultants. You can directly contact them at "+91-7404557227" or email them at "[email protected]".