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CDSCO Manufacturing License for Nerve guide, bioabsorbable, animal-derived

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for pharmaceuticals and medical devices in India. Its mandate includes ensuring the quality of medical devices, guaranteeing safety for end-users and streamlining the compliance processes for manufacturers.

Manufacturing licenses play a critical role in the medical device industry as they provide a quality assurance guarantee for both the manufacturers and the users. Without them, standardization and quality control would be highly challenging, leaving the industry vulnerable to a raft of safety issues.

In this blog post, we focus on one particular medical device, the Nerve Guide, which is bioabsorbable and animal-derived. This medical device plays a significant role in the neurological field of medicine due to its function of aiding peripheral nerve regeneration. CDSCO's official portal provides abundant regulatory information and updates on this and other medical devices.

What is Nerve Guide, Bioabsorbable, Animal-Derived?

A Nerve Guide is a collagen matrix material designed to create a tunnel between proximal and distal nerve stumps, enabling the regeneration of a discontinuous peripheral nerve.

The use of Nerve Guides is commonly applied in the medical field to assist patients with peripheral nerve injuries. They provide a defined, isolated path for regenerating nerve fibers, facilitating nerve repair and restoration of nerve function.

The Role of CDSCO in Medical Device Regulation

CDSCO's mission is to safeguard and enhance the public health by ensuring the safety, efficacy and quality of medical devices including Nerve Guides. It achieves its role through a comprehensive regulatory framework which covers manufacturing, clinical trials, import and sale of medical devices.

How to Manufacture Nerve Guide, Bioabsorbable, Animal-Derived

The manufacturing process of a Nerve Guide requires adherence to set guidelines and regulations. Due to their Class D risk level, Nerve Guides need to be manufactured under a MD9 license issued by the CDSCO.

Fees for Manufacturing License for Nerve Guide, Bioabsorbable, Animal-Derived

Manufacturing fees for a Class D device such as the Nerve Guide include a licensing fee of Rs. 50,000 and a product fee of Rs. 1,000.

Why is a Manufacturing License Necessary for Nerve Guide, Bioabsorbable, Animal-Derived?

A manufacturing license is mandatory for all medical devices, including the Nerve Guide. The license is proof of adherence to the quality and safety standards set by regulatory authorities. It ensures a strong commitment to regulatory compliance, protecting consumers, patients and manufacturers from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Nerve Guide, Bioabsorbable, Animal-Derived

  1. Ensure you have all the prerequisite documentation, including a Device Master File, Quality Management Certificate, Device Details, and Site details, among others.
  2. Submit your application to the appropriate regulatory authority for review and approval.
  3. Be prepared for any potential challenges that might arise and be ready with solutions.
  4. Follow up on your application regularly to ensure its swift approval.

Frequently Asked Questions (FAQs)

  1. What is the risk class of a Nerve Guide, Bioabsorbable, Animal-Derived as per Medical Device Rules, 2017? The Nerve Guide belongs to Class D, the highest risk class.

  2. What license is needed to manufacture a Nerve Guide, Bioabsorbable, Animal-Derived? Since the Nerve Guide is a Class D device, it requires an MD9 license for manufacturing.

  3. What is the fee for an MD9 license for a Nerve Guide, Bioabsorbable, Animal-Derived? The fees for an MD9 license include a license fee of Rs. 50,000 and a product fee of Rs. 1,000.

  4. Who will issue the manufacturing license for a Nerve Guide? The CDSCO HQ in New Delhi will issue the manufacturing license for a Nerve Guide, Bioabsorbable, Animal-Derived.

  5. Is repackaging of a Nerve Guide considered manufacturing? Yes, according to the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs and, by extension, medical devices is considered manufacturing. Therefore, repackaging a Nerve Guide also requires an MD9 license.

For detailed information on the MD9 manufacturing license, you may visit this article.

Conclusion

The process of obtaining a manufacturing license for medical devices like the Nerve Guide, Bioabsorbable, Animal-Derived can be complex and challenging. Engaging a seasoned consultant, like Pharmadocx Consultants, can facilitate this process by providing top-tier expert advice.

Feel free to reach out for consultation or assistance regarding the licensing process through their website, reach them by phone at +91-7404557227, or send an email to [email protected] for more information.

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