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CDSCO Manufacturing License for Nerve guide, bioabsorbable, synthetic

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is a principal regulatory body in India that functions under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. The key roles of CDSCO include regulatory control over the import of drugs, approval of new drugs and clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), and drafting of amendments to Acts and Rules.

Medical manufacturing licenses play a pivotal role in the production and distribution of medical devices. The licenses ensure that the devices adhere to the standards of safety, quality, and effectiveness. This assurance is crucial in the medical industry that works relentlessly to save lives and improve the quality of living.

I am introducing a highly significant medical device, the 'Nerve guide, bioabsorbable, synthetic'. This medical device has a pivotal role in peripheral nerve repair. Visit the CDSCO's portal here to learn more.

What is 'Nerve guide, bioabsorbable, synthetic'?

A nerve guide, bioabsorbable, synthetic is a medically implanted device that bridges the gap between discontinuous nerve stumps to allow for peripheral nerve regeneration. The nerve guide provides a protected pathway for the regrowing nerves.

The Nerve guide plays a significant part in surgeries involving peripheral nerve repair. It is particularly beneficial in nerve injuries with severed nerve stumps far apart that conventional surgical interventions cannot reconnect.

The Role of CDSCO in Medical Device Regulation

The CDSCO is the national regulatory authority for pharmaceuticals and medical devices in India. It ensures the quality, safety, and efficacy of medical devices through a regulatory framework that includes pre and post-market surveillance. The organization has laid out specific guidelines for each risk class (A, B, C, D) of medical devices.

How to manufacture 'Nerve guide, bioabsorbable, synthetic'

A complete understanding and adherence to CDSCO's regulatory guidelines are a prerequisite for manufacturing nerve guides. The manufacturing process must ensure the bioabsorbable and synthetic nature of the nerve guide. The quality of the manufacturing process directly relates to the efficacy of the nerve guide in facilitating peripheral nerve regeneration.

Fees for manufacturing license for 'Nerve guide, bioabsorbable, synthetic'

As the nerve guide is a class D medical device, the required license is MD9. The fee for the MD9 license is Rs. 50,000, and the fee for each product is Rs. 1,000.

Why is a Manufacturing License Necessary for 'Nerve guide, bioabsorbable, synthetic'?

A manufacturing license is mandatory for the production of medical devices. This mandatory requirement ensures integrity in the quality of medical devices, safety in their application, and compliance with regulatory standards. The license also protects patients from inferior or substandard products, reinforcing trust.

Steps to Obtain a CDSCO Manufacturing License for 'Nerve guide, bioabsorbable, synthetic'

Acquiring a CDSCO manufacturing license for nerve guides involves a defined process:

  1. Preparation with necessary prerequisites and documentation such as Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submission of the application to the regulatory authority.
  3. Adherence to the approval process, from inspection to compliance.
  4. Overcome challenges of the licensing process.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of 'Nerve guide, bioabsorbable, synthetic' as per Medical Device Rules, 2017? The risk class of 'Nerve guide, bioabsorbable, synthetic' is Class D.

Q2. What license is needed to manufacture 'Nerve guide, bioabsorbable, synthetic'? The MD9 license is needed to manufacture 'Nerve guide, bioabsorbable, synthetic'.

Q3. What is the fees for MD9 license for 'Nerve guide, bioabsorbable, synthetic'? The fee for the MD9 license is Rs. 50,000, and the fee per product is Rs. 1,000.

Q4. Who will issue the manufacturing license for 'Nerve guide, bioabsorbable, synthetic'? The CDSCO Headquarters in New Delhi will issue the license.

Q5. Is repackaging of 'Nerve guide, bioabsorbable, synthetic' considered manufacturing? Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Since medical devices are also drugs under the Act, repackaging of 'Nerve guide, bioabsorbable, synthetic' is also considered manufacturing requiring an MD9 license.

Conclusion

Navigating the licensing procedure for manufacturing nerve guides can be a challenging task. It is recommended to seek assistance for the procedure. At Pharmadocx Consultants, we provide expert consultation and assistance for medical device licensing. Feel free to reach out to us at Pharmadocx or call us at +91-7404557227 . You can also email us at [email protected].

For readers interested in learning more about MD9 licenses, you can explore this article here.

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