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CDSCO Manufacturing License for Anal fistula circular cutter

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a crucial role in safeguarding public health in India by ensuring the quality, efficacy, and safety of drugs and medical devices. Manufacturing licenses issued by CDSCO are a cornerstone of this mission, allowing only safe and effective medical devices to reach the market.

One such medical device of significant importance is the Anal fistula circular cutter, specifically intended for the circumferential resection of tissue to treat simple anal fistula in the field of Gastroenterology. For more information, visit CDSCO's portal here.

What is an Anal fistula circular cutter?

The Anal fistula circular cutter is a medical device manufactured under the risk class B. Its prime objective is to aid in the treatment of simple anal fistulas by accomplishing a circumferential resection of the tissue. The tool is widely utilized in numerous surgical procedures within the field of Gastroenterology.

The Role of CDSCO in Medical Device Regulation

CDSCO, stands as the Central Drug Authority and Regulatory Agency of India. The organization's principal objective is to promote public health by ensuring the quality and safety of medical devices. It achieves this via an evolving regulatory framework that categorizes devices based on their risk class (A being the lowest risk and D being the highest).

How to manufacture an Anal fistula circular cutter

The manufacturing process of an Anal fistula circular cutter entails rigorous product design, prototyping, testing, and validation phases, adhering to the appropriate safety and quality standards set by the CDSCO. It calls for strict hygiene and quality control to ensure patient safety and efficacy of the device.

Fees for manufacturing license for an Anal fistula circular cutter

For manufacturing a Class B device like an Anal fistula circular cutter, a MD5 license is required. The fees for MD5 license include Rs. 5,000 for the license and Rs. 500 per product.

Why is a Manufacturing License Necessary for an Anal fistula circular cutter?

A manufacturing license is essential to verify that the device is safe and efficacious. It ensures that the manufacturing processes and materials used align with the regulatory requirements, providing protection to consumers and patients from potentially substandard products. The license advocates for quality and safety in medical device production, reinforcing trust and credibility in healthcare.

Steps to Obtain a CDSCO Manufacturing License for an Anal fistula circular cutter

  1. Assembling the necessary documents such as the Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submit the application and all relevant documents to the appropriate authority.
  3. Undergo the scrutiny and approval process.
  4. Address and resolve any issues or challenges that arise during the approval process.

Frequently Asked Questions (FAQs)

Q. What is the risk class of an Anal fistula circular cutter as per Medical Device Rules, 2017?

A. The Anal fistula circular cutter falls under risk class B.

Q. What license is needed to manufacture an Anal fistula circular cutter?

A. The MD5 license is needed to manufacture an Anal fistula circular cutter.

Q. What is the fee for an MD5 license for an Anal fistula circular cutter?

A. The fee for the MD5 license is Rs. 5,000 along with an additional fee of Rs. 500 per product.

Q. Who will issue the manufacturing license for an Anal fistula circular cutter?

A. For Class B devices like the Anal fistula circular cutter, the state FDA will issue the license.

Q. Is repackaging of an Anal fistula circular cutter considered manufacturing?

A. Yes, repackaging is also considered manufacturing, and it thus requires an MD5 license.

For more details on MD5 license, visit here.

Conclusion

Navigating the process of obtaining a CDSCO manufacturing license can be a daunting task. The team at Pharmadocx Consultants provides expert guidance in handling the complexities of the application and approval process. For further consultation or assistance, contact Pharmadocx, call at +91-7404557227 or send an email to [email protected].

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