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CDSCO Manufacturing License for Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free

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Introduction

Central Drugs Standard Control Organization (CDSCO) is India's premier regulatory organization involved in standardizing and controlling the quality of drugs and medical devices in the country. Its core tasks include setting standards for drugs, cosmetics, and medical devices, testing the same for conformance, licensing, and monitoring the production and distribution of these items.

Manufacturing licenses play a crucial role in the medical device industry. They ensure that production is regulated and compliant with the predefined norms and standards, thus ensuring the best quality and safety standards. Taking our discussion further, let's talk about Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free, a dental device of significant importance in everyday life.

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What is Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free?

Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free is a dental adhesive compound intended to stabilize removable prostheses in the mouth, especially dentures. It ensures that the false teeth stay in place by sticking to the oral mucosal lining. Applied to the base of the denture, it assists in holding the denture securely in the mouth.

The Role of CDSCO in Medical Device Regulation

Founded with the mission of safeguarding public health in India, the CDSCO regulates the quality of all medical devices manufactured, imported, or used within the country. Their regulatory framework involves stringent quality checks, standards setting, licensing and overseeing the production and distribution of these medical devices.

Fees for manufacturing license for Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free

The fee for obtaining a MD5 manufacturing license for a Class B device like Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free is Rs. 5,000 with an additional per product charge of Rs. 500.

Why is a Manufacturing License Necessary for Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free?

Ensuring quality and safety in medical device production is paramount. A manufacturing license guarantees that the production process meets all the necessary regulatory norms. It aids in maintaining the highest standards of manufacturing while also protecting consumers and patients from potential low-quality or hazardous products. Regulatory compliance in the healthcare sector is critical, and a license serves as a testament to the commitment towards quality.

Steps to Obtain a CDSCO Manufacturing License for Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free

  1. Prepare the necessary documents, including the Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submit the application to CDSCO
  3. Track the application through the review process
  4. Address any issues or discrepancies caught during the review and get final approval.

Frequently Asked Questions (FAQs)

  1. Q. What is the risk class of Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free as per Medical Device Rules, 2017?

A. Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free falls under the Class B risk class.

  1. Q. What license is needed to manufacture Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free?

A. To manufacture this device, an MD5 license is required.

  1. Q. What is the fee for MD5 license for Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free?

A. The fee is Rs. 5,000 for the license and additional Rs. 500 per product.

  1. Q. Who will issue the manufacturing license for Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free?

A. For Class B devices like this, the state FDA will issue the license.

  1. Q. Is repackaging of Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free considered manufacturing?

A. Yes, under the Drugs and Cosmetics Act, repackaging of drugs, and by extension, medical devices, is considered manufacturing. Hence, repackaging this device also requires an MD5 license.

Conclusion

Navigating the licensing process can be challenging, and expert guidance can make this journey smoother. Feel free to reach out to Pharmadocx Consultants for consultation or assistance regarding the licensing process. Reach us at "+91-7404557227" or drop an email at "[email protected]".

For further information about the MD5 license, please refer to this article.

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