Published on

CDSCO Manufacturing License for Carboxymethylcellulose sodium denture adhesive

Authors
  • avatar
    Name
    CDSCO Licenses Blog
    Twitter

Introduction

The Central Drugs Standard Control Organization (CDSCO), India's national regulatory authority for drugs, diagnostics, and medical devices, plays a crucial role in ensuring the safety, efficacy, and quality of medical products in the country. A key aspect of its role involves the granting of manufacturing licenses, a critical element in the medical device industry. This article offers an introduction to Carboxymethylcellulose Sodium Denture Adhesive, a Class B medical device, and lays out the licensing process as regulated by the CDSCO. For additional resources and to start your application process, visit the CDSCO's portal at CDSCO Portal.

What is Carboxymethylcellulose Sodium Denture Adhesive?

Carboxymethylcellulose Sodium Denture Adhesive is a compound primarily composed of carboxymethylcellulose sodium, usually between 40 and 100%. This adhesive holds a crucial role in dental care, particularly for individuals using removable dentures. It stabilizes the prosthetic by adhering the denture to the oral mucosa, and this enhanced stability increases user comfort and effectiveness.

The Role of CDSCO in Medical Device Regulation

The CDSCO, overseen by the Ministry of Health and Family Welfare, aims to regulate and monitor the standards of various health-related products, including medical devices like the Carboxymethylcellulose Sodium Denture Adhesive. The organization's history is marked by a constant commitment to enhancing public health, with a regulatory framework designed to ensure the safety, quality, and efficacy of medical devices.

Fees for manufacturing license for Carboxymethylcellulose Sodium Denture Adhesive

For Class B medical devices like the Carboxymethylcellulose Sodium Denture Adhesive, the necessary license is MD5. The fee for the MD5 license is Rs. 5,000, plus an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Carboxymethylcellulose Sodium Denture Adhesive?

Obtaining a manufacturing license is mandatory and ensures quality, safety in the production of medical devices. Regulatory compliance is of utmost importance in the healthcare sector to protect patients and consumers from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Carboxymethylcellulose Sodium Denture Adhesive

  1. Completing prerequisites and collecting documentation such as the Device Master File, Quality Management Certificate, Device Details, and Site details.
  2. The application process, which involves the submission of required documentation, followed by the approval process.
  3. Possible challenges that may arise and solutions to overcome them.

Note: For specifics on the MD5 license required for the Carboxymethylcellulose Sodium Denture Adhesive, view this article.

Frequently Asked Questions (FAQs)

Q1. What is risk class of Carboxymethylcellulose Sodium Denture Adhesive as per Medical Device Rules, 2017? The Carboxymethylcellulose Sodium Denture Adhesive falls under Risk Class B.

Q2. What license is needed to manufacture Carboxymethylcellulose Sodium Denture Adhesive? The license required for manufacturing the Carboxymethylcellulose Sodium Denture Adhesive is MD5.

Q3. What is the fees for MD5 license for Carboxymethylcellulose Sodium Denture Adhesive? The fee for the MD5 license is Rs. 5,000, plus an additional Rs. 500 per product.

Q4. Who will issue the manufacturing license for Carboxymethylcellulose Sodium Denture Adhesive? The manufacturing license for Class B devices like the Carboxymethylcellulose Sodium Denture Adhesive will be issued by the state FDA.

Q5. Is repackaging of Carboxymethylcellulose Sodium Denture Adhesive considered manufacturing? Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. As medical devices are also drugs, the repackaging of Carboxymethylcellulose Sodium Denture Adhesive is also considered manufacturing requiring a MD5 license.

Conclusion

Navigating the licensing process can be complex, which is why Pharmadocx Consultants are available for assistance regarding licensing processes. Visit our website or call us at +91-7404557227 or email to [email protected] for expert consultation. Our team is prepared to assist you throughout the process, ensuring a smooth pathway towards obtaining your manufacturing license.

cdsco import license in india banner
cdsco manufacturing license in india banner