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CDSCO Manufacturing License for Dental crown/bridge resin, temporary

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is a prominent regulatory authority in India responsible for ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices available to Indian consumers. One of the lesser-known but incredibly significant functions of CDSCO is the regulation and monitoring of the medical device industry, especially the issuance of manufacturing licenses. This fundamental process contributes extensively to maintaining high-quality standards and patient safety in the healthcare sector.

Our focus in this article is the manufacturing licence procedure for Dental Crown/Bridge Resin, Temporary, a Class B medical device used widely in dental healthcare for the fabrication of crowns and bridges. CDSCO's portal provides comprehensive details of all medical devices, regulations, and licensing procedures.

What is Dental Crown/Bridge Resin, Temporary?

A Dental Crown or Bridge Resin, Temporary, is a material specifically designed to manufacture intermediate or temporary dental crowns and bridges. These are typically used during dental prosthetic treatments, as a temporary restoration while the permanent prostheses (crowns or bridges) are being fabricated.

These temporary dental materials play a vital role in preserving tooth structure, managing sensitivity and discomfort, and maintaining aesthetics and function until the permanent restoration's placement.

The Role of CDSCO in Medical Device Regulation

CDSCO has a critical role in shaping India's healthcare landscape through the regulation of drugs, cosmetics, and medical devices. Its mission is to safeguard and enhance public health by assuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices.

CDSCO's regulatory framework for medical devices categorises them into four classes (A, B, C, D) based on the level of potential risk associated with their use. Class A devices represent the lowest risk, and Class D the highest.

How to manufacture Dental Crown/Bridge Resin, Temporary

The manufacturing process of Dental Crown/Bridge Resin, Temporary involves various steps, from raw material procurement to the final packaging. Manufacturers must comply with the Medical Device Rules, 2017, implemented by CDSCO and obtain the necessary manufacturing license to ensure quality, safety, and efficacy.

Fees for manufacturing license for Dental Crown/Bridge Resin, Temporary

As a Class B medical device, the manufacturing license required for Dental Crown/Bridge Resin, Temporary is MD5. The fee for this license is Rs. 5,000, along with Rs. 500 per product.

Why is a Manufacturing License Necessary for Dental Crown/Bridge Resin, Temporary?

It is mandatory for manufacturers to acquire a license to ensure the production of safe and high-quality devices. Obtaining a manufacturing license for a medical device like Dental Crown/Bridge Resin, Temporary helps maintain and control the product's quality and safety, fostering trust in the product among consumers and patients. It illustrates the manufacturer's commitment to regulatory compliance, further contributing to the credibility of the healthcare sector and protecting consumers from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Dental Crown/Bridge Resin, Temporary

Obtaining a CDSCO manufacturing license involves the following basic steps:

  1. Ensure pre-requisites: Having a Device Master File, Quality Management Certificate, product details, and site details.
  2. Application submission: A completed application form should be submitted along with required documents and the prescribed fee.
  3. Review and feedback: After the application's review, any discrepancies found should be addressed and corrected.
  4. Approval: Upon scrutiny of the revised application, the license is granted if all guidelines and regulations are met.

Frequently Asked Questions (FAQs)

Q.1. What is risk class of Dental Crown/Bridge Resin, Temporary as per Medical Device Rules, 2017?

  • Dental Crown/Bridge Resin, Temporary falls under Class B according to the Medical Device Rules, 2017.

Q.2. What license is needed to manufacture Dental Crown/Bridge Resin, Temporary?

  • The required license for manufacturing Dental Crown/Bridge Resin, Temporary is MD5.

Q.3. What is the fees for MD5 license for Dental Crown/Bridge Resin, Temporary?

  • The fee for an MD5 license is Rs. 5,000 and Rs. 500 per product.

Q.4. Who will issue manufacturing license for Dental Crown/Bridge Resin, Temporary?

  • For Class B devices like Dental Crown/Bridge Resin, Temporary, the state FDA will issue the license.

Q.5. Is repackaging of Dental Crown/Bridge Resin, Temporary considered manufacturing?

  • Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs and by further extension, medical devices, is considered manufacturing. Hence repackaging of Dental Crown/Bridge Resin, Temporary also requires an MD5 license.

Conclusion

We hope this blog provided valuable insights into the CDSCO manufacturing license for Class B medical devices like Dental Crown/Bridge Resin, Temporary. If you need expert consultation regarding this licensing process, feel free to reach out to Pharmadocx Consultants at +91-7404557227 or send an email at [email protected]. For more detailed information on MD5 license, visit this link. We're here to assist you with your every need.

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