Published on

CDSCO Manufacturing License for Zinc phosphate dental cement

Authors
  • avatar
    Name
    CDSCO Licenses Blog
    Twitter

Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a crucial role in ensuring the quality and safety of medical devices. Its robust regulatory functions include setting standards, granting licenses, and overseeing the manufacturing process. The goal: to safeguard public health by ensuring the quality, efficacy, and safety of devices. This is particularly important in the case of medical devices like zinc phosphate dental cement, which are pivotal in dental treatments. For more details on CDSCO and its role, feel free to visit CDSCO's portal

What is Zinc Phosphate Dental Cement?

Zinc phosphate dental cement is a non-sterile substance intended for professional use as a dental cement and/or direct dental restorative material. The principal constituent of this cement is Zinc Oxide (ZnO), which hardens upon reacting with an aqueous phosphoric acid solution. The result is a biocompatible cement that bonds well with enamel and dentin.

The Role of CDSCO in Medical Device Regulation

CDSCO, India's principal regulatory body for ensuring the safe and effective use of drugs and medical devices, has a deep commitment to public health. With its overarching framework for medical device regulation, CDSCO ensures the rigorous and comprehensive evaluation of all medical devices, including dental cements, that enter the Indian market.

How to Manufacture Zinc Phosphate Dental Cement?

The manufacturing of Zinc Phosphate Dental Cement requires a precise process in which an oxide powder and an aqueous solution of phosphoric acid undergo a hardening reaction. This process must be done under strict regulatory compliance to ensure the safety and efficacy of the final product.

Fees for Manufacturing License for Zinc Phosphate Dental Cement

For devices falling under Class B, such as Zinc Phosphate Dental Cement, an MD5 license is required. The fees for MD5 are Rs. 5,000 for the license and Rs. 500 per product. More information on the MD5 license can be found at here

Why is a Manufacturing License Necessary for Zinc Phosphate Dental Cement?

First, acquiring a manufacturing license is a legal obligation. Beyond that, the license signifies that the manufacturer upholds CDSCO's stringent quality and safety standards, thereby preventing the production and sale of substandard products. In the healthcare sector, regulatory compliance is not simply a matter of legal necessity—it has direct implications for patient safety and the overall efficacy of medical treatments.

Steps to Obtain a CDSCO Manufacturing License for Zinc Phosphate Dental Cement

  1. Prepare the required documents, including the Device Master File, Quality Management Certificate, and complete details of the device and manufacturing site.
  2. Submit the application with all necessary documentation.
  3. Await the evaluation process by the concerned authorities.
  4. Upon successful evaluation and fulfilment of all criteria, obtain the license.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Zinc Phosphate Dental Cement as per Medical Device Rules, 2017? Zinc Phosphate Dental Cement falls under Risk Class B as per Medical Device Rules, 2017.

Q2. What license is needed to manufacture Zinc Phosphate Dental Cement? The MD5 license is required to manufacture Zinc Phosphate Dental Cement.

Q3. What is the fees for the MD5 license for Zinc Phosphate Dental Cement? The fees for the MD5 license are Rs. 5,000 for the license and Rs. 500 per product.

Q4. Who will issue the manufacturing license for Zinc Phosphate Dental Cement? The state FDA will issue the manufacturing license for Zinc Phosphate Dental Cement.

Q5. Is repackaging of Zinc Phosphate Dental Cement considered manufacturing? Yes, as per the Drugs and Cosmetics Act's definition, repackaging of drugs, which includes medical devices like Zinc Phosphate Dental Cement, is considered manufacturing. Thus, a license is required.

Conclusion

Obtaining a manufacturing license can often be a cumbersome process, involving a significant understanding of the regulations and their application. Pharmadocx Consultants is here to help guide you through this process and assist in any way possible. You can reach out to us for consultation through our website, or call us at "+91-7404557227" or email us at "[email protected]".

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