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CDSCO Manufacturing License for Dental Composite Resin Kit

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is a pivotal entity in the healthcare ecosystem of India. It shoulders significant responsibilities such as the regulation and approval of drugs, cosmetics, and medical devices, providing safe, efficacious, and quality medical products for public use. The organization plays a crucial role in ensuring compliance to procedures, undertaking surveillance, and setting the standards for manufacturing practices.

In the landscape of the healthcare industry, manufacturing licenses hold immense significance. It is a clear indicator of a medical device's compliance with set regulations, thus ensuring its safety and efficacy. The acquisition of a license is a testament to the manufacturer's commitment to delivering a quality product to the consumer.

Speaking of such devices, the Dental Composite Resin Kit, categorized under 'Dental', is a vital tool in the area of dental restoration. To understand more about the licensing of this device, refer to CDSCO's portal here.

What is Dental Composite Resin Kit?

A Dental Composite Resin Kit is a collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair. This kit contains various materials such as composite resin, etching solution, bonding agent, primer, prosthesis bonding agents, and unfilled resin sealant/coating agents. Not only that, but it may also come with disposable devices dedicated to application.

The kit is typically used in dental procedures involving restoration works and the installation or repair of dental prostheses. The Dental Composite Resin Kit does not, however, include non-resin based cement or dental prosthesis.

The Role of CDSCO in Medical Device Regulation

CDSCO has been instrumental in establishing and enforcing the regulatory framework for medical devices in India. Its mission has always been to protect and promote public health by ensuring the safety, efficacy, and quality of drugs, cosmetics, and diagnostic devices. It is committed to consistently enhancing its regulatory measures.

CDSCO's regulatory framework consists of specific guidelines and licenses, such as MD5 for Class A sterile and measuring devices and Class B devices, and MD9 for Class C and D devices.

How to manufacture Dental Composite Resin Kit

Fees for manufacturing license for Dental Composite Resin Kit

As the Dental Composite Resin Kit falls under Risk Class B, the appropriate manufacturing license needed is MD5. The fee structure for this license includes an initial cost of Rs. 5,000 for the license itself and an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Dental Composite Resin Kit?

As part of regulatory norms, obtaining a manufacturing license for a device like the Dental Composite Resin Kit is crucial. It is the gateway to ensuring quality and safety in production, thereby protecting consumers and patients from substandard products. Furthermore, it underlines the importance of regulatory compliance in the healthcare sector.

Steps to Obtain a CDSCO Manufacturing License for Dental Composite Resin Kit

Before starting the application process, it is essential to prepare certain documents like the Device Master File, a Quality Management Certificate, and detailed information about the device and the manufacturing site. The application process involves:

  1. Submission of required documents
  2. Undergoing inspection
  3. Mitigating discrepancies
  4. Receiving approval

Please note some challenges may arise during the licensing process, for which we provide professional consultation services here.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Dental Composite Resin Kit as per Medical Device Rules, 2017? The Dental Composite Resin Kit falls under Risk Class B as per the Medical Device Rules, 2017.

Q2. What license is needed to manufacture Dental Composite Resin Kit? The manufacturing license needed for the Dental Composite Resin Kit is MD5.

Q3. What is the fee for the MD5 license for Dental Composite Resin Kit? The fee for an MD5 license is Rs. 5,000 for the license itself and an additional Rs. 500 per product.

Q4. Who will issue the manufacturing license for Dental Composite Resin Kit? For Class B devices like the Dental Composite Resin Kit, the state FDA will issue the license.

Q5. Is repackaging of Dental Composite Resin Kit considered manufacturing? Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. The rules are extended to medical devices as well. Therefore, repackaging of Dental Composite Resin Kit is also considered manufacturing, requiring an MD5 license.

Conclusion

Navigating the process of obtaining a manufacturer's license for a medical device can be challenging. However, guidance is available. Feel free to reach out to our team at Pharmadocx Consultants for assistance at any stage of your licensing process. Visit us at Pharmadocx, call us on +91-7404557227, or send us a query at [email protected]. We are ready to help you simplify, accelerate, and successfully complete your licensing process.

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