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CDSCO Manufacturing License for Dental Root Surface Conditioner

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Introduction

The Central Drugs Standard Control Organization (CDSCO), India’s regulatory authority for pharmaceuticals and medical devices, plays a pivotal role in ensuring public health safety. The organization's primary responsibilities include approving drugs, overseeing clinical trials, and setting quality standards for medical devices. In the Indian medical device industry, obtaining a manufacturing license is vital to ensure the production of safe, effective, and high-quality devices.

The medical device in focus for this post is the Dental Root Surface Conditioner, an indispensable tool in modern dentistry. As we delve into the topic, we encourage you to explore more about this device and the CDSCO's role in regulating its manufacture through their official portal, here

What is Dental Root Surface Conditioner?

A Dental Root Surface Conditioner is a specialized product used for the debridement and cleaning of dental root canals. It serves a crucial function in dentistry, aiding in the chemical breakdown of pulp soft tissue, thereby facilitating the process of root canal treatment. Dentists commonly utilize this device during endodontic procedures to ensure thorough cleaning and disinfection of the root canal system.

The Role of CDSCO in Medical Device Regulation

Since its formation, the CDSCO's mission has been to afford a robust regulatory framework for pharmaceuticals and medical devices, ensuring quality, efficacy, and safety. Their regulatory model for medical devices encompasses defining risk classes, mandating manufacturing licenses, and setting standards for quality control.

How to manufacture Dental Root Surface Conditioner

The production of the Dental Root Surface Conditioner aligns with the regulations set forth by the CDSCO. Medical device manufacturers should comply with established guidelines and quality controls to assure safety and effectiveness.

Fees for manufacturing license for Dental Root Surface Conditioner

As per the risk classification of the Dental Root Surface Conditioner (Class B), the required license is MD5. The fees for obtaining MD5 are as follows: Rs. 5,000 for the license and Rs. 500 per product. To learn more about MD5 license, read here

Why is a Manufacturing License Necessary for Dental Root Surface Conditioner?

Obtaining a manufacturing license is a mandatory requirement as stipulated by the CDSCO. The license is an assurance of quality and safety in the production of medical devices. It upholds regulatory compliance in the healthcare sector and guards consumers and patients against substandard products.

Steps to Obtain a CDSCO Manufacturing License for Dental Root Surface Conditioner

  1. Gather necessary documents such as the Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submit the application along with the necessary fees.
  3. Await approval from CDSCO.
  4. Tackle any challenges that arise promptly and effectively.

Frequently Asked Questions (FAQs)

Q. What is the risk class of the Dental Root Surface Conditioner as per Medical Device Rules, 2017?
The Dental Root Surface Conditioner falls under Risk Class B.

Q. What license is needed to manufacture the Dental Root Surface Conditioner?
The MD5 license is needed to manufacture the Dental Root Surface Conditioner.

Q. What is the fee for the MD5 license for the Dental Root Surface Conditioner?
The fee for the MD5 license is Rs. 5,000 and Rs. 500 per product.

Q. Who will issue the manufacturing license for the Dental Root Surface Conditioner?
The state FDA will issue the MD5 license for the manufacture of this device.

Q. Is repackaging of the Dental Root Surface Conditioner considered manufacturing?
Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and further, medical devices are also drugs. Hence, repackaging of the Dental Root Surface Conditioner is considered manufacturing requiring a license on MD5.

Conclusion

Successfully navigating the licensing process can be a complex task. Our team at Pharmadocx Consultants are well-equipped to assist you with consultation or any assistance regarding the licensing process. We invite you to reach out for a consultation by visiting our website here, calling us on +91-7404557227, or emailing us at [email protected]. Let us guide you through the procedures, ensuring your compliance with the regulatory requirements of the CDSCO.

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