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CDSCO Manufacturing License for Dental Caries Removal Solution

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Introduction

Central Drugs Standard Control Organization (CDSCO) is India's pinnacle regulatory body entrusted with the task of safeguarding and promoting public health in India. Its comprehensive duties include laying out the standards for drugs, cosmetics, diagnostics, and more extensively medical devices. One of its primary responsibilities is the provision of manufacturing licenses for medical devices, a crucial element in the medical device industry.

We turn our focus to a medical device of particular significance--the Dental Caries Removal Solution. In the field of dentistry, it plays an irreplaceable role. This blog aims to impart essential knowledge about achieving a CDSCO manufacturing license for this device. For more extensive understanding and regular updates, please visit CDSCO’s official portal here.

What is Dental Caries Removal Solution?

A Dental Caries Removal Solution can be described as a fluid substance used in dental procedures and surgeries to identify and eliminate caries or dental decay from the affected tooth. Being an integral part of dentistry, it is extensively used in multiple procedures involving the diagnosis and removal of dental decay.

The Role of CDSCO in Medical Device Regulation

The CDSCO has a rich history dedicated to ensuring better healthcare for all citizens. Its regulatory framework is expressly structured to affirm the provision of safe and effective medical devices. It carries out its function by categorizing devices into varying classes based on their risk level, subsequently sanctioning the appropriate licenses.

How to manufacture Dental Caries Removal Solution

The manufacturing of Dental Caries Removal Solution involves carefully adhering to the prescribed guidelines and regulations put forth by the CDSCO.

Fees for manufacturing license for Dental Caries Removal Solution

As Dental Caries Removal Solution belongs to Class B of medical devices, the license required for its manufacturing is MD5. The licensing fee is Rs. 5,000, plus an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Dental Caries Removal Solution?

Acquiring a manufacturing license is not only mandatory but carries a broader importance. It ensures that the manufacturing process is supervised and adheres to standard practices. This way, quality and safety of the medical device are guaranteed. Moreover, it protects consumers and patients from substandard products, strengthening the credibility of the medical device industry.

Steps to Obtain a CDSCO Manufacturing License for Dental Caries Removal Solution

  1. Fulfilling pre-prerequisites, including documentation - Quality Management Certificate, Device Details, Device Master File, Site details.
  2. Submitting the application online.
  3. Following through the application process until approval.
  4. Being aware of common challenges in the process and preparing for them.

More about the MD5 license acquisition procedures can be obtained from this article.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Dental Caries Removal Solution as per Medical Device Rules, 2017?

The Dental Caries Removal Solution is classified under Class B.

Q2. What license is needed to manufacture Dental Caries Removal Solution?

The manufacture of Dental Caries Removal Solution requires an MD5 license.

Q3. What is the fee for the MD5 license for Dental Caries Removal Solution?

The fee for securing an MD5 license is Rs. 5,000 with an additional charge of Rs. 500 per product.

Q4. Who will issue the manufacturing license for Dental Caries Removal Solution?

For Class B devices like Dental Caries Removal Solution, the state FDA will issue the manufacturing license.

Q5. Is repackaging of Dental Caries Removal Solution considered manufacturing?

Yes. As per the Drugs and Cosmetics Act, repackaging of drugs is considered manufacturing and by further definitions, medical devices are also drugs. Therefore, repackaging of Dental Caries Removal Solution is considered manufacturing requiring an MD5 license.

Conclusion

If you find the process of obtaining a manufacturing license for your medical device a daunting task, don't hesitate to reach out for consultation or assistance. Pharmadocx Consultants are here to guide you throughout the process, ensuring your fruitful results. Visit Pharmadocx Consultants or call us at [+91-7404557227] or even drop an email at [[email protected]].

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