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CDSCO Manufacturing License for Endodontic Sealer

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is at the epicenter of India's healthcare industry, overseeing various facets associated with drugs, cosmetics and medical devices. The key functions of CDSCO include approving new drugs, conducting clinical trials, setting standards for pharmaceuticals, and regulating medical devices in the country. Importantly, it grants manufacturing licenses needed to create a diverse range of medical devices, including the Endodontic Sealer.

Manufacturing licenses play a pivotal role in the medical device industry as they assure quality control, safety standards, and regulatory compliance. The Endodontic Sealer, a dental device of paramount importance, falls under these regulations and requires proper licensing for its manufacture. To get additional information about the processes and procedures, you can visit the CDSCO's portal.

What is Endodontic Sealer?

An Endodontic Sealer is a dental material used to fill and seal all pathways between the root canal and external surfaces of the tooth. This essentially means it is used for the permanent obturation of the root canal, an integral part of dental procedures like root filling, repair of root perforations, pulp capping and apexification.

The Role of CDSCO in Medical Device Regulation

The CDSCO’s mission is to safeguard and enhance public health in India by assuring the safety, efficacy and quality of drugs, cosmetics, and medical devices. One of their prime functions is to regulate medical devices in India, and the Endodontic Sealer is no exception.

How to manufacture Endodontic Sealer

In short, the manufacturing process includes acquiring raw materials, producing the sealer, testing its quality, packaging, and finally, distributing it in the market. All these steps have to follow the guidelines laid by CDSCO and require a manufacturing license.

Fees for manufacturing license for Endodontic Sealer

For Class B medical devices like the Endodontic Sealer, an MD5 license is required. The fees for an MD5 license are Rs. 5,000 for the license and Rs. 500 per product.

Why is a Manufacturing License Necessary for Endodontic Sealer?

Acquiring a manufacturing license is mandatory by law. It ensures quality control, safety in medical device production and protects consumers and patients from substandard products. Above all, it marks regulatory compliance in the healthcare sector.

Steps to Obtain a CDSCO Manufacturing License for Endodontic Sealer

  1. Prepare the prerequisites documents including Device Master File, Quality Management Certificate, Device Details, Site details etc.
  2. Apply for the license online through the CDSCO's portal.
  3. Follow the instructions and submit the necessary documents.
  4. Awaiting approval which could take a minimum of 3 months.

Frequently Asked Questions (FAQs)

Q1. What is risk class of Endodontic Sealer as per Medical Device Rules, 2017?

Endodontic Sealer is classified as a Class B medical device.

Q2. What license in needed to manufacture Endodontic Sealer?

To manufacture Endodontic Sealer, an MD5 license is required.

Q3. What is fees for MD5 license for Endodontic Sealer?

The fees for the MD5 license for Endodontic Sealer are Rs. 5,000 for the license and Rs. 500 per product.

Q4. Who will issue manufacturing license for Endodontic Sealer?

For Class B devices like Endodontic Sealer, the state FDA will issue the license.

Q5. Is repackaging of Endodontic Sealer considered manufacturing?

Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by further definitions, medical devices are also drugs. Hence, repackaging of Endodontic Sealer also is considered manufacturing requiring a license on MD5.

Conclusion

The licensing process for manufacturing an Endodontic Sealer is a meticulous one, however, the assistance of experienced professionals can smoothen the path. Feel free to reach out to Pharmadocx Consultants or call on +91-7404557227 or simply email to [email protected] for any queries or assistance regarding the licensing process.

If you need more information about the MD5 license, you can check this comprehensive article - MD5 License for Class A & B Medical Devices.

Remember, ensuring regulatory compliance is not just a legal obligation, but it's also a commitment to quality and safety in the healthcare industry.

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