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CDSCO Manufacturing License for Dental anaesthesia syringe, intraligamentary

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is one of the apex drug regulator bodies in India, governing the safety, efficacy, and quality of medical equipment and drugs in the country. Part of its key responsibility includes authorizing the marketing and manufacturing of medical devices, thus playing a crucial role in the protection of public health and safety.

In the realm of medical equipment, the manufacturing licenses play an important role as they validate the quality and safety of products. One of the medical devices that fall under CDSCO's purview is the Dental Anaesthesia Syringe, Intraligamentary, a key medical device used widely in dental procedures. More details about the manufacture and regulation of this device can be found on CDSCO's portal, which you can access here.

What is Dental Anaesthesia Syringe, Intraligamentary?

A Dental Anaesthesia Syringe, Intraligamentary is a manual dental instrument designed to inject an anaesthetic agent into the periodontal ligament or bone via a sterile needle attached to the device. Primarily used for local anesthesia in dental procedures, the syringe is hand-held and reusable.

The Role of CDSCO in Medical Device Regulation

The CDSCO plays a pivotal role in the regulation of medical devices in India, ensuring the safety and efficacy of devices through rigorous evaluation and monitoring. Offering a robust regulatory framework, CDSCO effectively supervises the manufacturing, import, and distribution of medical devices.

How to manufacture Dental Anaesthesia Syringe, Intraligamentary

To manufacture a Dental Anaesthesia Syringe, Intraligamentary, it is essential to have a clear understanding of the device's components and their assembly. Also, compliance with safety standards and CDSCO regulations is mandatory.

Fees for manufacturing license for Dental Anaesthesia Syringe, Intraligamentary

As the Dental Anaesthesia Syringe, Intraligamentary falls under risk class C, the fees for license MD9 is applicable, which is Rs. 50,000 for the license and Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Dental Anaesthesia Syringe, Intraligamentary

A manufacturing license is mandatory for the Dental Anaesthesia Syringe, Intraligamentary, as this license ensures compliance with necessary regulations and safety standards, ensuring the quality of the device. The license also prevents patients and consumers from being exposed to substandard and potentially hazardous products.

Steps to Obtain a CDSCO Manufacturing License for Dental Anaesthesia Syringe, Intraligamentary

The process to obtain a CDSCO manufacturing license involves the submission of the Device Master File, Quality Management Certificate, Device Details, Site details, among others. After the submission, the application undergoes an approval process. However, there can be challenges from time to time and understanding these challenges can help in overcoming them.

Frequently Asked Questions (FAQs)

  1. What is the risk class of Dental Anaesthesia Syringe, Intraligamentary as per Medical Device Rules, 2017?
    The Dental Anaesthesia Syringe, Intraligamentary falls under risk class C.

  2. What license is needed to manufacture Dental Anaesthesia Syringe, Intraligamentary?
    An MD9 license is needed to manufacture Dental Anaesthesia Syringe, Intraligamentary.

  3. What are the fees for an MD9 license for Dental Anaesthesia Syringe, Intraligamentary?
    The fees for the MD9 license are Rs. 50,000 for the license and Rs. 1,000 per product.

  4. Who will issue the manufacturing license for Dental Anaesthesia Syringe, Intraligamentary?
    The CDSCO HQ in New Delhi will issue the license.

  5. Is repackaging of Dental Anaesthesia Syringe, Intraligamentary considered manufacturing?
    Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of medical devices is also considered manufacturing. Therefore, repackaging of Dental Anaesthesia Syringe, Intraligamentary also requires an MD9 license.

Conclusion

The licensing process controls the safety and quality of medical devices. Despite its complexity, it is a necessary step in ensuring public health and safety. Understanding these procedures can be challenging, but professional assistance can simplify the process significantly. Consult Pharmadocx Consultants here, call "+91-7404557227", or email at [email protected] to get the expert help you need. For more information about MD9 license, you can visit this link.

Remember to uphold safety and integrity in all your medical device manufacturing endeavors. It not only ensures your compliance with the law but also your contribution to public health and welfare.

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