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CDSCO Manufacturing License for Dental anaesthesia injection kit

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is a pivotal authority in India that plays a significant role in ensuring the safety, efficacy, and quality of drugs and medical devices in the country. Its functions encompass the regulation of the quality of imported drugs, coordination of state licensing authorities, and granting approvals for clinical trials of new drugs. CDSCO is also responsible for establishing standards and regulatory measures for medical devices.

In the medical device industry, manufacturing licenses hold a considerable importance. They ensure that the devices produced adhere to the standards of quality and safety set by regulatory bodies, protecting consumers from substandard and potentially harmful products. Additionally, these licenses are a mandatory requirement for the production of medical devices in India. They serve as a testament to a manufacturer’s commitment to adhering to the highest industry standards.

In this blog post, we will delve into the particulars of the Dental anaesthesia injection kit, a device of high medical significance. To know more about CDSCO and its regulatory measures, you can visit the CDSCO's portal.

What is Dental anaesthesia injection kit?

The Dental anaesthesia injection kit is a collection of sterile devices specifically designed for the purpose of injecting dental anaesthetics into gingival tissue or the oral mucosa. It aids in preventing or reducing the risk of accidental needle-stick injury during restorative or surgical dental procedures. Dental anaesthesia injection kits are used commonly in dental care procedures and are an essential tool for any dental surgeon.

The Role of CDSCO in Medical Device Regulation

CDSCO has a long-standing mission to safeguard the health of the nation by establishing and enforcing standards of safety, effectiveness, and quality for drugs, devices, and biological products. The regulatory framework it uses for medical devices is comprehensive, integrating both national and international standards to ensure that the healthcare products available to the Indian public are of the highest quality.

How to manufacture Dental anaesthesia injection kit

Manufacture of such a crucial medical device like Dental anaesthesia injection kit demands the highest level of precision, care, and adherence to quality and safety protocols prescribed by the CDSCO.

Fees for manufacturing license for Dental anaesthesia injection kit

Under risk class B, the required license for manufacturing a Dental anaesthesia injection kit is MD5. The fees associated with obtaining an MD5 license are Rs. 5,000 for the license and an additional Rs. 500 per individual product.

Why is a Manufacturing License Necessary for Dental anaesthesia injection kit?

Obtaining a manufacturing license is mandatory for the production of this device. This ensures the quality and safety of the Dental anaesthesia injection kit that is crucial for patient care in dental procedures. Regulations in the healthcare sector are of paramount importance as they are devised to protect patients from substandard products. By complying with these regulations, manufacturers assure their commitment to providing only the finest and safest devices.

Steps to Obtain a CDSCO Manufacturing License for Dental anaesthesia injection kit

The pre-requisites for obtaining a manufacturing license include several important documents such as a Device Master File, Quality Management Certificate, Device Details, Site details, among others. The application process involves several steps, from submission of all necessary documents to its approval by the CDSCO. Making one's way through this process can invite certain challenges, which could potentially be overcome with expert guidance. To obtain a more detailed walkthrough on obtaining an MD5 license, reference this article.

Frequently Asked Questions (FAQs)

Q1. What is risk class of Dental anaesthesia injection kit as per Medical Device Rules, 2017?

The Dental anaesthesia injection kit falls under Risk Class B as per Medical Device Rules, 2017.

Q2. What license is needed to manufacture Dental anaesthesia injection kit?

To manufacture Dental anaesthesia injection kit, an MD5 license is required.

Q3. What is fees for MD5 license for Dental anaesthesia injection kit?

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

Q4. Who will issue manufacturing license for Dental anaesthesia injection kit?

For class B devices such as Dental anaesthesia injection kit, the state FDA will issue the license.

Q5. Is repackaging of Dental anaesthesia injection kit considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. By further definitions, medical devices are also considered drugs. The Medical Device Rules have been made under the provisions of the Drug Act only and hence repackaging of Dental anaesthesia injection kit is also considered manufacturing requiring an MD5 license.

Conclusion

Upon evaluating the essential functions CDSCO fulfills in upholding the standards of medical devices, it becomes apparent how significant these regulations are. For further consultation or assistance regarding the licensing process, you are invited to reach out to Pharmadocx Consultants, or call +91-7404557227 or send an email at [email protected]. Not only will Pharmadocx Consultants guide you through the process of obtaining the necessary licensing but also help you understand the CDSCO regulations better.

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