CDSCO Manufacturing License for Dental anaesthesia syringe, single-use

Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's pivotal regulatory body, monitoring the safety, efficacy and quality of pharmaceuticals, medical devices, and cosmetics. CDSCO, under the jurisdiction of the Ministry of Health and Family Welfare, ensures that these products meet the required standards by granting licenses related to manufacturing, import, clinical trials and marketing.

In the ever-evolving medical device industry, obtaining a manufacturing license ensures a device's quality, safety, and efficacy. For instance, the Dental Anaesthesia Syringe, Single-Use, a Class B risk medical device, plays a significant role in the healthcare sector. Understanding its manufacturing process and licensing are crucial parts of ensuring the health and safety of patients. For more details, visit the CDSCO's portal here.

• What is a Dental Anaesthesia Syringe, Single-Use?
• The Role of CDSCO in Medical Device Regulation
• How to manufacture a Dental Anaesthesia Syringe, Single-Use
• Fees for manufacturing license for Dental Anaesthesia Syringe, Single-Use
• Why is a Manufacturing License Necessary for a Dental Anaesthesia Syringe, Single-Use?
• Steps to Obtain a CDSCO Manufacturing License for a Dental Anaesthesia Syringe, Single-Use
• Frequently Asked Questions (FAQs)
• Conclusion

What is a Dental Anaesthesia Syringe, Single-Use?

A Dental Anaesthesia Syringe, Single-Use is a sterile, hand-held, manual dental instrument designed for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle.

This device is commonly used in dental procedures to numb a specific target area in the mouth, making it possible to carry out dental surgeries and procedures without causing discomfort to the patient.

The Role of CDSCO in Medical Device Regulation

CDSCO holds a key role in ensuring public health safety by overseeing the standardization and regulation of medical devices in India. This role covers a broad range of responsibilities, from policy-making to granting licenses, inspecting manufacturing sites, and ensuring post-marketing surveillance of medical devices.

Its medical device regulatory framework is designed to maintain a balance between the need to protect public health and the need to foster innovation in the medical device industry.

How to manufacture a Dental Anaesthesia Syringe, Single-Use

As a Class B medical device, manufacturing a Dental Anaesthesia Syringe, Single-Use, requires adherence to the regulatory framework set by the CDSCO, including obtaining a manufacturing license.

Fees for manufacturing license for Dental Anaesthesia Syringe, Single-Use

The fees applicable for the manufacturing license of a Class B device, such as the Dental Anaesthesia Syringe, Single-Use, falls under the MD5 license category. Thus, the costs are Rs. 5,000 for the license and Rs. 500 per product. For more information, visit here.

Why is a Manufacturing License Necessary for a Dental Anaesthesia Syringe, Single-Use?

Obtaining a manufacturing license is not merely a regulatory obligation, but a mark of commitment to the quality and safety of medical devices. This procedure ensures the production of reliable and effective devices, which translates into optimal patient care. A manufacturing license also shields consumers and patients from substandard products, thereby promoting a safe and efficient healthcare sector.

Steps to Obtain a CDSCO Manufacturing License for a Dental Anaesthesia Syringe, Single-Use

1. Compile pre-requisites documents, including Device Master File, Quality Management Certificate, Device Details, and Site details.
2. Submit the application through CDSCO's portal.
3. Await for the review process.
4. Upon approval, receive the manufacturing license.

While the process might present challenges, a clear comprehension of requirements and steadfast pursuit of compliance can streamline the procedure.

Frequently Asked Questions (FAQs)

Q. What is the risk class of a Dental Anaesthesia Syringe, Single-Use as per Medical Device Rules, 2017? A. The Dental Anaesthesia Syringe, Single-Use is classified as a Class B risk medical device.

Q. What license in needed to manufacture a Dental Anaesthesia Syringe, Single-Use? A. To manufacture a Dental Anaesthesia Syringe, Single-Use, an MD5 license is required.

Q. What is the fee for an MD5 license for a Dental Anaesthesia Syringe, Single-Use? A. The fees for an MD5 license for a Dental Anaesthesia Syringe, Single-Use are Rs. 5,000 for the license and Rs. 500 per product.

Q. Who will issue the manufacturing license for a Dental Anaesthesia Syringe, Single-Use? A. For a Class B medical device like the Dental Anaesthesia Syringe, Single-Use, the state FDA will issue the manufacturing license.

Q. Is repackaging of a Dental Anaesthesia Syringe, Single-Use considered manufacturing? A. Yes, as per the Drugs and Cosmetics Act's definition, repackaging of drugs is considered manufacturing. As medical devices are also classified as drugs under the Drug Act, repackaging of a Dental Anaesthesia Syringe, Single-Use requires an MD5 license.

Conclusion

Embarking on a journey to manufacture medical devices such as the Dental Anaesthesia Syringe, Single-Use might appear daunting. However, this journey can create efficient, safe, and cost-effective solutions for healthcare providers, ultimately benefiting patients.

If you are seeking consultation or assistance regarding the licensing process, reach out to the experts at Pharmadocx Consultants, call "+91-7404557227" or email at [email protected].