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CDSCO Manufacturing License for Dental anaesthesia syringe/needle

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Introduction

The Central Drugs Standard Control Organization (CDSCO) spearheads India's regulatory body landscape for the strict control and supervision of Pharmaceutical and Medical Device Industries. Ensuring safety, efficacy, and quality, it governs the manufacturing, importation, clinical trials, and marketing of drugs and medical devices.

The success in the medical device industry lies in the ethical and regulated production of devices that are vital in healthcare. A crucial cog in this well-oiled machine is the manufacturing licenses, which ascertain that only the best practices and utmost standards are maintained in producing these life-saving devices.

A perfect case study of this meticulous system in action is the manufacturing of a Dental Anaesthesia Syringe/Needle. This instrumental device plays a critical role in the field of dentistry, making dental procedures less painful and safer for patients. Take a walk with us through this blog as we unravel the world of CDSCO Manufacturing Licenses for Dental Anaesthesia Syringe/Needle. For more information, you can always refer to CDSCO's portal here.

What is Dental Anaesthesia Syringe/Needle?

In the realm of dentistry, the Dental Anaesthesia Syringe/Needle is a hand-held manual dental instrument that is intended for injecting an anaesthetic agent. This process can be done subcutaneously or intramuscularly using a prefilled, single-use cartridge. The device comes equipped with a sterile needle. Furtheremore, the needle may be attached or detached as per the requirement of the dental procedure.

Besides its practical application as an anaesthesia applicator, the Dental Anaesthesia Syringe/Needle is extensively used in dental surgeries, procedures, and treatments. The device's capability to numb a localised area in the oral cavity efficiently makes it an indispensable tool in every dentist's kit.

The Role of CDSCO in Medical Device Regulation

Established under the aegis of the Ministry of Health and Family Welfare, the CDSCO has a sole purpose. It ensures that all standards for safety, efficacy, and quality of medical devices are met adequately. The CDSCO oversees the regulatory framework for medical devices in India. Its vigilant regulatory purview extends from ensuring adherence to good manufacturing practices to the safe dispatch of these medical devices.

Let's shift the discussion towards our star, the Dental Anaesthesia Syringe/Needle. It falls under Risk Class B when it comes to the four-fold risk classification by CDSCO: A, B, C, and D, with A being the lowest and D being the highest. Accordingly, rules and regulations encompassing the manufacturing of a Class B device like the Dental Anaesthesia Syringe/Needle are in place to retain its efficacy and safety.

How to manufacture Dental Anaesthesia Syringe/Needle

Being a Class B device, The Dental Anaesthesia Syringe/Needle requires the MD5 license issued by the CDSCO for its manufacturing.

Fees for manufacturing license for Dental Anaesthesia Syringe/Needle

As per the guidelines, a fee of Rs. 5000 is required for the MD5 license, and an additional Rs. 500 is needed per product for the manufacturing of a Class B device like the Dental Anaesthesia Syringe/Needle.

Why is a Manufacturing License Necessary for Dental Anaesthesia Syringe/Needle?

It is not just legally mandatory to obtain a manufacturing license to manufacture Dental Anaesthesia Syringe/Needle, it essentially ensures quality and safety in production. Licensing is pivotal in maintaining regulatory compliance, protecting consumers and patients from consuming substandard products, and ultimately, upholding the credibility of healthcare.

Steps to Obtain a CDSCO Manufacturing License for Dental Anaesthesia Syringe/Needle

Multistep processes are involved in obtaining the license. These involve acquiring the prerequisites like the device master file, quality management certificate, device details, site details, among others, and going through the application process, from submission to approval. For a comprehensive guide on MD5 licenses, visit this Link.

Frequently Asked Questions (FAQs)

Q. What is the risk class of Dental Anesthesia Syringe/Needle as per Medical Device Rules, 2017?

A. The Dental Anesthesia Syringe/Needle falls under Risk Class B.

Q. What license is needed to manufacture Dental Anesthesia Syringe/Needle?

A. The required license to manufacture Dental Anesthesia Syringe/Needle is MD5.

Q. What are the fees for the MD5 license for Dental Anesthesia Syringe/Needle ?

A. The fee for the MD5 license is Rs. 5000 and Rs. 500 per device.

Q. Who will issue the manufacturing license for the Dental Anesthesia Syringe/Needle?

A. The manufacturing license for Class B devices like Dental Anesthesia Syringe/Needle is issued by the state FDA.

Q.What happens if the Dental Anesthesia Syringe/Needle is repackaged, will it be considered manufacturing?

A. Yes, as per the Drugs and Cosmetics Act's definition, the repackaging of drugs is considered manufacturing. As medical devices are also considered drugs, repackaging the Dental Anesthesia Syringe/Needle also requires an MD5 license.

Conclusion

We hope this informative blog post about the CDSCO Manufacturing License for Dental Anaesthesia Syringe/Needle has shed light on the significance of maintaining regulatory compliance in the healthcare sector. Be sure to reach out to Pharmadocx Consultants for further guidance or assistance. You can call them directly at +91-7404557227, or email them at this email. Their team is equipped to handle licensing processes and make your foray into manufacturing medical devices streamlined and hassle-free.

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