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CDSCO Manufacturing License for Laryngotracheal anaesthesia applicator

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Title: CDSCO Manufacturing License for Laryngotracheal Anaesthesia Applicator

Introduction

The Central Drugs Standard Control Organization (CDSCO) is a crucial governing body in India's medical industry. Upholding standards, regulations, and safety in the sphere of drugs and medical devices, CDSCO plays a significant role in the healthcare sector. A key facet of their responsibilities involves providing manufacturing licenses for medical devices, an essential credential which ascertains the safety and quality of medical devices in India.

One such crucial medical device in the healthcare industry is the Laryngotracheal Anaesthesia Applicator. Being used in various medical procedures, it holds immense importance. At this point, let me direct you towards CDSCO's portal for more information on the relevant regulatory practices - CDSCO Online

What is Laryngotracheal Anaesthesia Applicator?

The Laryngotracheal Anaesthesia Applicator is a necessary component in the medical industry, especially in the domain of surgery and anesthesia. It is a non-sterile container, prefilled with an anaesthetic agent, designed specifically for use in medical processes involving the oropharynx and upper airway. Through this applicator, the anaesthetic agent facilitates the relaxation of laryngotracheal reflexes prior to the insertion of an endotracheal tube or other kinds of tracheal tubes.

The Role of CDSCO in Medical Device Regulation

Since its inception, the CDSCO has been diligently working towards ensuring safety and standards in the domain of drugs and medical devices. A key part of its mission is to enact and enforce norms related to the manufacture of medical devices. Overseeing the regulatory framework for medical devices, CDSCO plays a significant role in elevating the quality standards and safety measures in the medical industry.

How to manufacture Laryngotracheal Anaesthesia Applicator

Fees for manufacturing license for Laryngotracheal Anaesthesia Applicator

The fee for acquiring an MD5 manufacturing license, required for the production of a Class B device like the Laryngotracheal Anaesthesia Applicator, is Rs. 5,000. Furthermore, a sum of Rs. 500 per product is also levied.

Why is a Manufacturing License Necessary for Laryngotracheal Anaesthesia Applicator?

Being a medical device, the making of a Laryngotracheal Anaesthesia Applicator necessitates a manufacturing license. This is mandatory, aiming to ensure quality and safety in medical device production. Furthermore, it underlines the importance of regulatory compliance in the healthcare sector, safeguarding consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Laryngotracheal Anaesthesia Applicator

In order to procure the manufacturing license, documentation such as the Device Master File, Quality Management Certificate along with Device Details, Site details etc. are essential. The application process begins with the submission of required documents and ends with the approval of the license. Despite inherent challenges in this process, being informed and proactive can help in effectively overcoming them.

Frequently Asked Questions (FAQs)

Q1. What is risk class of Laryngotracheal Anaesthesia Applicator as per Medical Device Rules, 2017?

The Laryngotracheal Anaesthesia Applicator is classified as a Class B device as per the Medical Device Rules, 2017.

Q2. What license in needed to manufacture Laryngotracheal Anaesthesia Applicator?

An MD5 license is required for the manufacture of the Laryngotracheal Anaesthesia Applicator.

Q3. What is fees for MD5 license for Laryngotracheal Anaesthesia Applicator?

The fee structure for an MD5 manufacturing license involves a sum of Rs. 5,000 and an additional Rs. 500 per product.

Q4. Who will issue manufacturing license for Laryngotracheal Anaesthesia Applicator?

For a Class B device like the Laryngotracheal Anaesthesia Applicator, the license will be issued by the state FDA.

Q5. Is repackaging of Laryngotracheal Anaesthesia Applicator considered manufacturing?

Yes. As per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Since medical devices are also classified as drugs, the repackaging of the Laryngotracheal Anaesthesia Applicator also necessitates a license, in this case, the MD5.

Conclusion

Understanding and walking through the licensing process can be thrilling, but at the same time, it can be arduous and, on times, confusing. Thus, we advise taking consultation or assistance for understanding or applying to the licensing process. Feel free to reach out to us at Pharmadocx Consultants, call +91-7404557227, or send an email to [email protected]. For more information about MD5 manufacturing license, please visit this link.

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