CDSCO Manufacturing License for Spring-loaded pneumoperitoneum needle, reusable

Introduction

The Central Drugs Standard Control Organization (CDSCO) is one of the chief regulatory authorities responsible for ensuring the quality, safety, and efficacy of medical devices in India. It is instrumental in the certification and licensing of these devices, which is of utmost importance in the health sector. Obtaining a manufacturing license is not just a matter of regulatory compliance; it is vital for maintaining the paramount standards of medical device production.

We bring to you deeper and valuable insights into acquiring a manufacturing license for a quintessential medical device - the Spring-loaded pneumoperitoneum needle, reusable. Being a reusable device designed to introduce or remove gases from the peritoneal cavity, it holds significant relevance in gastroenterology and is used primarily for abdominal endoscopic procedures. You can refer to the CDSCO's portal here for more information.

What is a Spring-loaded pneumoperitoneum needle, reusable?
The Role of CDSCO in Medical Device Regulation
How to manufacture Spring-loaded pneumoperitoneum needle, reusable
Fees for manufacturing license for Spring-loaded pneumoperitoneum needle, reusable
Why is a Manufacturing License Necessary for Spring-loaded pneumoperitoneum needle, reusable?
Steps to Obtain a CDSCO Manufacturing License for Spring-loaded pneumoperitoneum needle, reusable
Frequently Asked Questions (FAQs)
Conclusion

What is a Spring-loaded pneumoperitoneum needle, reusable?

A Spring-loaded pneumoperitoneum needle, reusable, is a narrow, sharply pointed metal tube specifically designed to instill or remove gas from the peritoneal cavity in various therapeutic or surgical/radiological procedures. It is frequently used for the purpose of inflating the peritoneal cavity with gasses like carbon dioxide (CO2), thereby creating a pneumoperitoneum for subsequent abdominal endoscopy.

The Role of CDSCO in Medical Device Regulation

Established as a premiere regulatory authority, CDSCO ensures high quality, safety, and efficacy standards for pharmaceuticals and medical devices in India. It formulates and implements comprehensive regulatory framework for medical devices, effectively controlling the manufacturing, sale, import, and distribution of these devices.

How to manufacture Spring-loaded pneumoperitoneum needle, reusable

Manufacturing of Spring-loaded pneumoperitoneum needle, reusable, involves several meticulous stages. These stages are stringently overseen to adhere to the quality norms set by CDSCO, and the final product is subjected to thorough quality control tests to maintain its precision and efficacy.

Fees for manufacturing license for Spring-loaded pneumoperitoneum needle, reusable

Given that the Spring-loaded pneumoperitoneum needle, reusable is classified under Risk Class B, the required license for its manufacturing is MD5. The fees associated with this license is Rs. 5,000 for the license itself and an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Spring-loaded pneumoperitoneum needle, reusable?

Obtaining a manufacturing license is mandatory for medical devices, including the Spring-loaded pneumoperitoneum needle, reusable. This license ensures that the device meets the requisite norms of quality and safety, becoming a mark of assurance for healthcare professionals and patients alike. It is indicative of compliance with the regulations, thereby safeguarding consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Spring-loaded pneumoperitoneum needle, reusable

Prepare the required documents, including the Device Master File, Quality Management Certificate, Device Details, Site Details, etc.
Submit your application on the CDSCO's portal.
The submitted application will undergo comprehensive scrutiny before approval.
Handle any challenges in the process by taking due help from consultants or referring to procedural forums like this.

Frequently Asked Questions (FAQs)

Q1: What is the risk class of Spring-loaded pneumoperitoneum needle, reusable, as per Medical Device Rules, 2017?

The Spring-loaded pneumoperitoneum needle, reusable, is classified under Risk Class B.

Q2: What license is needed to manufacture Spring-loaded pneumoperitoneum needle, reusable?

The manufacturing license required for this device is MD5.

Q3: What is the fee for the MD5 license for Spring-loaded pneumoperitoneum needle, reusable?

The fee for the MD5 license is Rs. 5,000 for the license and an additional Rs. 500 per product.

Q4: Who will issue the manufacturing license for Spring-loaded pneumoperitoneum needle, reusable?

For Class B devices such as this one, the state FDA issues the manufacturing license.

Q5: Is repackaging of Spring-loaded pneumoperitoneum needle, reusable, considered manufacturing?

Yes, repackaging of the Spring-loaded pneumoperitoneum needle, reusable, is considered manufacturing as per the Drugs and Cosmetics Act's definition of manufacturing. It requires an MD5 license.

Conclusion

Navigating through the intricate process of obtaining a manufacturing license can be quite demanding without professional help. At Pharmadocx Consultants, we provide expert consultation and assistance in this process. Feel free to reach out to us here, call us at +91-7404557227, or email us your queries at [email protected]. We are here to guide you through your journey, ensuring you meet all your regulatory considerations.