CDSCO Manufacturing License for Spring-loaded pneumoperitoneum needle, single-use

Introduction

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for pharmaceuticals and medical devices in India, and plays a vital role in safeguarding public health. It is tasked with the approval of new drugs, conduct of clinical trials, laying down standards for drugs, and regulating the quality of imported drugs.

Just as for pharmaceuticals, the manufacturing of medical devices also requires adherence to certain regulations and obtaining proper licenses. These regulations ensure the overall safety and effectiveness of the devices.

Today, we are focusing on a specific Class B medical device, the Spring-loaded pneumoperitoneum needle for single use. This device, as with all such medical devices, is of great importance due to its various applications in the field of gastroenterology.

For more details on the regulatory requirements for medical devices, one can refer to CDSCO's official portal here

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

What is Spring-loaded pneumoperitoneum needle?

The spring-loaded pneumoperitoneum needle is a slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is primarily used for the purpose of insufflation, for example, with carbon dioxide, to establish pneumoperitoneum prior to abdominal endoscopy.

The Role of CDSCO in Medical Device Regulation

With the objective of protecting and promoting public health, CDSCO was set up as the regulatory body for drugs and medical devices in India. It was established with the responsibility of maintaining a high standard of quality for these products, thereby ensuring their safety and effectiveness.

How to manufacture Spring-loaded pneumoperitoneum needle

Manufacture of medical devices in India, like the Spring-loaded pneumoperitoneum needle, must comply with CDSCO guidelines. Specific licenses are required to create different medical devices according to their risk class, and this particular Class B device requires an MD5 license.

Fees for manufacturing license for Spring-loaded pneumoperitoneum needle

According to CDSCO guidelines, the license fees for manufacturing a Class B device like the Spring-loaded pneumoperitoneum needle, are Rs 5,000 for license and Rs 500 per product.

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

A manufacturing license for medical devices like the Spring-loaded pneumoperitoneum needle is essential to ensure their quality and safety. Regulatory compliance is also vital in the healthcare sector in order to protect consumers and patients from substandard products, securing their wellbeing and health.

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

Acquiring a CDSCO manufacturing license involves meeting some pre-requisites, submitting the necessary documentation, going through the application process from submission to approval, and overcoming potential challenges.

Requisite documentation includes the Device Master File, Quality Management Certificate, and full Device Details and Site details.

Frequently Asked Questions (FAQs)

Q: What is the risk class of Spring-loaded pneumoperitoneum needle as per Medical Device Rules, 2017?
- As per the Medical Device Rules, 2017, the Spring-loaded pneumoperitoneum needle is categorized under Risk Class B.
Q: What license in needed to manufacture Spring-loaded pneumoperitoneum needle?
- The Spring-loaded pneumoperitoneum needle needs an MD5 license to be manufactured.
Q: What is the fee for MD5 license for Spring-loaded pneumoperitoneum needle?
- The fee for acquiring an MD5 license for a Spring-loaded pneumoperitoneum needle is Rs. 5,000 for license and Rs.500 per product.
Q: Who will issue the manufacturing license for Spring-loaded pneumoperitoneum needle?
- For Class B devices like the Spring-loaded pneumoperitoneum needle, the state FDA will issue the license.
Q:Is repackaging of Spring-loaded pneumoperitoneum needle considered manufacturing?
- Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs, and by extension, medical devices, is considered manufacturing. Hence, repackaging of Spring-loaded pneumoperitoneum needle constitutes manufacturing and requires an MD5 license.

Conclusion

Navigating the complexities of obtaining a CDSCO manufacturing license can be challenging without proper guidance and assistance. At Pharmadocx Consultants, we specialize in helping companies with this process.

For more information on this, you may refer to our detailed guide on acquiring an MD5 license.

For any consultations or assistance regarding the licensing process, feel free to reach out to us at Pharmadocx Consultants, or call us at +91-7404557227 or email to [email protected]. We are ready to assist you in your journey towards creating high-quality, compliant medical devices.