CDSCO Manufacturing License for Intraluminal oesophageal retractor

Introduction

The Central Drugs Standard Control Organization (CDSCO), the apex regulatory organization for pharmaceuticals and medical devices in India, plays a substantial role in ensuring the safety, efficacy, and quality of medicinal products. One of the critical aspects regulated by CDSCO is the manufacturing licenses for the medical device industry, which pegs high importance considering the role of these devices in patient care.

One such indomitable device is the Intraluminal oesophageal retractor, a medical device of immense relevance in the field of Gastroenterology. This blog post intends to shed comprehensive light on this device and the various licensing regulations associated with it guided by CDSCO.

You can find more information about CDSCO and its regulatory services related to medical devices here.

• What is Intraluminal Oesophageal Retractor?
• The Role of CDSCO in Medical Device Regulation
• How to manufacture Intraluminal Oesophageal Retractor
• Fees for manufacturing license for Intraluminal Oesophageal Retractor
• Why is a Manufacturing License Necessary for Intraluminal Oesophageal Retractor?
• Steps to Obtain a CDSCO Manufacturing License for Intraluminal Oesophageal Retractor
• Frequently Asked Questions (FAQs)
• Conclusion

What is Intraluminal Oesophageal Retractor?

The Intraluminal Oesophageal Retractor is a sterile, handheld manual surgical device deployed to divert the oesophagus away from the area of surgical treatment during cardiac electrical procedures such as cardiac ablation. The intraluminal oesophageal retractor functions to facilitate surgical site access and prevent potential injury to the oesophagus.

The device's function is instrumental in gastroenterology, primarily involving surgical procedures on the digestive system organs such as the stomach and intestines.

The Role of CDSCO in Medical Device Regulation

CDSCO's inception traces back to the 1940s, with its pivotal role in safeguarding public health through stringent regulations across healthcare industries. One key focus of CDSCO lies in framing and enforcing regulatory standards for medical devices to ensure their safety and efficacy.

CDSCO follows a risked-based approach for medical device regulation. This involves categorizing devices into classes A, B, C, and D, based on the risk associated with their use, with A being the lowest and D being the highest. The Intraluminal oesophageal retractor falls under Class B, thereby necessitating an MD5 license for manufacturing.

How to manufacture Intraluminal Oesophageal Retractor

Manufacturing the Intraluminal Oesophageal Retractor involves a series of processes that require adherence to quality standards and regulatory protocols.

Fees for manufacturing license for Intraluminal Oesophageal Retractor

The fee for an MD5 license, as required for manufacturing a Class B device like Intraluminal Oesophageal Retractor, is Rs. 5,000, with an additional fee of Rs. 500 per product.

Why is a Manufacturing License Necessary for Intraluminal Oesophageal Retractor?

Procuring a manufacturing license for medical devices, including the Intraluminal Oesophageal Retractor, is mandatory as per the Drugs and Cosmetics Act. This move aids in ensuring quality, safety, and efficiency in the production of medical devices. Furthermore, the license serves as testimony to regulatory compliance in the healthcare sector, safeguarding consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Intraluminal Oesophageal Retractor

1. Essential pre-requisites and documentation, including Device Master File, Quality Management Certificate, Device Details, Site details, etc.
2. The state FDA is responsible for submission and approval of the license for class B devices like Intraluminal Oesophageal Retractor.
3. Overcoming common challenges, including compliance with safety protocols, maintaining quality standards, etc.
4. Please note that the specifics of this process are extensive, and hence for detailed guidance, you can reach out to Pharmadocx Consultants.

Frequently Asked Questions (FAQs)

1. Q: What is the risk class of the Intraluminal Oesophageal Retractor as per Medical Device Rules, 2017?

   • The Intraluminal Oesophageal Retractor falls under Risk Class B as per Medical Device Rules, 2017.

2. Q: What license is needed to manufacture an Intraluminal Oesophageal Retractor?

   • An MD5 license is necessary for the manufacture of the Intraluminal Oesophageal Retractor.

3. Q: What is the fees for the MD5 license for Intraluminal Oesophageal Retractor?

   • The fees for the MD5 license are Rs. 5,000 for the license and Rs. 500 per product.

4. Q: Who will issue a manufacturing license for the Intraluminal Oesophageal Retractor?

   • The state FDA will issue the manufacturing license for class A sterile and measuring & class B devices such as Intraluminal Oesophageal Retractor.

5. Q: Is repackaging of the Intraluminal Oesophageal Retractor considered manufacturing?

   • Yes, repackaging of medical devices also falls under manufacturing, requiring an appropriate license. Consequently, repackaging of a Intraluminal Oesophageal Retractor would necessitate an MD5 license.

Conclusion

Navigating through the labyrinth of manufacturing licenses can be a daunting task. We at Pharmadocx Consultants can guide you through the process and cater to your bespoke needs. Feel free to reach out to us by placing a direct call at +91-7404557227 or drop us an email at [email protected] for any queries or assistance. To know more about the MD5 license, follow this article.