CDSCO Manufacturing License for Common bile duct dilator

Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a crucial role in the healthcare industry in India. This expert body under the Ministry of Health and Family Welfare governs the safety, quality, and performance of drugs, cosmetics and medical devices ensuring they meet requisite standards before they reach consumers. Specifically, with regards to medical devices, a key focus of the CDSCO lies in issuing manufacturing licenses. These licenses ensure that medical devices are manufactured under stringent regulations, to maintain their safety and efficacy. In this blog, I will be discussing the CDSCO manufacturing license for one such medical device, the Common bile duct dilator, a Class B medical device used primarily in gastroenterology.

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

What is Common bile duct dilator?

A Common bile duct dilator is a hand-held manual surgical instrument strategically designed to dilate the common bile duct. The common bile duct is the union of the cystic and hepatic ducts, which is a crucial part of our digestive system. Dilation of this duct can be necessary in various gastroenterological procedures, predominantly when treating diseases like gallstones and other hepatobiliary disorders.

The Role of CDSCO in Medical Device Regulation

CDSCO has since been a driving force in India's healthcare sector. Its primary mission has been to safeguard and enhance the public health by ensuring the safety, efficacy, and quality of medical devices and drugs. With regards to the medical devices specifically, CDSCO has outlined a comprehensive framework for regulation, which includes the classification of devices based on their risk factor, with Common bile duct dilator falling under Class B.

How to manufacture Common bile duct dilator

For successful manufacturing of any medical device, compliance with the regulations set by CDSCO is a must. For Common bile duct dilator (a Class B device), an MD5 license is required. As per the rules, strict adherence to the standardized manufacturing practices is expected to ensure that the final product is safe and effective.

Fees for manufacturing license for Common bile duct dilator

The manufacturing license for a Common bile duct dilator, which is a Class B medical device, comes under the realm of the MD5 license. The fees for the MD5 license amounts to Rs. 5,000 for the license and an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Common bile duct dilator?

A manufacturing license is mandatory for all medical devices, including the Common bile duct dilator. This license certifies that the manufacturer has adhered to the stringent quality and safety requirements set by the authorities. Moreover, having a manufacturing license reflects the manufacturer’s commitment to regulatory compliance, indicating that they value patient safety and quality above all else. Besides, it also protects consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Common bile duct dilator

Acquiring a manufacturing license involves following the due procedure laid out by the CDSCO,

1. Gathering the necessary documentation including a Device Master File, Quality Management Certificate, Device Details, Site details etc.,
2. Submitting the completed application along with all necessary attachments,
3. A through review of the application by the CDSCO,
4. Obtaining approval from the CDSCO.

The process might involve facing certain challenges, but knowing how to navigate them can make the process smoother.

Frequently Asked Questions (FAQs)

What is risk class of Common bile duct dilator as per Medical Device Rules, 2017?

Common bile duct dilator is classified under Class B as per Medical Device Rules, 2017.

What license in needed to manufacture Common bile duct dilator?

A MD5 license is required to manufacture Common bile duct dilator.

What is fees for MD5 license for Common bile duct dilator?

The fees for MD5 license for Common bile duct dilator is Rs. 5,000 for the license and an additional Rs. 500 per product.

Who will issue manufacturing license for Common bile duct dilator?

For Class B devices like Common bile duct dilator, state FDA will issue the license.

Is repackaging of Common bile duct dilator considered manufacturing?

Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by further definitions, medical devices are also drugs. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of Common bile duct dilator is also considered manufacturing requiring an MD5 license.

Conclusion

If you need any assistance or advice regarding the licensing process of Common bile duct dilator, feel free to reach out to the experts at Pharmadocx Consultants. You can reach us through a call at +91-7404557227, or shoot us an email at [email protected]. Our team is eager to assist you in understanding the MD5 manufacturing license procedure and requirements.