CDSCO Manufacturing License for Manual enema device

Introduction

CDSCO, short for Central Drugs Standard Control Organization, plays a vital role in monitoring and supervising all drug manufacturing processes in the country, including medical devices. Medical manufacturing licenses are a key branch in this procedure, ensuring quality and safety assurance in the production of medical devices. Let me introduce you to the Manual Enema Device, an extremely significant medical device in the field of gastroenterology. Read on to learn more about the device or you may visit CDSCO's portal here for further information.

• What is Manual Enema Device?
• The Role of CDSCO in Medical Device Regulation
• How to Manufacture Manual Enema Device
• Fees for Manufacturing License for Manual Enema Device
• Why is a Manufacturing License Necessary for Manual Enema Device?
• Steps to Obtain a CDSCO Manufacturing License for Manual Enema Device
• Frequently Asked Questions (FAQs)
• Conclusion

What is Manual Enema Device?

The Manual Enema Device, commonly used in the field of gastroenterology, is a non-sterile equipment used to manually inject fluid into the rectum, such as a saline solution. The purpose of this device is to aid in the evacuation of the lower intestinal tract by stimulating peristalsis and expanding the lower intestinal tract. Such procedure is often performed when there's a medical need to stimulate bowel movements.

The Role of CDSCO in Medical Device Regulation

CDSCO, with its rich history and mission to protect and improve public health, has established a robust regulatory framework for monitoring and controlling the manufacturing of medical devices. It plays a key role in ensuring medical devices including our Manual Enema Device, are developed and produced adhering to strict safety and quality standards.

How to Manufacture Manual Enema Device

The manufacturing of the Manual Enema Device involves complex processes and protocols which underlines the need for a manufacturing license. License not only ensures that these devices are manufactured maintaining the highest level of safety and quality, but also establishes that it complies with all the necessary regulations in place.

Fees for Manufacturing License for Manual Enema Device

As a Class B device, a Manual Enema Device requires a specific license, namely MD5 license, before its manufacturing. The fee for this license is Rs. 5,000, along with Rs. 500 added per product.

Why is a Manufacturing License Necessary for Manual Enema Device?

Ensuring a quality product is a prerequisite for every manufacturer, especially if it is a medical device. A manufacturing license is crucial for maintaining the high standard of production required for Manual Enema Devices. Regulatory compliance in the healthcare sector carries significance to protect consumers and patients from substandard or faulty products.

Steps to Obtain a CDSCO Manufacturing License for Manual Enema Device

1. Compilation and submission of necessary documents, such as Device Master File, Quality Management Certificate, particulars about the device and site, etc.
2. Observing the application process from submission to its approval.
3. Identifying the common challenges and finding solutions to overcome them.
4. Seeking aid from professional Consultant for smooth processing and approval of license.

Frequently Asked Questions (FAQs)

1. Q: What is the risk class of Manual Enema Device as per Medical Device Rules, 2017?

   A: The Manual Enema Device falls under Risk Class B.

2. Q: What license is needed to manufacture Manual Enema Device?

   A: MD5 license is needed to manufacture Manual Enema Device.

3. Q: What are the fees for MD5 license for Manual Enema Device?

   A: Fee for obtaining the MD5 license is Rs. 5,000 for license and Rs. 500 per product.

4. Q: Who will issue manufacturing license for Manual Enema Device?

   A: For Class A sterile and measuring & Class B devices - state FDA will issue license.

5. Q: Is repackaging of Manual Enema Device considered manufacturing?

   A: 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 Manual Enema Device is also considered manufacturing requiring a license on MD5.

Conclusion

The process of obtaining a manufacturing license for medical devices can be quite intricate, but don't worry, you do not have to do it alone. You can reach out to the experienced consultants at Pharmadocx for assistance. They can guide you through the process and help you fulfill the documentation requirements. You can find more details regarding MD5 license here. Feel free to reach out to Pharmadocx Consultants either through website or give them a call at "+91-7404557227" or send your queries at [email protected].