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CDSCO Manufacturing License for Manual rectal irrigation system
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- CDSCO Licenses Blog
Introduction
The Central Drugs Standard Control Organization (CDSCO) is responsible for regulating the quality of medical devices and ensuring their safety for human use. It sets standards and guidelines for the manufacturing, sale, and distribution of these devices in India. In the medical device industry, obtaining a manufacturing license is a crucial step in ensuring the quality of the device and its safety for the end-user.
One such system that requires a license from the CDSCO for its manufacture is the "Manual Rectal Irrigation System". This system plays a crucial role in gastroenterology by helping patients in the treatment of constipation or managing faecal incontinence.
The official portal for CDSCO can be found here.
- What is Manual Rectal Irrigation System?
- The Role of CDSCO in Medical Device Regulation
- How to manufacture Manual Rectal Irrigation System
- Fees for manufacturing license for Manual Rectal Irrigation System
- Why is a Manufacturing License Necessary for Manual Rectal Irrigation System?
- Steps to Obtain a CDSCO Manufacturing License for Manual Rectal Irrigation System
- Frequently Asked Questions (FAQs)
- Conclusion
What is Manual Rectal Irrigation System?
A Manual Rectal Irrigation System is a manually operated device used for the irrigation of the rectum with water, typically to provoke the defecation reflex for the evacuation of the bowels to treat or prevent constipation and reduce the risk of faecal incontinence. The device is portable and can be used by the patient himself or administered with assistance.
The Role of CDSCO in Medical Device Regulation
The CDSCO has been responsible for regulating the medical device industry in India. Its mission is to ensure the safety, efficacy, and quality of drugs, cosmetics, and medical devices. The CDSCO regulates the manufacturing of medical devices through different classification systems and the subsequent licensing process.
How to manufacture Manual Rectal Irrigation System
The manufacturing process of a Manual Rectal Irrigation System involves developing the device in accordance with the CDSCO guidelines and obtaining a CDSCO manufacturing license.
Fees for manufacturing license for Manual Rectal Irrigation System
The Manual Rectal Irrigation System falls under Class B of the CDSCO classification. Hence, a manufacturer requires an MD5 license. The fees for MD5 license is Rs. 5,000 and Rs. 500 per product.
Why is a Manufacturing License Necessary for Manual Rectal Irrigation System?
A manufacturing license is necessary for the production of Manual Rectal Irrigation Systems to ensure quality and safety. The regulatory compliance in the healthcare sector protects consumers and patients from substandard products and ensures a certain standard of quality in medical devices.
Steps to Obtain a CDSCO Manufacturing License for Manual Rectal Irrigation System
The process for obtaining a manufacturing license from the CDSCO involves submission of various documents such as Device Master File, Quality Management Certificate, Device Details, Site details etc. Despite its complexity, with proper guidance and consultation, obtaining the license can be achieved efficiently and swiftly.
Frequently Asked Questions (FAQs)
- What is the risk class of Manual Rectal Irrigation System as per Medical Device Rules, 2017?
Class B. - What license is needed to manufacture Manual Rectal Irrigation System?
An MD5 license is required. - What is the fee for the MD5 license for Manual Rectal Irrigation System?
The fee is Rs. 5,000 for license and Rs. 500 per product. - Who will issue the manufacturing license for Manual Rectal Irrigation System? The state FDA will issue the license.
- Is repackaging of Manual Rectal Irrigation System 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 the Drug Act and hence repackaging of Manual Rectal Irrigation System is also considered manufacturing requiring an MD5 license.
Conclusion
For any assistance in understanding and navigating the license process for the Manual Rectal Irrigation System, feel free to reach out to Pharmadocx Consultants. They can be contacted at +91-7404557227 or [email protected]. For more information about MD5 license, click here.
