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CDSCO Manufacturing License for Intestinal splint
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- CDSCO Licenses Blog
Introduction
The Central Drugs Standard Control Organization (CDSCO) is the main regulatory body in India, overseeing the safety, efficacy, and quality of drugs, cosmetics, and medical devices. Its role is crucial for the medical device industry as organizations such as the CDSCO are responsible for ensuring that the production and distribution of medical devices comply with the set standards and regulations.
The focus of today's post is the CDSCO manufacturing license for Intestinal Splints, a medical device widely recognized for its significance in the field of Gastroenterology. As an important regulatory body, CDSCO's licensing methodology ensures the safety and effectiveness of the products manufactured. For more details, refer to CDSCO's portal here.
- What is an Intestinal Splint?
- The Role of CDSCO in Medical Device Regulation
- How to manufacture an Intestinal Splint
- Fees for manufacturing license for Intestinal Splint
- Why is a Manufacturing License Necessary for Intestinal Splint?
- Steps to Obtain a CDSCO Manufacturing License for Intestinal Splint
- Frequently Asked Questions (FAQs)
- Conclusion
What is an Intestinal Splint?
An intestinal splint is a sterile, usually rigid device intended for implantation within the abdomen. Its main purpose is to stabilize a portion of the intestine or to protect an injured part of the intestine. These devices make a vast difference in improving patient health, especially those suffering from intestinal diseases.
The Role of CDSCO in Medical Device Regulation
The CDSCO has been dedicated to the safety and well-being of the public by regulating medical devices in India. Their regulatory framework for medical devices includes several regulations, guidelines, and procedures, taking into account the risk associated with the device.
How to manufacture an Intestinal Splint
To manufacture an intestinal splint in India, one needs to comply with the guidelines provided by CDSCO and obtain the necessary license.
Fees for manufacturing license for Intestinal Splint
Being a Class C device, the required license for manufacturing an intestinal splint is MD9. The fee for the MD9 license is Rs. 50,000 and an additional Rs. 1,000 per product.
Why is a Manufacturing License Necessary for Intestinal Splint?
Obtaining a manufacturing license is not just a formality but a necessary step to ensure quality and safety in the production of such vital medical devices. It indicates that the manufacturing process conforms to the regulatory compliance, helping to protect consumers and patients from substandard products.
Steps to Obtain a CDSCO Manufacturing License for Intestinal Splint
The licensing involves several prerequisites and documentation, including the Device Master File, Quality Management Certificate, Device Details, and Site details. The application process can be broken down into submission, review, and approval stages.
Frequently Asked Questions (FAQs)
Q: What is risk class of Intestinal Splint as per Medical Device Rules, 2017? A: Intestinal Splint is categorized as a Class C device under the Medical Device Rules.
Q: What license is needed to manufacture Intestinal Splints? A: An MD9 license is needed for manufacturing Intestinal Splints. To find more details about MD9, please refer to this link.
Q: What is the fees for MD9 license for Intestinal Splint? A: The fee for the MD9 license is Rs. 50,000 for the license and an additional Rs. 1,000 per product.
Q: Who will issue manufacturing license for Intestinal Splint? A: The CDSCO headquarters in New Delhi issues the manufacturing license for Class C devices, which includes an Intestinal Splint.
Q: Is repackaging of Intestinal Splint considered manufacturing? A: Yes, repackaging of medical devices is considered manufacturing. Hence, repackaging Intestinal Splint would require a license for MD9.
Conclusion
Obtaining a manufacturing license for medical devices is not as daunting as it sounds when you have the right guidance. At Pharmadocx Consultants, experts are available to assist with all your licensing needs. For professional consultation, please visit here, call on "+91-7404557227," or email us at "[email protected]".
The health sector is an ever-evolving industry that always welcomes advancements and improvements. Hence, ensuring your products are licensed and regulated should be a top priority to contribute to the progress of this vital field significantly.
