CDSCO Manufacturing License for Endoscopic overtube, reusable

Introduction

The Central Drugs Standard Control Organization (CDSCO) is a highly esteemed regulatory body in India that ensures the safety, quality, and efficacy of drugs and medical devices. It plays a crucial role in maintaining the standards of the health care sector. One of its principal functions is the issuance of licenses to manufacture these medical devices. These licenses are classified into different categories depending on the risk posed by the device.

Let's put the spotlight on one such device - the Endoscopic overtube, reusable. This highly significant tool is used in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures. This proves its significance in the medical field, especially in the realm of gastroenterology.

To get more insights about the CDSCO and the licensing process, you can visit their portal here.

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

What is Endoscopic Overtube, Reusable?

An Endoscopic Overtube is a long tubular device that is used in combination with a flexible endoscope. The main purpose of this device is to aid in endoscopic insertions during procedures like upper and lower gastrointestinal tract endoscopy. It also helps secure a pathway for multiple endoscopic intubations, thereby enhancing the efficiency and safety of such processes.

The Role of CDSCO in Medical Device Regulation

The mandate of CDSCO extends beyond just ensuring the quality of medical equipment. It is also responsible for approving new drugs, ensuring adherence to global standards, and improving the overall health infrastructure across the country. It also regulates the sale, distribution, and use of medical devices to ensure that they have been adequately tested for safety and efficacy.

How to manufacture Endoscopic Overtube, Reusable

The manufacturing process of the Endoscopic Overtube demands precision, an understanding of medical requirements, and a fine balance between efficiency and safety.

Fees for manufacturing license for Endoscopic Overtube, Reusable

The Endoscopic Overtube falls under Class B of risk category, and hence the license required for its manufacturing is MD5. The fees for the MD5 license is Rs. 5,000 with an additional charge of Rs. 500 per product.

Why is a Manufacturing License Necessary for Endoscopic Overtube, Reusable?

Getting a license to manufacture medical devices is not just a regulatory requirement, but a step towards safeguarding the interests of patients and the healthcare sector. A license ensures that the manufacturing processes adhere to stringent quality and safety rules and checks any malpractices. The need for regulatory compliance in the healthcare industry is to protect end-users from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Endoscopic Overtube, Reusable

1. Submission of essential documents like Device Master File, Quality Management Certificate, Device and Site details
2. Submitting the application for MD5 license
3. Verification and validation by the regulatory body
4. Approval or disapproval of the license

The application process can often be complex and riddled with challenges. But with the right guidance and assistance, one can smoothly navigate through it all.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of the Endoscopic Overtube as per Medical Device Rules, 2017?

• The Endoscopic Overtube falls under Class B risk category.

Q2. What license is needed to manufacture the Endoscopic Overtube, Reusable?

• The license required to manufacture this device is MD5.

Q3. What is the fee for the MD5 license for the Endoscopic Overtube, Reusable?

• The fee for the MD5 license is Rs. 5,000 with an additional charge of Rs. 500 per product.

Q4. Who will issue the manufacturing license for the Endoscopic Overtube, Reusable?

• For Class B devices, which includes the Endoscopic Overtube, the state FDA will issue the license.

Q5. Is repackaging of the Endoscopic Overtube considered manufacturing?

• Yes, repackaging falls under the definition of manufacturing as per the Drugs and Cosmetics Act's definition With respect to Medical Device Rules, repackaging of Endoscopic Overtube is also considered manufacturing requiring a license on MD5.

Conclusion

Obtaining a manufacturing license for medical devices might seem like a daunting task. But with the right guidance and expertise, this process can turn out to be smooth and hassle-free. At Pharmadocx Consultants, we are committed to guiding you through every step of this process. For any consultation or assistance regarding the licensing process, feel free to call us at +91-7404557227 or email us at [email protected].

For more detailed information about MD5 license, please check out this link. If you are dealing with a class C or D device that requires an MD9 license, please refer to this link.