CDSCO Manufacturing License for Irrigating wound retractor device.

Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in the Indian healthcare sector; it is responsible for the approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organizations, and providing expert advice on technical matters. One of their key roles includes the regulation of medical devices, where they classify, grant licenses, apply quality control measures, and ensure safe and effective devices reach patients.

One such critical medical device that requires strict regulation is the Irrigating Wound Retractor Device. This device plays an essential role in various surgical procedures, increasing the visibility of the surgical site and maintaining a clean and safe environment for the surgery. For accessing their online application portal, use this link.

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

What is an Irrigating Wound Retractor Device?

An Irrigating Wound Retractor Device is a medical tool used by surgeons to retract a surgical incision. It allows effective access to the surgical wound while providing constant irrigation to maintain a sterile field. It also acts as a conduit for the removal of fluid from the surgical site.

Common uses include surgeries that require open larger incisions and require constant irrigation. Procedures such as abdominal surgeries, orthopedic surgeries, and major reconstruction surgeries often use this device.

The Role of CDSCO in Medical Device Regulation

The CDSCO is entrusted with the mandate to regulate the import, manufacture, and distribution of drugs and medical devices to ensure high-quality standards. CDSCO also has the responsibility of approving new drugs and conducting clinical trials.

Regarding medical devices, CDSCO classifies them into four categories depending upon their risk level - A, B, C, and D. Class A represents the lowest risk while Class D represents the highest. Accordingly, the Irrigating Wound Retractor Device falls under Class B, requiring an MD5 license for manufacturing.

How to Manufacture an Irrigating Wound Retractor Device

For effectively manufacturing an Irrigating Wound Retractor Device, standardized procedures, compliance with regulatory guidelines, along with obtaining proper licensing and approvals are mandatory. Trained labor, use of high-quality materials, adoption of sterile manufacturing processes, and stringent quality controls also play a pivotal role.

Fees for Manufacturing License for an Irrigating Wound Retractor Device

For a Class B device like an Irrigating Wound Retractor, a license called MD5 is required, which costs Rs. 5,000, and an additional Rs. 500 is needed for each product. Detailed fee structure can be found on this link.

Why is a Manufacturing License Necessary for an Irrigating Wound Retractor Device?

It is mandatory to obtain a manufacturing license for medical devices like the Irrigating Wound Retractor to ensure safety standards and quality controls. Regulatory compliance safeguards the healthcare sector, protecting patients from substandard products. It establishes trust among consumers and maintains the reputation of manufacturers.

Steps to Obtain a CDSCO Manufacturing License for an Irrigating Wound Retractor Device

Obtaining a manufacturing license involves several steps:

1. Acquiring prerequisite documents like Device Master File, Quality Management Certificate, Device Details, and Site details.
2. Submission of the application to the relevant regulatory body.
3. Undergoing scrutinization and review of the application.
4. Approval of the license upon successful assessment.

Common challenges include delay due to incomplete application and lack of prerequisite documents. To overcome such obstacles, ensure completeness and accuracy of your application and documents.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Irrigating Wound Retractor Device as per Medical Device Rules, 2017? The Irrigating Wound Retractor Device falls under Class B.

Q2. What license is needed to manufacture the Irrigating Wound Retractor Device? The MD5 license is required to manufacture an Irrigating Wound Retractor Device.

Q3. What is the fee for an MD5 license for the Irrigating Wound Retractor Device? The fee for an MD5 license for the Irrigating Wound retractor Device is Rs. 5,000, plus an additional Rs. 500 per product.

Q4. Who will issue the manufacturing license for the Irrigating Wound Retractor Device? For Class B devices like the Irrigating Wound Retractor Device, the State FDA (Food and Drug Administration) will issue the license.

Q5. Is repackaging of the Irrigating Wound Retractor Device considered manufacturing? Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs and medical devices like the Irrigating Wound Retractor Device is also considered manufacturing and requires an MD5 license.

Conclusion

Do you need further assistance or consultation regarding the licensing process for an Irrigating Wound Retractor Device? Reach out to the experts at Pharmadocx Consultants or call at +91-7404557227. Feel free to send your queries to [email protected]. Let professionals guide you through the tedious procedure, improving your chances of success in obtaining a manufacturing license for the Irrigating Wound Retractor Device.