CDSCO Manufacturing License for Sterile Hemostatic clip applier

Introduction

The Central Drugs Standard Control Organization (CDSCO) holds the unique responsibility of safeguarding and enhancing public health in India. Tasked with the approval and regulation of drugs, cosmetics, and medical devices, it plays a crucial role in the medical industry.

A pivotal aspect of CDSCO's role is the implementation and enforcement of manufacturing licenses. These licenses are a pillar of the medical device industry, ensuring a standard of safety and quality is maintained across all products.

The focus of our discourse today is the Sterile Hemostatic Clip Applier, a vital device in the realm of medical procedures. This blog will explore its functionalities, manufacturing licenses, and its underlying importance in healthcare.

Visit CDSCO's portal for deeper insights into the organization's endeavors.

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

What is Sterile Hemostatic Clip Applier?

An integral part of surgical procedures, the Sterile Hemostatic Clip Applier, simply defined, is a surgical device designed to apply a hemostatic clip for ligation of a blood vessel. Its primary purpose revolves around maintaining hemostasis (balance of blood flow) during surgical procedures. These devices are commonly used in surgeries involving the gastrointestinal tract where accurate and efficacious seaming of blood vessels is paramount.

The Role of CDSCO in Medical Device Regulation

History records CDSCO as an organization fashioned with the mission of advancing public health in India through the regulation and supervision of medical devices. Notably, CDSCO's comprehensive regulatory framework for medical devices is a testament to its commitment to healthcare.

How to manufacture Sterile Hemostatic Clip Applier

Producing a device such as the Sterile Hemostatic Clip Applier encompasses precision-driven manufacture, stringent checks, and regulatory compliance. Due to its risk class, the accomplishment of all these is underlined by acquiring an MD5 license, which is tailored for Class B devices according to the Medical Device Rules, 2017.

Fees for manufacturing license for Sterile Hemostatic Clip Applier

To acquire the MD5 license, a fee of Rs. 5,000 is required for the license, and an additional fee of Rs. 500 per product is applicable.

Why is a Manufacturing License Necessary for Sterile Hemostatic Clip Applier?

Without the organizational enforcement of manufacturing licenses, manufacturers have unchecked liberty leading to disharmonized product quality, safety, and efficacy. Ensuring the quality and safety of medical device production is integral, highlighting the need for an MD5 license to manufacture the Sterile Hemostatic Clip Applier. Furthermore, regulatory compliance underpins the healthcare sector while safeguarding consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Sterile Hemostatic Clip Applier

Documents required include the Device Master File, Quality Management Certificate, details related to the device, and site details. The application process involves submission, scrutiny, approval, and finally, the issuance of the license. More Information

Frequently Asked Questions (FAQs)

1. What is the risk class of Sterile Hemostatic Clip Applier as per Medical Device Rules, 2017?

   The Sterile Hemostatic Clip Applier falls under Risk Class B.

2. What license is needed to manufacture Sterile Hemostatic Clip Applier?

   To manufacture the Sterile Hemostatic Clip Applier, an MD5 license is required.

3. What is the fee for an MD5 license for Sterile Hemostatic Clip Applier?

   The fees for the MD5 license for a Sterile Hemostatic Clip Applier is Rs. 5,000 for the license and Rs. 500 per product.

4. Who will issue a manufacturing license for Sterile Hemostatic Clip Applier?

   The state FDA will issue the license for Sterile Hemostatic Clip Appliers.

5. Is repackaging of Sterile Hemostatic Clip Applier considered manufacturing?

   Yes, according to the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. As medical devices are also classified as drugs, repackaging of a Sterile Hemostatic Clip Applier also necessitates a manufacturing license, MD5.

Conclusion

The labyrinth of licensing for medical devices can be daunting for many. You do not have to navigate it alone. You can reach out for consultation or assistance regarding the licensing process to Pharmadocx Consultants. Always remember, we are just a call "+91-7404557227" or an email "[email protected]" away.