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CDSCO Manufacturing License for Gastrointestinal endoscopic clip, short-term

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Introduction

CDSCO (Central Drugs Standard Control Organization) plays a crucial role in ensuring the safety, efficacy, and quality of drugs, medical devices, and cosmetics in India. Its rigorous medical device licensing process ensures the quality and safety of medical devices produced in the country. It is essential for manufacturers to obtain the proper license if their product falls under the purview of the CDSCO.

This post discusses the Gastrointestinal endoscopic clip, a significant medical device with innumerable medical applications. Visit CDSCO's portal here for more in-depth information about CDSCO.

What is a Gastrointestinal Endoscopic Clip?

A Gastrointestinal Endoscopic Clip is a sterile clip that can be placed short-term (less than or equal to 30 days) within the gastrointestinal tract during an endoscopic procedure. It is used for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects. These clips perform a crucial role in gastrointestinal procedures, ensuring patient safety and efficient procedure execution.

The Role of CDSCO in Medical Device Regulation

The Central Drugs Standard Control Organization is responsible for approving and monitoring pharmaceuticals, medical devices, biologicals, and other categories products in India. The organization maintains a stringent regulatory framework for medical devices which ensures that only quality, safe products reach the patients.

How to manufacture Gastrointestinal Endoscopic Clips

Manufacturing Gastrointestinal Endoscopic Clips involves stringent quality control and a rigorous inspection process to ensure their safety and effectiveness. Having qualified personnel, sophisticated equipment, and adherence to global best practices forms the base for successful manufacturing.

Fees for a manufacturing license for Gastrointestinal Endoscopic Clips

Given that Gastrointestinal Endoscopic Clips fall under Risk Class B, the applicable license is MD5. The fees for an MD5 license include Rs.5,000 for the license and Rs.500 per product. More details about MD5 license can be found here.

Why is a Manufacturing License Necessary for Gastrointestinal Endoscopic Clips?

A manufacturing license is a must for the production of medical devices. Ensuring quality and safety in medical device production is pivotal in the healthcare sector. Regulatory compliance is essential to protect patients and end-users from substandard medical devices.

Steps to Obtain a CDSCO Manufacturing License for Gastrointestinal Endoscopic Clips

  1. Collection of documents required including Device Master File, Quality Management Certificate, Device Details, Site details, etc.,
  2. Submission of the application on CDSCO's portal.
  3. Await the review and approval of the application.
  4. Upon approval, payment of the license fee.

Challenges may occur during this process. That's why many organizations seek assistance from consultants with expertise in the CDSCO licensing process.

Frequently Asked Questions (FAQs)

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

A1. The Gastrointestinal Endoscopic Clip falls under Risk Class B.

Q2. What license is needed to manufacture Gastrointestinal Endoscopic Clip?

A2. To manufacture Gastrointestinal Endoscopic Clips, an MD5 license is required.

Q3. What is fees for MD5 license for Gastrointestinal Endoscopic Clip?

A3. The fee for an MD5 license is Rs. 5,000 for the license and Rs. 500 per product.

Q4. Who will issue manufacturing license for Gastrointestinal Endoscopic Clip?

A4. For Class B devices like Gastrointestinal Endoscopic Clip, the license is issued by the state FDA.

Q5. Is repackaging of Gastrointestinal Endoscopic Clip considered manufacturing?

A5. 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. Hence repackaging of Gastrointestinal Endoscopic Clip is also considered manufacturing requiring a license on MD5.

Conclusion

The process of obtaining a CDSCO manufacturing license can be complex and requires a deep understanding of the regulations and steps involved. It's advisable to seek professional assistance to ease the process. For any consultation or assistance related to the licensing process, feel free to reach out to Pharmadocx Consultants, call "+91-7404557227" or you can even drop a mail to "[email protected]".

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