CDSCO Manufacturing License for Endoscopic gastrointestinal stenosis dilator

Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's National Regulatory Authority, responsible for safeguarding and enhancing public health by ensuring quality, safety, and efficacy of drugs, cosmetics, and medical devices. Among these, manufacturing licenses for medical devices play a crucial role in maintaining high standards in the Medical Device industry. One such important device is the Endoscopic gastrointestinal stenosis dilator, an invaluable tool in Gastroenterology. Explore CDSCO's portal to know more.

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

What is Endoscopic Gastrointestinal Stenosis Dilator?

An Endoscopic Gastrointestinal Stenosis Dilator is a sterile invasive device, designed for expanding or dilating a narrowing lesion, primarily in the lumen of the gastrointestinal tract, under endoscopic visualization. This is predominantly used to treat conditions like oesophageal stricture or stenosis.

The Role of CDSCO in Medical Device Regulation

The CDSCO, founded over 75 years ago, has the primary aim of ensuring quality and safety of drugs and medical devices. It offers a comprehensive regulatory framework for medical devices, allowing patients and medical professionals to trust the standards of the devices they use.

How to manufacture Endoscopic Gastrointestinal Stenosis Dilator

Manufacturing of Endoscopic Gastrointestinal Stenosis Dilator involves several critical steps adhering to the guidelines and norms set by the CDSCO. It requires expert professionals and a licensed facility to ensure the quality and safety of the medical device.

Fees for manufacturing license for Endoscopic Gastrointestinal Stenosis Dilator

For the production of Endoscopic Gastrointestinal Stenosis Dilator, which falls under risk class B, a MD5 license is essential. The fee structure is Rs. 5,000 for the license and Rs. 500 per product.

Why is a Manufacturing License Necessary for Endoscopic Gastrointestinal Stenosis Dilator?

A manufacturing license is mandatory for the production of Endoscopic Gastrointestinal Stenosis Dilator. It ensures quality and safety in its production, enforces regulatory compliance in the healthcare sector, and protects patients and consumers from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Endoscopic Gastrointestinal Stenosis Dilator

Obtaining a manufacturing license requires specific pre-requisites like Device Master File, Quality Management Certificate, Device Details, Site details etc. The application process involves submission, scrutiny, inspection, and approval. The common challenges may include rigorous paperwork, strict compliances, and technical hurdles.

Frequently Asked Questions (FAQs)

1. What is the risk class of Endoscopic Gastrointestinal Stenosis Dilator as per Medical Device Rules, 2017?

   The Endoscopic Gastrointestinal Stenosis Dilator falls under Risk Class B.

2. What license is needed to manufacture Endoscopic Gastrointestinal Stenosis Dilator?

   The required license for manufacturing Endoscopic Gastrointestinal Stenosis Dilator is MD5.

3. What is the fee for MD5 license for Endoscopic Gastrointestinal Stenosis Dilator?

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

4. Who will issue the manufacturing license for Endoscopic Gastrointestinal Stenosis Dilator?

   For Class B devices like the Endoscopic Gastrointestinal Stenosis Dilator, the state FDA will issue the license.

5. Is repackaging of Endoscopic Gastrointestinal Stenosis Dilator considered manufacturing?

   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. So, repackaging of Endoscopic Gastrointestinal Stenosis Dilator is considered manufacturing and requires a MD5 license.

Conclusion

To navigate the complexity of obtaining a manufacturing license for an Endoscopic Gastrointestinal Stenosis Dilator, getting professional assistance is advised. You can reach out to Pharmadocx Consultants for consultation or assistance regarding the licensing process. Alternatively, call on +91-7404557227 or send an email to [email protected]. To know more about the process of getting MD5 license, you can read this article.