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CDSCO Manufacturing License for Gastro-oesophageal antireflux prosthesis

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Introduction

The importance of medical device manufacturing licenses in India is primarily regulated by the Central Drugs Standard Control Organization (CDSCO). As the national regulatory body for Indian pharmaceuticals and medical devices, CDSCO has a vital role in ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices in the country.

One of the essential medical devices that require strict regulation is the Gastro-oesophageal antireflux prosthesis. This device has significant importance in gastroenterology, specifically in treating gastro-oesophageal reflux disease (GERD) - a chronic, often progressive disease that affects millions worldwide. For more information and current updates, you can follow the CDSCO's portal.

What is Gastro-oesophageal antireflux prosthesis?

A gastro-oesophageal antireflux prosthesis is an implantable device introduced into the gastro- oesophageal sphincter. Its primary purpose is to reduce a sliding hiatal hernia, preventing the reflux of gastric contents into the oesophagus. This medical device offers a significant advantage in alleviating symptoms of GERD, such as heartburn, acid regurgitation, and difficulty swallowing. It prevents the stomach's corrosive contents from damaging the delicate lining of the oesophagus, reducing the risk of other health complications.

The Role of CDSCO in Medical Device Regulation

The mission of CDSCO remains to safeguard and enhance public health by assuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices. They have implemented a robust regulatory framework for medical device regulation, dividing medical devices into four risk categories: A being the lowest risk, D being the highest. For a Class C device like the Gastro-oesophageal antireflux prosthesis, a more stringent regulatory review is required given the device's more complex nature.

How to manufacture Gastro-oesophageal antireflux prosthesis

To manufacture a Gastro-oesophageal antireflux prosthesis, manufacturers must first obtain the necessary manufacturing licenses from the relevant medical device regulators like the CDSCO. The process includes stringent quality control measures, design and manufacturing standard adherence, and many other critical steps to ensure the safety and effectiveness of the device.

Fees for manufacturing license for Gastro-oesophageal antireflux prosthesis

The licensing fee for manufacturing a Class C device, such as a Gastro-oesophageal antireflux prosthesis, requires an MD9 license. The fee structure for MD9 is Rs. 50,000 for the license and Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Gastro-oesophageal antireflux prosthesis?

The production of a medical device like Gastro-oesophageal antireflux prosthesis involves complex design and manufacturing processes. A manufacturing license is thus necessary to ensure that such devices are produced under tightly controlled conditions and meet the necessary safety and performance requirements. The mandatory procurement of manufacturing licenses ensures compliance with essential health and safety regulations, protecting patients and consumers from substandard and potentially dangerous products.

Steps to Obtain a CDSCO Manufacturing License for Gastro-oesophageal antireflux prosthesis

Ensuring a smooth licensing journey requires comprehensive preparation. Documents like Device Master File, Quality Management Certificate, Device Details, and Site Details are among the prerequisites.

The process can be summarised as:

  1. Compile and submit the application and necessary documents.
  2. Await verification, inspection, and assessment.
  3. Address discrepancies and submit corrective actions, if necessary.
  4. Upon fulfillment of requirements, the license will be issued.

Frequently Asked Questions (FAQs)

Q. What is the risk class of Gastro-oesophageal antireflux prosthesis as per Medical Device Rules, 2017?

The Gastro-oesophageal antireflux prosthesis is categorized as a Class C medical device under the Medical Device Rules, 2017.

Q. What license is needed to manufacture Gastro-oesophageal antireflux prosthesis?

To manufacture Gastro-oesophageal antireflux prosthesis, an MD9 license is required.

Q. What is the fee for an MD9 license for Gastro-oesophageal antireflux prosthesis?

The fee for an MD9 license is Rs. 50,000 for the license and Rs. 1,000 per product.

Q. Who will issue the manufacturing license for Gastro-oesophageal antireflux prosthesis?

For class C devices like Gastro-oesophageal antireflux prosthesis, the CDSCO HQ in New Delhi will issue the manufacturing license.

Q. Is repackaging of Gastro-oesophageal antireflux prosthesis considered manufacturing?

Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Since medical devices are also drugs, repackaging of Gastro-oesophageal antireflux prosthesis would be considered a form of manufacturing that requires an MD9 license.

Conclusion

While the process of obtaining a CDSCO manufacturing license for medical devices might seem challenging, it is a crucial step ensuring the safety and effectiveness of the device. If you need detailed assistance, don't hesitate to reach out to the expert consultants at Pharmadocx Consultants. You can also call on +91-7404557227 or email your queries to [email protected]. For more information about the process and the required MD9 license, check out this detailed article.

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