CDSCO Manufacturing License for Gastrostomy button

Introduction

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices. Its main functions involve approving new licenses for drugs and medical devices, laying down the standards for drugs, control over the quality of imported drugs, coordination with state authorities, and providing expert advice to bring about uniformity in the enforcement of the Drugs and Cosmetics Act.

In the medical devices sector, obtaining manufacturing licenses is an essential part of ensuring adherence to safety guidelines, maintaining the quality of devices, and ultimately delivering optimal patient care. Among its various medical devices, in this blog post, we delve into the Gastrostomy Button - a medical device that plays a crucial role in healthcare by enabling long-term enteral feeding. More details about the Gastrostomy Button and its license-related requirements can be found on CDSCO's portal here.

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

What is a Gastrostomy Button?

A Gastrostomy button is a sterile, short tube inserted percutaneously into the stomach to allow for long-term enteral feeding. It is a critical device in gastroenterology used typically when oral intake is not adequate or possible. This relatively low-profile device allows patients to maintain an active lifestyle while still receiving the necessary nutrients.

The Role of CDSCO in Medical Device Regulation

CDSCO's role in medical devices regulation is to protect and preserve public health by ensuring safety, efficacy, and quality of the medical devices manufactured and distributed in India. It accomplishes this via a broad regulatory framework encompassing the entire lifecycle of a medical device, from concept and design through distribution and use.

How to manufacture a Gastrostomy Button

The manufacturing of a Gastrostomy Button is a detailed process that requires sterilization techniques and quality controls in accordance with guidelines set by the CDSCO and other relevant authorities.

Fees for manufacturing license for Gastrostomy Button

Gastrostomy Buttons fall under Risk Class C and therefore require an MD9 license for manufacturing. The fee for an MD9 license is Rs. 50,000, with an additional Rs. 1,000 per product.

Why is a Manufacturing License Necessary for a Gastrostomy Button?

Compliance with regulatory norms via acquiring a manufacturing license ensures quality and safety in medical device production. Consequently, this assures healthcare providers, patients, and consumers that the Gastrostomy Buttons manufactured under these guidelines would adhere to the required standards and deliver desired clinical outcomes. Regulatory compliance also protects consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for a Gastrostomy Button

1. Prepare the necessary documents: Device Master File, Quality Management Certificate, Device Details, Site Details.
2. Application submission with all required information.
3. Wait for CDSCO approval.
4. Overcome any challenges that may arise during this process.

Frequently Asked Questions (FAQs)

1. Q1: What is the risk class of a Gastrostomy Button as per Medical Device Rules, 2017?
   A1: As per Medical Device Rules, 2017, a Gastrostomy Button is categorized under Risk Class C.

2. Q2: What license is needed to manufacture a Gastrostomy Button?
   A2: An MD9 License is required to manufacture a Gastrostomy Button.

3. Q3: What is the fee for an MD9 license for a Gastrostomy Button?
   A3: The fee for an MD9 license is Rs. 50,000, with an additional Rs. 1,000 per product.

4. Q4: Who will issue the manufacturing license for a Gastrostomy Button?
   A4: For Class C devices like the Gastrostomy Button, the CDSCO HQ in New Delhi will issue the license.

5. Q5: Is repackaging of a Gastrostomy Button 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 a Gastrostomy Button is also considered manufacturing, requiring an MD9 license.

Conclusion

Remember, compliance isn't just about adhering to rules; it's about ensuring patient safety and delivering quality healthcare. If you need assistance regarding the licensing process for medical devices, reach out to the experts at Pharmadocx Consultants through their website here, call +91-7404557227 or email to [email protected]. For more information about the MD9 license, click here.