CDSCO Manufacturing License for Barium enema catheter

Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's primary regulatory body for pharmaceuticals and medical devices. The organization plays a pivotal role in maintaining and ensuring the safety and quality of the medical devices and drugs being manufactured and used in India. Medical device manufacturing licenses, issued by CDSCO, are an important aspect for manufacturers in this industry. They ensure these manufacturers maintain the highest standards and contribute towards improved public health.

One such device, often used in the medical field, that requires this licensing is a Barium Enema Catheter. A barium enema catheter is an indispensable medical device, used widely in the field of gastroenterology. To know more about the licensing process, you can visit the official CDSCO's portal here.

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

What is Barium Enema Catheter?

A Barium Enema Catheter is a flexible tube used to administer barium into the lower gastrointestinal tract for radiographic visualization of the area. The catheter specifically targets the rectum and colon, allowing healthcare professionals to capture clear images for diagnostic purposes.

These types of catheters are commonly used in procedures like a barium enema, a type of X-ray used to examine abnormalities in the large intestine.

The Role of CDSCO in Medical Device Regulation

The Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare is responsible for the quality control of drugs and medical devices in India. It plays an integral part in setting and regulating standards to ensure safety, efficacy, and quality in medical devices and drugs in India.

The organization has set forth a regulatory framework for medical devices, categorizing them into four classes- A, B, C, and D, each representing a different level of potential risk to the patient. A Barium Enema Catheter falls within Risk Class B.

How to manufacture Barium Enema Catheter

In line with CDSCO rules, manufacturing a Class B device like a Barium Enema Catheter requires adherence to several rigid protocols to ensure safety and quality. It is essential to secure the right manufacturing license and comply with the relevant regulations and guidelines.

Fees for manufacturing license for Barium Enema Catheter

For manufacturing a Class B medical device like a Barium Enema Catheter, an MD5 license is required. The license fee for an MD5 license is INR 5,000 and an additional INR 500 per product.

Why is a Manufacturing License Necessary for Barium Enema Catheter?

A manufacturing license is vital for any medical device. It not only legally allows the manufacture of the device, but also ensures that the product meets stringent quality and safety standards.

Regulatory compliance in the healthcare sector ensures the production of high-quality medical devices that meet the required safety standards. It also protects consumers and patients from substandard or unsafe products.

Steps to Obtain a CDSCO Manufacturing License for Barium Enema Catheter

Acquiring a manufacturing license involves several steps:

1. Gather the required documentation including Device Master File, Quality Management Certificate, Device Details, Site details etc.
2. Submit these details to the relevant authority.
3. Wait for the approval.
4. In case of challenges, seek expert guidance.

Frequently Asked Questions (FAQs)

1. Q. What is risk class of Barium Enema Catheter as per Medical Device Rules, 2017?

   A. Barium Enema Catheter falls under the Class B risk category as per the Medical Device Rules, 2017.

2. Q. What license is needed to manufacture Barium Enema Catheter?

   A. An MD5 license is required to manufacture Barium Enema Catheter.

3. Q. What is fees for MD5 license for Barium Enema Catheter?

   A. The fee for an MD5 license is INR 5,000, with additional costs of INR 500 per product.

4. Q. Who will issue manufacturing license for Barium Enema Catheter?

   A. For Class B devices like Barium Enema Catheter, the manufacturing license is issued by the state FDA.

5. Q. Is repackaging of Barium Enema Catheter considered manufacturing?

   A. Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. By further definitions, medical devices are also drugs, and thus, repackaging of Barium Enema Catheter also requires a manufacturing license, specifically an MD5.

Conclusion

Taking the correct steps and guidance while setting up a manufacturing unit for medical devices like the Barium Enema Catheter is essential. This helps ensure the process is carried out as per CDSCO regulations, while also maintaining the highest standards of safety and quality.

For assistance or consultation regarding the licensing process, you can reach out to Pharmadocx Consultants at "+91-7404557227". Alternatively, you can head over to our website, or email us directly at "[email protected]". Furthermore, you can read more about the process for obtaining an MD5 license here for greater understanding.