CDSCO Manufacturing License for Gastro-urological director

Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's premier national regulatory body under the Ministry of Health and Family Welfare, responsible for the regulation of drugs, cosmetics, and medical devices. One significant area of their duty involves issuing manufacturing licenses for different classes of medical devices.

In the healthcare industry, manufacturing licenses are of paramount importance. They not only ensure the production of standard and quality medical devices but also protects the consumers and patients from substandard products. This way, the validation a license brings establishes the credibility of a medical device manufacturer.

One such device that needs a manufacturing license under CDSCO is the Gastro-urological director, a beneficial tool in the world of gastroenterology. Detailed information about it and the necessary requirements for manufacturing can be found on CDSCO's portal here.

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

What is Gastro-urological director?

A Gastro-urological director is a slender, rod-like surgical instrument made of metal, typically with groove running along the centre of its distal shaft extending through an elongated malleable wire loop. Its primary purpose is to guide other devices or instruments within various gastroenterological/urological (GU) procedures.

Common uses of Gastro-urological director include directing catheters and other devices in the desired intracorporeal location during a GU procedure. They assist in accurate placement, ensuring minimal discomfort and harm to the patient.

The Role of CDSCO in Medical Device Regulation

Since its establishment, CDSCO has dedicated itself towards ensuring the quality of drugs, cosmetics, medical devices and diagnostics available to citizens. Their purpose aligns with their mission to safeguard and enhance public health by stringent regulation.

CDSCO's regulatory framework for medical devices involves a categorization depending on the risk associated. Each medical device, depending upon its risk class, requires a specific manufacturing license.

How to manufacture Gastro-urological director

The process of manufacturing a Gastro-urological director is strictly regulated by CDSCO under the class B category of medical devices, as per the Medical Device Rules, 2017.

Fees for manufacturing license for Gastro-urological director

The correct license for the manufacturing of Gastro-urological director, as it falls under class B, is MD5. The cost of the MD5 license is Rs. 5,000, along with an additional fee of Rs. 500 per product. Additional details about the MD5 license can be accessed here.

Why is a Manufacturing License Necessary for Gastro-urological director?

Obtaining a manufacturing license is obligatory as per the government regulations. It ensures the quality and safety of the Gastro-urological director produced. Regulatory compliance in medical device production is essential, ensuring the trust of healthcare providers and patients. In addition, it protects consumers and patients from using substandard and potentially harmful products.

Steps to Obtain a CDSCO Manufacturing License for Gastro-urological director

1. Prepare all necessary documentation, including the Device Master File, Quality Management Certificate, Device Details, and Site details.
2. Submit your application through the CDSCO's online portal.
3. Await approval, which can be expedited by making sure all documentation and prerequisites are properly satisfied.
4. Address any challenges that may arise, such as discrepancies in documents, by seeking professional advice or consulting with regulatory experts.

Frequently Asked Questions (FAQs)

Q1. What is risk class of Gastro-urological director as per Medical Device Rules, 2017?
The Gastro-urological director falls under class B.

Q2. What license is needed to manufacture Gastro-urological director?
The needed license for manufacturing Gastro-urological director is MD5.

Q3. What is fees for MD5 license for Gastro-urological director?
The fees for an MD5 license are Rs. 5,000 for the license and Rs. 500 per product.

Q4. Who will issue the manufacturing license for Gastro-urological director?
For class B devices like the Gastro-urological director, the state FDA will issue the license.

Q5. Is repackaging of Gastro-urological director considered manufacturing?
Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs, and hence medical devices, is considered manufacturing. Therefore, repackaging of Gastro-urological director also demands an MD5 license.

Conclusion

Navigating through the regulatory framework can be a challenging process. It is advisable to seek professional guidance ensuring a smooth application process and successfully obtaining a CDSCO Manufacturing License. For assistance regarding the CDSCO licensing process, reach out to Pharmadocx Consultants at "+91-7404557227" or via email at "[email protected]". Offering professional expertise, their consultation ensures a hassle-free licensing journey leading to success.