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CDSCO Manufacturing License for Endoscopic biopsy valve, sterile

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is the central regulatory body for pharmaceuticals and medical devices in India, operating under the Ministry of Health and Family Welfare, Government of India. It plays a vital role in safeguarding and enhancing public health by ensuring the quality, safety, and efficacy of the products.

Manufacturing licenses are crucial to the medical industry as they regulate the production process to ensure that every medical product that reaches the market meets the necessary standards and is safe for consumers. One such essential medical product used frequently in the healthcare space is the endoscopic biopsy valve. This medical device is sterile and plays a multi-faceted role in gastroenterological procedures. To know more about CDSCO and its services, you can visit their portal here.

What is Endoscopic Biopsy Valve?

Endoscopic biopsy valve is a sterile medical device, predominantly used during an endoscopic procedure. This device is attached to the endoscope's biopsy port, which enables exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during the procedure. It's intently used to safeguard the quality and precision of the surgical technique.

The device is used extensively in procedures related to gastroenterology, aiding healthcare professionals in screening, diagnoses, and treatments related to gastrointestinal ailments.

The Role of CDSCO in Medical Device Regulation

The Central Drugs Standard Control Organization (CDSCO) has been serving as the principal drug regulatory body in India since its inception, with its primary function being to ensure the safety, effectiveness, and quality of all healthcare products circulating in the market. The organization has a well-established regulatory framework specifically curated to monitor operations concerning medical devices, including the manufacturing, sale, and distribution.

How to manufacture Endoscopic Biopsy Valve

Manufacturing of Endoscopic Biopsy Valve, a Class B device, demands rigorous quality control measures and compliance with the regulatory standards established by the CDSCO. It requires highly controlled environments and standardized techniques to maintain product sterility.

Fees for manufacturing license for Endoscopic Biopsy Valve

The fees for acquiring the manufacturing license for the Endoscopic Biopsy valve, which falls under the class B, is MD5. The license fee is Rs. 5,000, and the per product fee is Rs. 500 under MD5. Additionally, consulting charges may apply, and the cost may be dependent on the complexity of the application process and the product itself. Refer to this article to know more about MD5 license process.

Why is a Manufacturing License Necessary for Endoscopic Biopsy Valve?

Acquiring a manufacturing license is mandatory for all medical devices. It ensures the quality and safety of the product in terms of its performance and endurance. Proper regulation and compliance is crucial in the healthcare industry where the stakes for errors are always high. This regulation protects the consumers and patients from substandard products that could potentially harm or inaccurately diagnose and treat medical conditions.

Steps to Obtain a CDSCO Manufacturing License for Endoscopic Biopsy Valve

  1. Complete and compile all necessary documentation, including the Device Master File, Quality Management Certificate, Device Details, and Site details.
  2. Submit the application along with the required documents to the respective regulatory body.
  3. Await the evaluation and verification process by the authorities to ensure compliance with the standards.
  4. The license is granted upon successful approval by the authority.

There are common challenges one might face during the application and approval process, but with proper guidance and assistance, they can be easily overcome.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Endoscopic Biopsy Valve as per Medical Device Rules, 2017?
Endoscopic Biopsy Valve is classified as a Class B device under the Medical Device Rules, 2017.

Q2. What license in needed to manufacture Endoscopic Biopsy Valve?
To manufacture Endoscopic Biopsy Valve, a Class B device, you need an MD5 license.

Q3. What is the fees for MD5 license for Endoscopic Biopsy Valve?
The fees for MD5 license is Rs. 5,000 for the license and Rs. 500 per product.

Q4. Who will issue manufacturing license for Endoscopic Biopsy Valve?
For Class B devices like Endoscopic Biopsy Valve, the state FDA will issue the license.

Q5. Is repackaging of Endoscopic Biopsy Valve 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. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of Endoscopic Biopsy Valve is also considered manufacturing requiring a license on MD5.

Conclusion

Navigating the process of acquiring a manufacturing license for medical devices can be challenging and daunting. Seeking consultation or assistance to go through the process smoothens and clarifies the procedure, thereby reducing the burden on the manufacturers. For any queries or assistance, feel free to reach out to the Pharmadocx Consultants. You can call us at +91-7404557227, or send an email to [email protected], or visit our website. We are here to guide you every step of the way.

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