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CDSCO Manufacturing License for Implantable staple
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- CDSCO Licenses Blog
Introduction
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. The organization's primary function is to ensure the safety, efficacy, and quality of drugs, cosmetics, and medical devices in the country. Gaining a manufacturing license is a crucial step for medical device manufacturers, permitting them to produce medical devices that meet the stringent safety and quality standards set by CDSCO.
The focus of our discussion today is the Implantable Staple, a Class C medical device. This staple-like device performs a vital role in surgical procedures, particularly in dermatological and plastic surgery. For more details about CDSCO and its licensing process, please visit CDSCO's portal.
- What is an Implantable Staple?
- The Role of CDSCO in Medical Device Regulation
- How to manufacture Implantable Staples
- Fees for manufacturing license for Implantable Staples
- Why is a Manufacturing License Necessary for Implantable Staples?
- Steps to Obtain a CDSCO Manufacturing License for Implantable Staples
- Frequently Asked Questions (FAQs)
- Conclusion
What is an Implantable Staple?
An Implantable Staple, as the name suggests, is a staple-like device designed for internal use. Its primary purpose is to connect tissue internally, facilitating healing post-surgery. It is a staple device used in numerous medical and surgical procedures, especially those involving the treatment and reconstruction of the skin.
The Role of CDSCO in Medical Device Regulation
The CDSCO plays a pivotal role in ensuring the safety and efficacy of medical devices in India. Its mission is to safeguard and enhance public health by assuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices. The organization has a detailed regulatory framework for medical devices, classifying them into four categories (A, B, C, D) based on their potential risk, and stipulates specific manufacturing licenses for each.
How to manufacture Implantable Staples
To manufacture Implantable Staples, manufacturers must first obtain a Class C license (MD9), ensuring their facility and procedures meet the CDSCO's high safety and quality standards.
Fees for manufacturing license for Implantable Staples
The fee for an MD9 license for Implantable Staples is Rs. 50,000, with an additional Rs. 1,000 per product. Find more details on MD9 license procedure here.
Why is a Manufacturing License Necessary for Implantable Staples?
Acquiring a manufacturing license is mandatory. It ensures quality and safety in medical device production by requiring manufacturers to follow stringent norms. Regulatory compliance is crucial within the healthcare sector, protecting consumers and patients from subpar products.
Steps to Obtain a CDSCO Manufacturing License for Implantable Staples
Manufacturers must have certain prerequisite documents like the Device Master File, Quality Management Certificate, Device Details, Site details, etc., before applying. The application process involves submission, review, and approval stages. Challenges may arise, but credible and timely consultation can help overcome them.
Frequently Asked Questions (FAQs)
Q1. What is the risk class of Implantable Staple as per Medical Device Rules, 2017?
A1. Implantable Staple is a Class C medical device.
Q2. What license is needed to manufacture Implantable Staple?
A2. To manufacture Implantable Staple, an MD9 license is required.
Q3. What is the fee for an MD9 license for Implantable Staple?
A3. The fee for an MD9 license is Rs. 50,000 with an additional charge of Rs. 1,000 per product.
Q4. Who will issue manufacturing license for Implantable Staple?
A4. For Class C devices like Implantable Staple, CDSCO HQ in New Delhi will issue the license.
Q5. Is repackaging of Implantable Staple considered manufacturing?
A5. Yes, repackaging of Implantable Staple is considered manufacturing. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of Implantable Staple also requires an MD9 license.
Conclusion
Obtaining a CDSCO manufacturing license can sometimes be a complex process, but with the right assistance, it can become simple and straightforward. For personalized consultation or assistance regarding this licensing process, contact Pharmadocx Consultants. You could also directly call them at +91-7404557227 or drop an email at [email protected]. Pharmadocx provides expert guidance at every step, ensuring your manufacturing setup meets all the required regulations.
