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CDSCO Manufacturing License for Periodontal tissue reconstructive material
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- CDSCO Licenses Blog
#Introduction
The Central Drugs Standard Control Organization (CDSCO) plays a significant role in assuring the safety, efficacy, and quality of drugs, cosmetics, diagnostics, and devices in India. Overseeing the regulatory framework for medical devices, it plays a crucial role in the medical industry. One of its primary responsibilities is issuing manufacturing licenses for these medical devices, thus ensuring quality and protecting the public from substandard products.
Specifically, this article will delve into the manufacturing license for Periodontal Tissue Reconstructive Material, a Class C medical device primarily used for dental purposes.
For more details about the CDSCO and its regulatory framework, please visit the CDSCO's official portal here.
##What is Periodontal Tissue Reconstructive Material?
Periodontal Tissue Reconstructive Material is a sterile viscous material. It is generally injected into the buccal mucosa to treat deficiencies of the gingiva, typically interdental papillae, during the treatment of intermediate-stage periodontal disease. Its primary aim is tissue reconstruction in periodontal disease.
##The Role of CDSCO in Medical Device Regulation
Establishing a balanced perspective on patient safety and medical innovation is a core principle underpinning the CDSCO's mission. It regulates the manufacture, import, distribution, and sale of medical devices. This process ensures the quality of devices and safeguards patients from inferior or harmful equipment.
##How to manufacture Periodontal Tissue Reconstructive Material
Dealing with Periodontal Tissue Reconstructive Material production involves several stringent requirements and practices to maintain sterility and efficacy. It would help if you had a facility that complies with the guidelines laid down by regulatory bodies like CDSCO and follows Good Manufacturing Practices (GMP).
##Fees for manufacturing license for Periodontal Tissue Reconstructive Material
Given that Periodontal Tissue Reconstructive Material falls under Class C category, it requires an MD9 license. The fees associated with this license are Rs. 50,000 for the license itself and an additional Rs. 1,000 per product. More information on MD9 licenses can be found here.
##Why is a Manufacturing License Necessary for Periodontal Tissue Reconstructive Material?
Obtaining a manufacturing license for making Periodontal Tissue Reconstructive Material from CDSCO is imperative. Not only is it a legal requirement, but this regulation ensures the quality and safety of the medical devices produced. Adhering to this rule means you're not just complying with the law but prioritising patient safety.
##Steps to Obtain a CDSCO Manufacturing License for Periodontal Tissue Reconstructive Material
Obtaining a CDSCO license involves furnishing several documents such as the Device Master File, Quality Management Certificate, complete details on the device, its application, site details, among other requirements. Once compiled, the application is processed through several stages from submission to approval. Your application's success can be hindered by many common challenges – dealing with them requires a working knowledge of the process.
##Frequently Asked Questions (FAQs)
Q1: What is the risk class of Periodontal Tissue Reconstructive Material as per Medical Device Rules, 2017?
A1: Periodontal Tissue Reconstructive Material falls under Class C as per Medical Device Rules, 2017.
Q2: What license is needed to manufacture Periodontal Tissue Reconstructive Material?
A2: An MD9 License is required to manufacture Periodontal Tissue Reconstructive Material.
Q3: What is the fees for MD9 license for Periodontal Tissue Reconstructive Material?
A3: The fees is Rs. 50,000 for the MD9 license and Rs. 1,000 per product.
Q4: Who will issue the manufacturing license for Periodontal Tissue Reconstructive Material?
A4: For Class C devices like Periodontal Tissue Reconstructive Material, CDSCO HQ in New Delhi will issue the manufacturing licenses.
Q5: Is repackaging of Periodontal Tissue Reconstructive Material considered manufacturing?
A5: Yes, as per the Drugs and Cosmetics Act, repackaging of drugs, including medical devices, is considered manufacturing. Thus, repackaging of Periodontal Tissue Reconstructive Material also requires an MD9 license.
##Conclusion
Securing manufacturing licenses may feel daunting, but don't worry. Assistance is readily available through consultants like Pharmadocx who can guide you through the process. For further queries or assistance, feel free to reach out to Pharmadocx Consultants on +91-7404557227 or email at [[email protected]]. Alternatively, you can visit their website here. Don't let regulatory hurdles slow down your medical innovation journey. The right help is a call away.
