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CDSCO Manufacturing License for Pliable-polymer dental regeneration membrane, bio absorbable, ligated

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays an instrumental role in ensuring the safety, efficacy, and quality of medical products, including drugs, medical devices, and cosmetics in India. One of its primary responsibilities is issuing licenses to manufacturers, thereby regulating the production of medical devices across the country.

Manufacturing licenses act as a safeguard in the medical device industry. They ensure that manufacturers comply with industry standards to produce safe and quality products that protect patients' health and lives. In this article, we will discuss the Pliable-polymer dental regeneration membrane (bio absorbable, ligated) and the process of obtaining the CDSCO medical device manufacturing license related to it. More information and services can be accessed through the CDSCO's portal here.

What is a Pliable-polymer Dental Regeneration Membrane?

The Pliable-polymer dental regeneration membrane is a bio-absorbable material used in dental surgeries for regeneration of tooth support. This can assist in cases where tooth support has been lost due to periodontal disease or trauma, acting as a barrier during the healing period to prevent down-growth of soft tissue into the underlying bone.

The Role of CDSCO in Medical Device Regulation

Since its establishment, CDSCO has been dedicated to the protection of public health by ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices sold in the country. It works within a comprehensive regulatory framework for medical devices that combines controls, certification, and continual monitoring to ensure that all products on the market are fit for purpose and safe for use.

How to Manufacture a Pliable-Polymer Dental Regeneration Membrane

Firstly, to manufacture a pliable-polymer dental regeneration membrane, it is essential to adhere to strict manufacturing practices and protocols as delineated in the guidelines provided by the CDSCO.

Fees for Manufacturing License for a Pliable-Polymer Dental Regeneration Membrane

In line with CDSCO's classifications, a Pliable-polymer dental regeneration membrane falls under Class C medical devices, and therefore requires an MD9 license for manufacturing. The fees for this license are Rs. 50,000, with an additional Rs. 1,000 fee per product.

Why is a Manufacturing License Necessary for a Pliable-Polymer Dental Regeneration Membrane?

Obtaining manufacturing licenses is not only a legal requirement but it also emphasizes adherence to quality control standards and safety guidelines. This promotes reliability and consistency in the healthcare sector. Furthermore, licenses protect consumers and patients from substandard, illegitimate products.

Steps to Obtain a CDSCO Manufacturing license for a Pliable-Polymer Dental Regeneration Membrane

In order to obtain a CDSCO Manufacturing license, several pre-requisites need to be met. These include supplying a Device Master File, Quality Management Certificate, specific Device Details, and Site details. The application process involves submission, approval, and a thorough understanding how to overcome common challenges. More about the license obtaining process for MD9 can be found here.

Frequently Asked Questions (FAQs)

  1. Q: What is the risk class of a Pliable-polymer Dental Regeneration Membrane as per Medical Device Rules, 2017?

    • The risk class for a pliable-polymer dental regeneration membrane is class C.

  2. Q: What license is needed to manufacture a Pliable-polymer Dental Regeneration Membrane?

    • An MD9 license is required to manufacture a Pliable-polymer Dental Regeneration Membrane.

  3. Q: What is the fee for an MD9 license for a Pliable-polymer Dental Regeneration Membrane?

    • The fee for an MD9 license is Rs. 50,000, with an additional per product fee of Rs. 1,000.

  4. Q: Who will issue the manufacturing license for a Pliable-polymer Dental Regeneration Membrane?

    • The manufacturing license for class C devices, including the Pliable-polymer Dental Regeneration Membrane, will be issued by CDSCO HQ in New Delhi.

  5. Q: Is repackaging of a Pliable-polymer Dental Regeneration Membrane considered manufacturing?

    • Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and this extends to medical devices as well. Hence, repackaging of a Pliable-polymer Dental Regeneration Membrane requires an MD9 license.

Conclusion

Understanding the complexities of the medical device licensing process can be daunting. We, at Pharmadocx Consultants, can assist you in navigating this process with our expertise and experience. Do not hesitate to consult us for your licensing needs. You can reach us at: "+91-7404557227", or drop an email at: "[email protected]". Visit our website here.

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