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CDSCO Manufacturing License for Dental soft-tissue matrix implant, animal-derived

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is the cornerstone of regulation in India's healthcare sector, primarily responsible for the approval and monitoring of new drugs and standards for drugs, control over the quality of imported drugs, coordination of state FDA's activities and providing guidance to them, and taking up other responsibilities as assigned from time to time.

In the area of medical devices, CDSCO plays a pivotal role, ensuring that all devices manufactured and sold in India comply with global safety and quality standards. Of all the items in its purview, one that deserves particular attention is the Dental soft-tissue matrix implant, animal-derived.

Dental soft-tissue matrix implants, especially those derived from animals, play a significant role in promoting the re-growth of lost oral tissues, thereby facilitating better oral health for patients.

Feel free to explore more about the Dental soft-tissue matrix implant on CDSCO's portal here.

What is a Dental Soft-Tissue Matrix Implant, Animal-Derived?

A Dental Soft-Tissue Matrix Implant, Animal-Derived, is collagen-based bio-absorbable implant ideally made from animal by-products, specifically, porcine. The primary function of these implants is to foster the regeneration of oral soft tissue lost due to periodontal diseases or trauma. They are especially useful in carrying out various oral soft tissue augmentation procedures, including alveolar ridge reconstruction and gingival augmentation.

The Role of CDSCO in Medical Device Regulation

The Central Drugs Standard Control Organization (CDSCO) serves as the authority safeguarding and regulating the quality of medical devices in India. It follows a strong regulatory framework for medical device qualification, monitoring adherence to established international quality standards, and carrying out requisite actions in case of non-compliance.

How to Manufacture a Dental Soft-Tissue Matrix Implant, Animal-Derived

Manufacturing a Dental Soft-Tissue Matrix Implant, Animal-Derived, requires meticulous conditions and systems in place, especially as it is classified under class C risk category. Manufacturing such a device requires adherence to specific regulated procedures.

Fees for Manufacturing License for Dental Soft-Tissue Matrix Implant

Given its placement in the Class C risk category, the manufacturing cost of the Dental Soft-Tissue Matrix Implant, Animal-Derived, is Rs. 50,000 for the license and Rs. 1,000 per product under the MD9 license.

Why is a Manufacturing License Necessary for Dental Soft-Tissue Matrix Implant?

Given the significant role a Dental Soft-Tissue Matrix Implant plays in patient safety and recovery, it is imperative that manufactures obtain the necessary MD9 manufacturing license. This licensure ensures the product meets CDSCO's stringent quality and safety standards and regulatory compliance in the healthcare sector. This is crucial to protect consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for a Dental Soft-Tissue Matrix Implant

  1. Prepare necessary documents, including Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submit the required documentation and application to CDSCO.
  3. Await CDSCO's review and subsequent approval or disapproval.
  4. Overcome any challenges or objections raised by CDSCO.

Frequently Asked Questions (FAQs)

  1. Q. What is the risk class of Dental Soft-Tissue Matrix Implant, Animal-Derived, as per Medical Device Rules, 2017?
    A. The Dental Soft-Tissue Matrix Implant, Animal-Derived, falls under the Class C risk category as per Medical Device Rules, 2017.

  2. Q. What license is needed to manufacture Dental Soft-Tissue Matrix Implant, Animal-Derived?
    A. The necessary license for manufacturing Dental Soft-Tissue Matrix Implant, Animal-Derived is MD9.

  3. Q. What is the fee for MD9 license for Dental Soft-Tissue Matrix Implant, Animal-Derived?
    A. The fee for the MD9 license for Dental Soft-Tissue Matrix Implant, Animal-Derived is Rs.50,000 for the license and Rs.1,000 per product.

  4. Q. Who will issue the manufacturing license for Dental Soft-Tissue Matrix Implant, Animal-Derived?
    A. The CDSCO Headquarters in New Delhi will issue the manufacturing license for Dental Soft-Tissue Matrix Implant, Animal-Derived.

  5. Q. Is repackaging of Dental Soft-Tissue Matrix Implant, Animal-Derived considered manufacturing?
    A. Yes, as per the 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 Dental Soft-Tissue Matrix Implant, Animal-Derived is also considered manufacturing requiring a license on MD9.

Conclusion

Navigating the regulations and requirements for manufacturing your Medical Device can be complex. For expert guidance and assistance in obtaining a CDSCO Manufacturing License for Dental Soft-Tissue Matrix Implant, Animal-Derived, feel free to reach out to Pharmadocx Consultants. Visit us at www.pharmadocx.com, call us at +91-7404557227, or email us at [email protected]. To know more about the MD9 license, follow this link.

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