Published on

CDSCO Manufacturing License for Dental bone matrix implant, animal-derived

Authors
  • avatar
    Name
    CDSCO Licenses Blog
    Twitter

Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's principal regulatory body overseeing drug safety and quality. Its key responsibilities extend to laying down the standards and protocols for manufacturing, selling, and distributing a wide range of health and personal care products - including medical devices. Manufacturing licenses are one of the main regulatory tools to ensure compliance with these standards, particularly within the medical device industry.

In the spotlight today is the 'Dental bone matrix implant, animal-derived', a remarkable piece of medical technology that has substantial implications in the field of dental care. Specifically designed for maxillofacial and mandibular bone reconstruction or augmentation, these implants play a critical role in restoring functional and aesthetic aspects after trauma or dental surgery.

You can learn more about licensing and other CDSCO regulatory aspects on their official portal.

What is Dental Bone Matrix Implant, Animal-Derived?

A dental bone matrix implant, animal-derived, is an osteoconductive device made predominantly from animal-derived bone or dentin matrix. The implant is sterile and bio-absorbable, strategically designed to fill bone cavities and defects. Functioning as a scaffold, this implant helps to reconstruct lost bone tissue caused by trauma or after dental surgery.

The Role of CDSCO in Medical Device Regulation

The CDSCO’s history and mission align with its pivotal role in ensuring public health safety by standardizing and controlling the quality of drugs—including medical devices—in India. The regulatory body's framework for medical devices is comprehensive and puts much emphasis on risk-based classification, manufacturing licenses, and post-marketing surveillance.

How to manufacture Dental Bone Matrix Implant, Animal-Derived

The manufacturing process of the Dental Bone Matrix Implant, animal-derived, involves multiple stages from extraction and processing of the animal bone material to sterilization and packaging. Each stage needs to adhere to stringent quality controls as part of the CDSCO requirements.

Fees for manufacturing license for Dental Bone Matrix Implant, Animal-Derived

Given the Dental Bone Matrix Implant, animal-derived, falls under the risk class C, the license applicable is MD9. The fees for the license is Rs.50,000 and an additional Rs.1,000 per product.

Why is a Manufacturing License Necessary for Dental Bone Matrix Implant, Animal-Derived?

Having a manufacturing license for medical devices such as the Dental Bone Matrix Implant, animal-derived, is not only a legal requirement but crucial to ensure safety and quality. Regulatory compliance in the healthcare sector not only maintains standards but also builds patient and stakeholder trust, keeping substandard products at bay.

Steps to Obtain a CDSCO Manufacturing License for Dental Bone Matrix Implant, Animal-Derived

  1. Gather all prerequisite documents like Device Master File, Quality Management Certificate, Device Details, and Site Details.
  2. Submit your application thoroughly filled and attached with all required documents.
  3. Monitor the process until approval, resolving any challenges encountered.
  4. Obtain the license and keep it up to date.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of a Dental Bone Matrix Implant, Animal-Derived, as per Medical Device Rules, 2017?

The Dental Bone Matrix Implant, Animal-Derived, falls under risk class C.

Q2. What license is needed to manufacture Dental Bone Matrix Implant, Animal-Derived?

The MD9 license is required to manufacture Dental Bone Matrix Implants, Animal-Derived.

Q3. What is the fee for an MD9 license for Dental Bone Matrix Implant, Animal-Derived?

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

Q4. Who will issue a manufacturing license for a Dental Bone Matrix Implant, Animal-Derived?

CDSCO HQ in New Delhi will issue the license.

Q5. Is repackaging of Dental Bone Matrix Implant, Animal-Derived considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing, and by extension, medical devices too are considered drugs. Hence, repackaged Dental Bone Matrix Implants, Animal-Derived require an MD9 license.

Conclusion

Securing a CDSCO license, while a challenging process, is necessary for producing quality and safe medical devices. For consulting and assistance throughout the licensing process and more, reach out to Pharmadocx Consultants, contact via email at "[email protected]" or call at "+91-7404557227". For details on the MD9 licensing process, visit this this article.

cdsco import license in india banner
cdsco manufacturing license in india banner