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CDSCO Manufacturing License for Bone matrix implant, human-derived

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Introduction

The Central Drugs Standard Control Organization, also known as CDSCO, signifies a vital part of the healthcare sector in India, acting as a crucial regulatory body of the Indian pharmaceuticals and medical device industry. Its prime responsibilities include controlling the quality of drugs and medical devices, ensuring safety, effectiveness and adherence to the highest standards in these areas. Manufacturing licenses play a critical role in the medical device industry, guaranteeing that companies are complying with essential regulations and guidelines, thereby ensuring public safety and maintaining confidence in healthcare.

This article will focus on the Bone Matrix Implant, Human-Derived – a remarkable tool with profound significance in the medical arena. Developed primarily from human demineralized bone matrix (DBM), this implantable device is specifically designed to fill bony voids or gaps resulting from trauma or medical procedures, including its usage in the maxillofacial and/or mandibular bone.

For those interested in more detailed information about CDSCO and regulations concerning the production and distribution of medical devices, the CDSCO's portal here is an invaluable resource.

What is Bone Matrix Implant, Human-Derived?

Bone Matrix Implant, human-derived, is a device engineered primarily from human demineralized bone matrix (DBM). Functioning as an osteoconductive framework, it is utilized to fill bony defects or gaps caused by trauma or surgical procedures. Common uses involve areas like oral and maxillofacial surgery, orthopedic and spine procedures, where it aids in triggering new bone formation and promoting natural bone healing.

The Role of CDSCO in Medical Device Regulation

As a paramount regulatory force in India's healthcare sector, CDSCO maintains a comprehensive framework for the regulation of medical devices. Its mission is to safeguard and enhance public health by ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices. CDSCO carries the responsibility of managing manufacturing licenses, overseeing clinical investigations, and conducting post-market surveillance, to ensure products' safety and compliance.

How to manufacture Bone Matrix Implant, Human-Derived

The manufacturing process of Bone Matrix Implant, Human-Derived entails several steps that require strict adherence to pertinent guidelines and regulations set by CDSCO. These procedures ensure the production of quality devices that can efficiently serve their intended purpose without posing any health risks. The meticulous process requires a Class C license (MD9) from CDSCO, ensuring that the production is well-regulated.

Fees for manufacturing license for Bone Matrix Implant, Human-Derived

As Bone Matrix Implant, Human-Derived is classified as a Class C device, it requires an MD9 license. The costs associated with an MD9 license are Rs. 50,000 for the license and an additional Rs. 1,000 per product. More details on how to obtain an MD9 license can be found here.

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

Acquiring a manufacturing license is essential for ensuring the safety and quality of the produced devices. It upholds regulatory compliance in the healthcare sector and safeguards patients and consumers from substandard products. For Class C devices like the Bone Matrix Implant, Human-Derived, it is mandatory to possess an MD9 license.

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

The process of obtaining a CDSCO manufacturing license can be summarized in four key steps.

  1. Gather and prepare all required documents, including Device Master File, Quality Management Certificate, Device Details, Site details, among others.

  2. Submit the completed application form and required documents to CDSCO.

  3. Wait for the review process, during which the CDSCO may ask for additional information or verification.

  4. Once approved, the applicant will receive the manufacturing license.

Frequently Asked Questions (FAQs)

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

Bone Matrix Implant, Human-Derived is classified as a Class C device as per the Medical Device Rules, 2017.

Q2. What license is needed to manufacture a Bone Matrix Implant, Human-Derived?

MD9 license is needed to manufacture a Bone Matrix Implant, Human-Derived.

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

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

Q4. Who will issue the manufacturing license for Bone Matrix Implant, Human-Derived?

The manufacturing license for Bone Matrix Implant, Human-Derived (Class C device) will be issued by the CDSCO HQ in New Delhi.

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

Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by further definitions, medical devices are also drugs. The Medical Device Rules have been made under the provisions of the Drug Act only and hence repackaging of Bone Matrix Implant, Human-Derived is also considered manufacturing requiring an MD9 license.

Conclusion

Navigating through the CDSCO medical device regulations and obtaining the appropriate manufacturing licenses can seem daunting. Expert guidance from seasoned professionals can simplify this process considerably. At Pharmadocx Consultants, you can find advice and assistance that can help streamlining your journey towards gaining the required manufacturing licenses. For a detailed and personalized consultation, you can get in touch via "+91-7404557227" or write us at "[email protected]" . Don't hesitate! We are here to provide the solutions that you need.

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