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CDSCO Manufacturing License for Periodontal root surface regeneration material

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is the national body of India responsible for laying the standards and regulatory measures for drugs, cosmetics, and medical devices. Medical devices, in particular, require a stringent regulatory framework due to their direct impact on patients' health and safety. Obtaining a manufacturing license is vital to ensure the quality and efficacy of these devices.

We will be discussing the Periodontal root surface regeneration material as part of this blog post. This medical device plays an integral role in dental health, particularly in the treatment and recovery from periodontal disease. The device is used during periodontal flap surgery to rejuvenate the tooth's support lost due to periodontal disease or trauma, thereby having a direct influence on the patient's overall oral health.

For more information about the regulatory framework, visit CDSCO's portal

What is Periodontal root surface regeneration material?

The Periodontal root surface regeneration material is a bio-absorbable substance applied to the root surface of a tooth during periodontal flap surgery. The substance forms an insoluble matrix that provides a conducive environment for selective cell migration and attachment, thereby restoring the tooth's lost support. It is commonly used in dental procedures to treat periodontal disease or trauma.

The Role of CDSCO in Medical Device Regulation

The CDSCO plays a pivotal role in safeguarding India's healthcare industry by establishing a strong regulatory framework for medical devices. It oversees the formulation of standards, ensures product safety, and supervises the manufacturing, sales, and distribution of medical devices in India.

How to manufacture Periodontal root surface regeneration material

The manufacturing process of Periodontal root surface regeneration material involves strict regulations and guidelines. It requires the necessary licenses offered by the CDSCO, such as MD9 for risk class C devices.

Fees for manufacturing license for Periodontal root surface regeneration material

For risk class C, as in the case of Periodontal root surface regeneration material, the appropriate license to apply for is MD9. The fees associated with MD9 are Rs. 50,000 for the license and an additional Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Periodontal root surface regeneration material?

A manufacturing license is mandatory for the production of Periodontal root surface regeneration material in accordance with the regulations of the CDSCO. The license is crucial in ensuring the quality, safety, and efficacy of the products. It also protects consumers and patients from low quality or substandard products.

Steps to Obtain a CDSCO Manufacturing License for Periodontal root surface regeneration material

  1. Prepare necessary documents such as Device Master File, Quality Management Certificate, Device Details, Site Details, etc.
  2. Submit the application online along with the necessary fees.
  3. The application will undergo review by the CDSCO.
  4. Upon approval, the manufacturing license is issued by the CDSCO headquarters.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Periodontal root surface regeneration material as per the Medical Device Rules, 2017?

The risk class of Periodontal root surface regeneration material as per the Medical Device Rules, 2017, is Class C.

Q2. What license is needed to manufacture Periodontal root surface regeneration material?

To manufacture Periodontal root surface regeneration material, you need an MD9 license.

Q3. What is the fee for an MD9 license for Periodontal root surface regeneration material?

The fee for an MD9 license for Periodontal root surface regeneration material is Rs. 50,000 for the license and Rs. 1,000 per product.

Q4. Who will issue the manufacturing license for Periodontal root surface regeneration material?

The manufacturing license for Periodontal root surface regeneration material will be issued by the CDSCO HQ in New Delhi.

Q5. Is repackaging of Periodontal root surface regeneration material considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Periodontal root surface regeneration material is also considered a drug, and hence its repackaging is also considered manufacturing, requiring an MD9 license.

Conclusion

For any in-depth clarification or consultation regarding licensing procedures, kindly reach out to our experts at Pharmadocx Consultants or dial +91-7404557227 or send an email to [email protected]. To learn more about MD9 license, visit this article.

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