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CDSCO Manufacturing License for Dental crown, polymer

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India’s main regulatory body vested with the responsibility for regulating and supervising the quality of drugs, vaccines, and medical devices. The regulatory body plays a pivotal role in protecting and promoting public health via ensuring safe and effective medical products and therapies. CDSCO uses scientific standards and a risk-based approach to regulate the vast healthcare industry including medical devices.

In the medical device industry, manufacturing licenses are vital for standardizing the production and distribution of life-saving devices. These licenses pave the way for high-quality and efficient medical devices that prove crucial in medical and surgical procedures. A particular medical device we would focus on in this discussion is the Dental Crown, Polymer. This tool forms an integral part of dentistry and oral health procedures. More information on the Dental Crown, Polymer and related topics can be found on CDSCO's portal here.

What is a Dental Crown, Polymer?

A Dental Crown, Polymer is an artificial dental prosthetic made from polymer-based material, either reinforced with fiber or devoid of it. This device is custom-made for a specific patient to function as a substitute for the major part or the whole part of the clinical crown of a tooth. Taking its significance into account, these crowns are commonly used in various dental procedures ranging from cosmetic to restorative dentistry.

The Role of CDSCO in Medical Device Regulation

CDSCO, over decades, has been instrumental in formulating strategic policies and regulations for medical devices. The regulatory body’s key role lies in implementing the Medical Device Rules (MDR), warranting the safety and effectiveness of medical devices. Within this regulatory framework, different risk classes (Class A - lowest risk, Class D - highest risk) and respective licenses (Class A and B - MD5, Class C and D - MD9) are comprehensively outlined.

How to manufacture a Dental Crown, Polymer

The fabrication of a Dental Crown, Polymer involves a meticulous procedure of modeling and fabrication. Offering personalized solutions, these crowns have to be crafted individually for each patient considering the specific requirements of their oral health. All the processes involved follow a stringent set of rules and regulations as mandated by the CDSCO.

Fees for manufacturing license for a Dental Crown, Polymer

Considering a Dental Crown, Polymer falls under the Class B risk factor, the manufacturing license required is MD5. The fees for obtaining an MD5 license is Rs. 5,000 and an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for a Dental Crown, Polymer?

A manufacturing license is obligatory to ensure that the Dental Crown, Polymer is produced according to established safety standards and regulations. This is key to guaranteeing quality and safety in medical device production. Regulatory compliance further plays a massive role in the healthcare sector, protecting consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for a Dental Crown, Polymer

  1. Preparation of Device Master File, Quality Management Certificate, and Site details
  2. Submission of the documents and application
  3. Regulatory evaluation and approval
  4. Overcome common challenges through thorough preparation and compliance

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Dental Crown, Polymer as per Medical Device Rules, 2017?

A1. The risk class of Dental Crown, Polymer is Class B.

Q2. What license is needed to manufacture a Dental Crown, Polymer?

A2. The manufacturing license required for a Dental Crown, Polymer is MD5.

Q3. What are the fees for an MD5 license for a Dental Crown, Polymer?

A3. The fees for an MD5 license for a Dental Crown, Polymer are Rs. 5,000 for the license and an additional Rs. 500 per product.

Q4. Who will issue a manufacturing license for a Dental Crown, Polymer?

A4. For Class A sterile and measuring devices & class B devices, the state FDA will issue the license.

Q5. Is repackaging of a Dental Crown, Polymer considered manufacturing?

A5. Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Medical Device Rules have been made under the provisions of the Drug Act only and hence repackaging of a Dental Crown, Polymer is also considered manufacturing requiring a license of MD5.

Conclusion

For more details about the licensing process and to get professional assistance, feel free to reach out to Pharmadocx Consultants. Feel free to call us at +91-7404557227 or send an email to [email protected]. We are here to help bring your medical device to market safely and efficiently.

If you need more details on the procedure to obtain the MD5 license for Class A and Class B medical devices, you can check out this article.

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