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CDSCO Manufacturing License for Zinc polycarboxylate dental cement
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Introduction
The world of healthcare is a complex one, and it is inherently connected to the manufacturing process of various medical devices. India's Central Drugs Standard Control Organization (CDSCO) plays a key role in ensuring the quality, safety, and efficacy of these devices. CDSCO is primarily responsible for approving new medical devices, maintaining the standard of medical devices, undertaking investigations about the safety of devices, and much more.
Manufacturing licenses are a crucial part of the medical device industry. These licenses certify that the production process is in line with the legal, safety, and quality norms defined by the state. This is where the topic of our discussion, Zinc Polycarboxylate Dental Cement, comes into the picture.
Zinc Polycarboxylate Dental Cement is an important dental cement used in dental care by professionals. It serves as a luting agent, liner, or base and makes for a significant part of dental restorative procedures. To know more about CDSCO and their protocols, visit their portal here CDSCO's portal.
- What is Zinc Polycarboxylate Dental Cement?
- The Role of CDSCO in Medical Device Regulation
- How to manufacture Zinc Polycarboxylate Dental Cement
- Fees for manufacturing license for Zinc Polycarboxylate Dental Cement
- Why is a Manufacturing License Necessary for Zinc Polycarboxylate Dental Cement?
- Steps to Obtain a CDSCO Manufacturing License for Zinc Polycarboxylate Dental Cement
- Frequently Asked Questions (FAQs)
- Conclusion
What is Zinc Polycarboxylate Dental Cement?
Zinc Polycarboxylate Dental Cement is a non-sterile substance intended for dental procedures. It is a dental cement that's used as a luting agent, liner, base, or even as a direct dental restorative material. The setting of this cement is predominantly due to the hardening reaction between zinc oxide and the aqueous solutions of polycarboxylic acid, such as polyacrylic acid. This cement is commonly used in various dental procedures and is known for its efficacy and safety.
The Role of CDSCO in Medical Device Regulation
The CDSCO's foundation was laid with the specific goal of having a dedicated body that would ensure the quality and safety of drugs and medical devices in India. Their mission revolves around the certification, regulation, standardization, and safety of medical devices.
CDSCO's regulatory framework consists of numerous guidelines and regulations for medical devices, providing manufacturers with a clearly defined set of criteria and standards.
How to manufacture Zinc Polycarboxylate Dental Cement
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Fees for manufacturing license for Zinc Polycarboxylate Dental Cement
As Zinc Polycarboxylate Dental Cement falls in Class B category of medical devices, the MD5 license is required for its manufacturing. The fees for an MD5 license includes Rs. 5,000 for the license fee and Rs. 500 per product. Bear in mind these fees are subject to change as per the guidelines of CDSCO.
Why is a Manufacturing License Necessary for Zinc Polycarboxylate Dental Cement?
It is mandatory to obtain a manufacturing license to manufacture Zinc Polycarboxylate Dental Cement. This is because it ensures quality and safety standards in its production, which is critical to the healthcare sector.
Having this license signifies the manufacturer's compliance with regulatory guidelines, ensuring that consumers and patients don't fall prey to substandard products.
Steps to Obtain a CDSCO Manufacturing License for Zinc Polycarboxylate Dental Cement
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Frequently Asked Questions (FAQs)
Q. What is risk class of Zinc Polycarboxylate Dental Cement as per Medical Device Rules, 2017?
A. The risk class of Zinc Polycarboxylate Dental Cement is Class B.
Q. What license in needed to manufacture Zinc Polycarboxylate Dental Cement?
A. MD5 license is needed to manufacture Zinc Polycarboxylate Dental Cement. Link to this article- MD5 license.
Q. What is fees for MD5 license for Zinc Polycarboxylate Dental Cement?
A. The fees for MD5 license includes Rs. 5,000 for the license and Rs. 500 per product.
Q. Who will issue manufacturing license for Zinc Polycarboxylate Dental Cement?
A. For Class A sterile and measuring devices and Class B devices, the State FDA will issue the license.
Q. Is repackaging of Zinc Polycarboxylate Dental Cement considered manufacturing?
A. 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. So, repackaging of Zinc Polycarboxylate Dental Cement is also considered manufacturing requiring a license on MD5.
Conclusion
The path to obtaining a manufacturing license for Zinc Polycarboxylate Dental Cement is riddled with regulations and procedures. However, it doesn't have to be a stressful journey. Certainly not when experienced consultants like Pharmadocx Consultants, are ready to offer their assistance. The expert guidance of a seasoned consultant may prove to be invaluable in uncomplicating the process. Reach out to them via a call at +91-7404557227 or email at [email protected] for consultation or assistance regarding the licensing process.
