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CDSCO Manufacturing License for Calcium hydroxide dental cement

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Introduction

The health industry's backbone lies in its compliance to rigid healthcare standards. Therefore, every processing step, starting from the manufacturing to the distribution of medical products and devices, must be quality-controlled. Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in regulating these measures in India. Acting as the national regulatory body for Indian pharmaceuticals and medical devices, CDSCO is dedicated to ensuring the safety, efficacy, and quality of medical products manufactured and sold in the country.

Equally critical is the manufacturing license granted by CDSCO, which acts as a mandate for entities involved in the production of medical devices. A license is a proof of compliance, a guarantee that the product aligns with health, safety, and performance requirements. Deadlines, paperwork, inspections, and fees, constitute the intricate licensing process, entrusting only committed players in the market. The significance of manufacturing licenses grows when dealing with essential medical devices, such as a Calcium hydroxide dental cement.

But let’s start by understanding the device and its significance in the medical world. For updated information and online consultations, you can visit the official CDSCO portal.

What is Calcium hydroxide dental cement?

Calcium hydroxide dental cement, a commonly used dental restorative and cementing material, is a powerfully versatile application in the realm of dentistry. It predominantly serves to promote healing and regeneration in the tooth structure during dental procedures. It is a basic compound based on the hardening reaction between calcium hydroxide and salicylic acid, which forms a long-lasting, reliable cement used in dental restoration and cavity filling.

The Role of CDSCO in Medical Device Regulation

The CDSCO came into existence to safeguard public health by ensuring the quality and safety of medical devices and pharmaceutical products. It exercises a well-defined regulatory control over the import of drugs, approval of new drugs, and clinical trials, setting standards for drugs, and coordinating the activities of State Drug Control Organizations.

To regulate the manufacture, sale, and distribution of medical devices, record-keeping, and auditing clinical trials, the CDSCO has implemented a diligent and stringent medical device regulatory framework.

How to manufacture Calcium hydroxide dental cement?

Manufacturing Calcium hydroxide dental cement involves various chemical processes that require expert handling and rigorous quality-control measures. It starts with combining the appropriate compounds in calculated proportions, followed by a series of carefully control curing and hardening stages. The entire process requires approval and monitoring by CDSCO to ensure safety and compliance.

Fees for manufacturing license for Calcium hydroxide dental cement

As Calcium hydroxide dental cement falls under risk class B, the manufacturing license required is MD5. The fees for obtaining the MD5 license are Rs 5,000, along with Rs 500 for each product.

Why is a Manufacturing License Necessary for Calcium hydroxide dental cement?

Obtaining a manufacturing license for Calcium hydroxide dental cement is mandatory as per the regulations laid out by CDSCO. This requirement roots in ensuring the production of quality and safe medical devices. It not only boosts consumer trust but also emphasises that the company is committed to high-quality standards and regulatory compliance in the healthcare sector. A license shields consumers and patients from substandard and potentially harmful products.

Steps to Obtain a CDSCO Manufacturing License for Calcium hydroxide dental cement

  1. Prepare the crucial documents required - Device Master File, Quality Management Certificate, Device Details, Site details, and others.
  2. Apply for the manufacturing license through the CDSCO portal.
  3. The application undergoes rigorous scrutiny, post which inspections are scheduled.
  4. Upon successful audit and inspection, the approval for the manufacturing license is given.

In case of any hindrances, get expert advice from Pharmadocx Consultants.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Calcium hydroxide dental cement as per Medical Device Rules, 2017?

Its risk class is B.

Q2. What license is needed to manufacture Calcium hydroxide dental cement?

The MD5 license is needed to manufacture Calcium hydroxide dental cement.

Q3. What is the fees for MD5 license for Calcium hydroxide dental cement?

A fee of Rs 5,000 for the license and Rs 500 per product is required.

Q4. Who will issue the manufacturing license for Calcium hydroxide dental cement?

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

Q5. Is repackaging of Calcium hydroxide dental cement considered manufacturing?

Yes, according to the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs and hence by extension, medical devices, is considered manufacturing. Calcium hydroxide dental cement therefore also requires a license on MD5.

Conclusion

The manufacturing licensing process, although essential for ensuring product quality and safety, can often feel overwhelming due to its complex nature. Therefore, Pharmadocx Consultants is here to provide any assistance or consultation regarding the licensing process. With our extensive experience in the field, we can aid in simplifying the procedure and streamlining your path to obtaining a manufacturing license. Feel free to reach us at Pharmadocx Consultants, call us on +91-7404557227 or email us on [email protected].

We also advise you to explore more about the MD5 license on our blog touching upon MD-5 License Class A&B Medical Devices. Stay tuned to our blog for more detailed information and guidance about medical device regulation in India.

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