CDSCO Manufacturing License for Dental surgical procedure kit, medicated, single-use

Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's pinnacle regulatory body for medical drugs and devices, akin to the FDA in the United States. Under the Ministry of Health and Family Welfare, Government of India, it is tasked with the approval of new drugs, laying down safety standards, control over drug quality, import-export inspection, and clinical trials.

Manufacturing licenses bear paramount importance in the medical device industry. Beyond being a legal prerequisite, it is a badge of reliability, implying that the product has undergone rigorous quality control and safety checks.

Today, we will delve deeper into a critical tool of the dental healthcare industry - the Dental surgical procedure kit, medicated, single-use. An essential device for oral surgical procedures, let’s understand its significant role in our healthcare system. To peruse additional information or explore a multitude of other medical devices, visit CDSCO's portal at https://cdscomdonline.gov.in/NewMedDev/Homepage

• What is Dental surgical procedure kit, medicated, single-use?
• The Role of CDSCO in Medical Device Regulation
• How to manufacture Dental Surgical Procedure Kit, medicated, single-use
• Fees for manufacturing license for Dental Surgical Procedure Kit, medicated, single-use
• Why is a Manufacturing License Necessary for Dental Surgical Procedure Kit, medicated, single-use?
• Steps to Obtain a CDSCO Manufacturing License for Dental Surgical Procedure Kit, medicated, single-use
• Frequently Asked Questions (FAQs)
• Conclusion

What is Dental surgical procedure kit, medicated, single-use?

The Dental surgical procedure kit, medicated, single-use, in essence, is a collection of various dental instruments, medications, dressings, and materials needed for conducting a dental surgical procedure. It is specially curated for single use to assure sterility and avoid cross-contamination.

Common uses of this kit include procedures like dental extractions, root canal treatments, implant surgeries, and treatment of gum diseases. The kit's single-use characteristic is a robust infection control measure, stemming from healthcare's fundamental principle - "First, do no harm."

The Role of CDSCO in Medical Device Regulation

CDSCO has a rich history in safeguarding and enhancing public health in India. Its mission is to ensure safe and effective medical drugs and devices to citizens. Being highly cognizant of its role, CDSCO has created an exhaustive regulatory framework for medical devices.

This regulation represents an ardent effort towards fostering a reliable healthcare ecosystem, anchored in quality and safety.

How to manufacture Dental Surgical Procedure Kit, medicated, single-use

Abiding by CDSCO's guidance, necessary steps must be meticulously followed to ensure the safe manufacturing of the Dental Surgical Procedure Kit. These steps, being multi-faceted, encompass technical, quality, and regulatory aspects, interwoven into the manufacturing process.

Fees for manufacturing license for Dental Surgical Procedure Kit, medicated, single-use

Pertaining to its risk class C, the license required is MD9; hence, the fee for the manufacturing license is Rs. 50,000 and an additional Rs.1,000 per product.

Why is a Manufacturing License Necessary for Dental Surgical Procedure Kit, medicated, single-use?

Acquiring a Manufacturing License is mandatory and ensures quality and safety during the manufacturing process. Regulatory compliance of this nature plays an integral role in the healthcare sector. It primarily safeguards consumers and patients from substandard medical device products.

Steps to Obtain a CDSCO Manufacturing License for Dental Surgical Procedure Kit, medicated, single-use

To obtain a CDSCO manufacturing license, certain pre-requisites and documentation are required which include, but are not limited to, Device Master File, Quality Management Certificate, Device Details, Site Details, and more.

The application process begins with submission and ends with approval, with potential challenges that may arise during the journey. It is essential to have a thorough understanding and meticulous precision to overcome these points of hurdles.

For a comprehensive view regarding the license procedure for Class C devices, refer to this article here.

Frequently Asked Questions (FAQs)

1. Q: What is the risk class of Dental Surgical Procedure Kit, medicated, single-use as per Medical Device Rules, 2017?

   A: The risk class for Dental Surgical Procedure Kit, medicated, single-use is Class C.

2. Q: What license is needed to manufacture Dental Surgical Procedure Kit, medicated, single-use?

   A: To manufacture Dental Surgical Procedure Kit, medicated, single-use, an MD9 license is required.

3. Q: What is the fee for the MD9 license for Dental Surgical Procedure Kit, medicated, single-use?

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

4. Q: Who will issue the manufacturing license for Dental Surgical Procedure Kit, medicated, single-use?

   A: For Class C devices like Dental Surgical Procedure Kit, medicated, single-use, the license is issued by the CDSCO HQ in New Delhi.

5. Q: Is repackaging of Dental Surgical Procedure Kit, medicated, single-use considered manufacturing?

   A: Yes, the Drugs and Cosmetics Act's definition of manufacturing includes repackaging of drugs. Medical devices also fall under the Act's jurisdiction, and hence repackaging of Dental Surgical Procedure Kit, medicated, single-use is also considered manufacturing and requires an MD9 license.

Conclusion

Understanding the process of obtaining manufacturing licenses can be complex. Thus, you may need professional help navigating the nuances. If you have further inquiries or need help with the license process, feel free to reach out to our experienced team. You can consult with Pharmadocx Consultants at "https://www.pharmadocx.com", call at +91-7404557227, or you can email your inquiries to "[email protected]".