Published on

CDSCO Manufacturing License for Dental surgical procedure kit, medicated, reusable

Authors
  • avatar
    Name
    CDSCO Licenses Blog
    Twitter

Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's chief regulatory body for pharmaceuticals and medical devices. It is entrusted with ensuring the safety, efficacy and quality of drugs, cosmetics and medical devices available to the Indian population and is responsible for regulating the manufacturing, importing, conducting clinical trials, quality control, and distribution of these items nationwide.

Manufacturing licenses play a pivotal role in the medical device industry. This certification ensures that these life-saving products meet the highest quality and safety standards. A manufacturing license assures the end-user that the device has been produced under stringent guidelines to guarantee its efficiency and safety.

Our focus today will be on the dental surgical procedure kit, medicated, reusable, a Class C medical device defined by its significant contribution to dental health care. This kit plays an indispensable role in dental surgical procedures, enhancing the effectiveness and safety of these operations.

To understand more about the CDSCO and the manufacturing licenses it issues, visit their official portal here.

What is Dental surgical procedure kit, medicated, reusable?

This Class C medical device is a comprehensive collection of varied dental instruments, pharmaceutical dressings, and other necessary materials required to effectively perform a dental surgical procedure. The main purpose of this kit is to provide dentists with the required tools and medications to carry out successful dental surgeries, consequently improving dental health outcomes for patients.

The Role of CDSCO in Medical Device Regulation

The CDSCO ensures the regulation of medical devices, including the Dental surgical procedure kit, medicated, reusable. Over the years, CDSCO's mission has evolved to provide efficient control over the manufacturing and distribution of medical devices following international norms. Their broad regulatory framework covers all aspects of medical devices, from classification to manufacturing and marketing approval, ensuring the utmost safety for Indian consumers.

How to manufacture Dental surgical procedure kit, medicated, reusable

To manufacture this Class C device, the producer is required to follow a set of standards put forth by the CDSCO. These standards are designed to ensure that the reusable dental surgical procedure kits are safe, effective, and hold medicinal value.

Fees for manufacturing license for Dental surgical procedure kit, medicated, reusable

The license to manufacture Class C medical devices, such as the Dental surgical procedure kit, medicated, reusable, involves a fee of Rs. 50,000 for the license, and an additional Rs. 1,000 per product. Please find additional information on the license here.

Why is a Manufacturing License Necessary for Dental surgical procedure kit, medicated, reusable?

A manufacturing license is mandatory for the production of this Class C medical device. These licenses ensure that the producers adhere to the quality and safety standards laid down by the regulatory bodies. Adequate safety and quality checks in medical device production protect patients and consumers from substandard products, ensuring their health and safety. Compliance to these regulations is also a hallmark of a responsible participant in the healthcare sector.

Steps to Obtain a CDSCO Manufacturing License for Dental surgical procedure kit, medicated, reusable

To acquire a CDSCO license for manufacturing, a set of pre-requisites and documentation is required. This includes a Device Master File, Quality Management Certificate, Device Details, Site Details, etc. After this, the application process ensues, leading from submission to approval. There can be common challenges along the way, but with the right guidance, they can be easily overcome.

Frequently Asked Questions (FAQs)

Q1: What is the risk class of Dental surgical procedure kit, medicated, reusable, as per Medical Device Rules, 2017?

The Dental surgical procedure kit, medicated, reusable, falls under Class C as per Medical Device Rules, 2017.

Q2: What license is needed to manufacture Dental surgical procedure kit, medicated, reusable?

To manufacture the Dental surgical procedure kit, medicated, reusable, an MD9 license is required.

Q3: What is the fees for MD9 license for Dental surgical procedure kit, medicated, reusable?

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

Q4: Who will issue the manufacturing license for Dental surgical procedure kit, medicated, reusable?

The CDSCO HQ in New Delhi will issue the MD9 license for Class C devices like the Dental surgical procedure kit, medicated, reusable.

Q5: Is repackaging of Dental surgical procedure kit, medicated, reusable considered manufacturing?

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. Hence, repackaging of the Dental surgical procedure kit, medicated, reusable also requires an MD9 license.

Conclusion

Navigating the regulatory landscape for medical device manufacturing can be complex. Our knowledgeable consultants at Pharmadocx Consultants are available to guide you through the licensing process. For further consultation or assistance on obtaining the right manufacturing license for your medical device, call us directly on +91-7404557227, or email us at [email protected]. Together, we can ensure your medical device meets the regulatory standards and reaches those who need it most.

cdsco import license in india banner
cdsco manufacturing license in india banner