CDSCO Manufacturing License for Single-use dermatome blade

Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's premier national regulatory body for pharmaceuticals and medical devices. Governed by the Ministry of Health & Family Welfare, CDSCO is responsible for standardization and quality control of medicines, vaccines and medical devices in India.

In the medical devices industry, manufacturing licenses play a crucial role. It ensures both the safety and the quality of the devices that directly or indirectly affect human life. One such essential medical device is the Single-use dermatome blade.

The Single-use dermatome blade, intended for collection of skin grafts in dermatological and plastic surgery procedures, is an essential tool in the medical field. You can access more information on CDSCO portal

What is a Single-use Dermatome Blade?
The Role of CDSCO in Medical Device Regulation
How to manufacture Single-use Dermatome Blade
Fees for manufacturing license for Single-use Dermatome Blade
Why is a Manufacturing License Necessary for Single-use Dermatome Blade?
Steps to Obtain a CDSCO Manufacturing License for Single-use Dermatome Blade
Frequently Asked Questions (FAQs)
Conclusion

What is a Single-use Dermatome Blade?

A Single-use Dermatome Blade is a sharp device used for collecting skin grafts. It is specifically designed for one-time use to prevent cross-contamination, hence promoting hygiene and patient safety in medical procedures.

Common procedures where the Single-use Dermatome Blade finds application are skin transplantation surgeries and burn injury treatments. These blades are available in various sizes to meet the specific requirements of the surgical operation.

The Role of CDSCO in Medical Device Regulation

CDSCO's mission is to safeguard and enhance public health by assuring safety, efficacy and quality of drugs, cosmetics and medical devices. Over the years, CDSCO has played a significant role in regulating the medical device industry in India through a robust regulatory framework.

Considering the importance of patient safety and product quality, the regulatory framework developed by CDSCO is rigid, requiring stringent compliance to regulatory processes, product standards, and quality norms.

How to manufacture Single-use Dermatome Blade

The manufacturing of Single-use Dermatome Blade involves specialized production techniques and machinery, adhering to the safety regulations and standards. Manufacturers also need to follow a streamlined process to ensure quality control and maintain sterility due to its intended use.

Fees for manufacturing license for Single-use Dermatome Blade

For manufacturing a Single-use Dermatome Blade, which belongs to the Class B medical device category, an MD5 license is required. The fees for this license is Rs. 5,000, with an additional Rs. 500 per product. You can get more information on MD5 License on this page

Why is a Manufacturing License Necessary for Single-use Dermatome Blade?

Obtaining a manufacturing license is mandatory for Single-use Dermatome Blade. This license ensures:

Quality and safety of the medical device
Regulatory compliance in the healthcare sector
Protection for consumers and patients from substandard products

Steps to Obtain a CDSCO Manufacturing License for Single-use Dermatome Blade

Prepare necessary documents including Device Master File, Quality Management Certificate, Device Details, Site details etc.
Submit the application for license with the aforementioned documents.
Await approval from the regulatory body.
Overcome challenges, if any, with suitable strategies and compliance.

Frequently Asked Questions (FAQs)

Q.1. What is risk class of Single-use Dermatome Blade as per Medical Device Rules, 2017?

The Single-use Dermatome Blade falls under Risk Class B.

Q.2. What license is needed to manufacture Single-use Dermatome Blade?

For manufacturing Single-use Dermatome Blade, an MD5 license is needed.

Q.3. What is fees for MD5 license for Single-use Dermatome Blade?

The fees for MD5 license for Single-use Dermatome Blade is Rs. 5,000 for the license and an additional charge of Rs. 500 per product.

Q.4. Who will issue manufacturing license for Single-use Dermatome Blade?

The state FDA will issue the manufacturing license for Class B devices like Single-use Dermatome Blade.

Q.5. Is repackaging of Single-use Dermatome Blade 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. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of Single-use Dermatome Blade is also considered manufacturing requiring a license on MD5.

Conclusion

Completing the licensing process and fulfilling the regulatory requirements can be a daunting task. However, with the help of experts like us at Pharmadocx Consultants, you can navigate through this process with ease. Whether you need consultation or assistance with your licensing application, we're here to help. You can reach us at our website, call us at +91-7404557227, or email us at [email protected].