CDSCO Manufacturing License for Copper vapour laser

Introduction

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices. It is the apex drug authority acting under the Ministry of Health and Family Welfare, Government of India. The significant functions of CDSCO include the regulation of the quality of drugs, clinical trials approval, importing and exporting of drugs, inspecting and enforcing good manufacturing practices, etc.

In the Indian health industry, manufacturing licenses play a crucial role, especially in the medical device sector. It ensures that the medical devices produced meet the required safety and quality standards and are efficacious for their intended use. One such medical device of significant medical importance is the Copper Vapour Laser.

Copper Vapour Laser is extensively used in surgical procedures, particularly in dermatological treatments such as treatment of cutaneous vascular lesions. Regulations and licenses related to the manufacturing of Copper Vapour Laser are taken care of by CDSCO. All information related to the licenses can be accessed via CDSCO's official portal here.

• What is Copper Vapour Laser?
• The Role of CDSCO in Medical Device Regulation
• How to manufacture Copper Vapour Laser
• Fees for manufacturing license for Copper Vapour Laser
• Why is a Manufacturing License Necessary for Copper Vapour Laser?
• Steps to Obtain a CDSCO Manufacturing License for Copper Vapour Laser
• Frequently Asked Questions (FAQs)
• Conclusion

What is Copper Vapour Laser?

Copper Vapour Laser is a type of gas laser that leverages copper vapor as the substrate. It is typically used in surgical procedures and dermatology treatments for cutaneous vascular lesions (e.g., port-wine stains, telangiectasia). The laser light emitted by a copper vapour laser is yellow-green, which can penetrate skin tissue without causing thermal injury.

The Role of CDSCO in Medical Device Regulation

CDSCO has a rich history in ensuring the quality and effectiveness of medical devices and drugs in India. It plays a significant role in the regulation of medical devices, including Copper Vapour Lasers. Their regulatory framework for medical devices revolves around providing the best healthcare facilities to Indian citizens while maintaining the standards of medical devices across the country.

Link to complete details of CDSCO

How to manufacture Copper Vapour Laser

Fees for manufacturing license for Copper Vapour Laser

Copper Vapour Laser falls under Risk Class C. Thus, the required manufacturing license is MD9. The fees for the MD9 license are Rs. 50,000 for the license and Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Copper Vapour Laser?

The manufacturing license is mandatory to ensure the production of medical devices adheres to the guidelines set by CDSCO. The license guarantees that medical devices being produced adhere to the quality and safety standards specified by the Drugs and Cosmetics Act. Regulatory compliance plays a significant role in protecting patients and consumers from substandard or dangerous products.

Link to complete details about CDSCO MD9 licensing

Steps to Obtain a CDSCO Manufacturing License for Copper Vapour Laser

1. Prepare the required documents such as Device Master File, Quality Management Certificate, Device Details, Site details, etc.

2. Submit the completed application to CDSCO HQ in New Delhi.

3. Await approval from the authorities.

4. Once approved, obtain the manufacturing license.

Frequently Asked Questions (FAQs)

1. What is the risk class of Copper Vapour Laser as per Medical Device Rules, 2017?

   Copper Vapour Laser falls under the Risk Class C as per Medical Device Rules, 2017.

2. What license is needed to manufacture Copper Vapour Laser?

   The manufacturing license required for Copper Vapour Laser is MD9.

3. What is the fees for MD9 license for Copper Vapour Laser?

   The fees for the MD9 license are Rs. 50,000 for the license and Rs. 1,000 per product.

4. Who will issue the manufacturing license for Copper Vapour Laser?

   For Copper Vapour Laser (Class C device), the manufacturing license will be issued by the CDSCO HQ in New Delhi.

5. Is repackaging of Copper Vapour Laser considered manufacturing?

   Yes, as per the Drugs and Cosmetics Act's definition, repackaging of drugs is considered manufacturing. Medical devices are also considered as drugs under this Act. Hence, repackaging of Copper Vapour Laser is also considered manufacturing and requires a license, in this case, MD9.

Conclusion

Securing a CDSCO Manufacturing License for medical devices, such as the Copper Vapour Laser, is a crucial step in providing safe, effective medical treatments to the populace. We encourage practitioners to contact Pharmadocx Consultants for assistance regarding the licensing process and to facilitate the manufacture of quality medical devices. Contact us at Pharmadocx Consultants, call us on +91-7404557227 or drop an email to [email protected] for further assistance.