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CDSCO Manufacturing License for TEM/TEO rectoscope, optical

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's central regulatory body for pharmaceuticals and medical devices. Within the healthcare sector, manufacturing licenses play a crucial role, ensuring the production and distribution of safe, efficient medical products.

Today, we'll focus on the TEM/TEO rectoscope, optical, a Class B risk medical device employed during transanal endoscopic microsurgery or transanal endoscopic operations. Understanding the importance of licenses like MD5 needed to manufacture this device can lead to robust healthcare delivery. For more information, visit the CDSCO portal here.

What is TEM/TEO Rectoscope, Optical?

A TEM/TEO rectoscope, optical, is an endoscope with a rigid inserted portion. It is specifically designed for surgical treatment of the lower part of the bowel during transanal endoscopic microsurgery (TEM) or transanal endoscopic operations (TEO). Its use enables surgeons to visualize and operate on the rectal wall with great precision.

The Role of CDSCO in Medical Device Regulation

CDSCO under the Ministry of Health and Family Welfare regulates the safety, efficacy, and quality of medical devices in India. It has a comprehensive regulatory framework that ensures all medical devices, such as the TEM/TEO rectoscope, optical, meet the highest safety and performance standards.

How to Manufacture TEM/TEO Rectoscope, Optical

Manufacturing a TEM/TEO rectoscope, optical, requires precision and adherence to strict quality control regulations. A manufacturing license issued by CDSCO is required to ensure that the fabricated device satisfies all safety and performance measures.

Fees for Manufacturing License for TEM/TEO Rectoscope, Optical

For Class B devices like the TEM/TEO rectoscope, optical, an MD5 license is required. The fees for an MD5 license include Rs. 5,000 for the license and Rs. 500 per product. For more information, click here.

Why is a Manufacturing License Necessary for TEM/TEO Rectoscope, Optical?

It is mandatory to acquire a license to manufacture devices like the TEM/TEO rectoscope, optical. This license is not just a formal requirement, but it also stands as a guarantee of product quality and safety. Regulatory compliance is vital in the healthcare sector, protecting consumers and patients from inferior or harmful products.

Steps to Obtain a CDSCO Manufacturing License for TEM/TEO Rectoscope, Optical

  1. Gather necessary documentation, which may include Device Master File, Quality Management Certificate, Device Details, and Site details.
  2. Submit your application to the respective authority.
  3. Await review and approval of your application.
  4. Address any challenges that arise, backed by expert consultation and proactive problem-solving.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of TEM/TEO Rectoscope, Optical as per Medical Device Rules, 2017?

  • The risk class of TEM/TEO Rectoscope, Optical is Class B.

Q2. What license is needed to manufacture TEM/TEO Rectoscope, Optical?

  • An MD5 license is required to manufacture TEM/TEO Rectoscope, Optical.

Q3. What is the fee for an MD5 license for the TEM/TEO Rectoscope, Optical?

  • The fee for an MD5 license is Rs. 5,000 plus Rs. 500 per product.

Q4. Who will issue the manufacturing license for a TEM/TEO Rectoscope, Optical?

  • For Class B devices like the TEM/TEO Rectoscope, Optical, the state FDA issues the manufacturing license.

Q5. Is repackaging of TEM/TEO Rectoscope, Optical considered manufacturing?

  • Yes, as per the Drugs and Cosmetics Act's definition, repackaging of medical devices is considered as manufacturing, thus requiring a license based on its risk class. For the TEM/TEO Rectoscope, Optical, an MD5 license would be necessary.

Conclusion

Navigating the regulations surrounding medical device manufacturing can be a complex process. Pharmadocx Consultants are well-versed in this area and offer consultation and assistance regarding the licensing process. Please do not hesitate to visit their website here, call them on "+91-7404557227" or email them at "[email protected]". Remember, operating within regulations bolsters the healthcare industry, protecting consumers and patients from substandard products.

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