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CDSCO Manufacturing License for Partially-implantable abdominal port/catheter

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a critical role in the Indian healthcare sector, responsible for approving new medicines and vaccines, setting standards for pharmaceuticals, and regulating the manufacturing, sale, and distribution of drugs. In the field of medical devices, CDSCO has an extremely vital part to play. The organization plays a significant role when it comes to the manufacturing, import, and distribution of medical devices in India.

The position of manufacturing licenses, especially in the medical device industry, is of utmost importance as it ensures lawfulness, safety, and high-quality standards. One such noteworthy medical device that requires obtaining a license for manufacturing is the "partially-implantable abdominal port/catheter."

To understand how to get a CDSCO manufacturing license, you can visit CDSCO's portal here.

What is a Partially-implantable Abdominal Port/Catheter?

A "Partially-implantable abdominal port/catheter" is a vital medical device, fathomless in purpose and functionality. The device caters for infusion into the peritoneal cavity, delivering essential medications such as insulin or chemotherapeutic agents. Some common procedures involving the use of this medical device are insulin therapy and chemotherapy.

The Role of CDSCO in Medical Device Regulation

The CDSCO, with its mission of safeguarding and enhancing public health in India, is actively involved in ensuring the safety and efficacy of medical devices. The regulatory oversight of CDSCO extends to a broad spectrum of medical devices, including those dealing with the infusion of insulin or chemotherapeutic drugs such as partially-implantable abdominal port/catheter.

How to Manufacture a Partially-implantable Abdominal Port/Catheter

The manufacturing process for this device, like others, requires strict adherence to CDSCO guidelines, expert technical skills, and adequate infrastructure. It is important to ensure that proper sterilization methods, quality controls, and onsite inspections are conducted regularly to ensure utmost safety and efficiency.

Fees for Manufacturing License for a Partially-Implantable Abdominal Port/Catheter

Being a Class C device, the license needed to manufacture a partially-implantable abdominal port/catheter is MD9. The fees for obtaining an MD9 license includes Rs 50,000 for the license and Rs 1,000 per product.

Why is a Manufacturing License Necessary for a Partially-Implantable Abdominal Port/Catheter?

Manufacturing licenses are indispensable in the medical device production landscape. They not only ensure compliance with state regulatory frameworks but also maintain product quality and safety. Licenses are necessary to protect patients and consumers from substandard and unsafe products, further emphasizing the significance of regulatory compliance.

Steps to Obtain a CDSCO Manufacturing License for a Partially-Implantable Abdominal Port/Catheter

The process requires meticulous preparation including:

  1. Assembling necessary documentation like Device Master File, Quality Management Certificate, Device Details, and Site details.
  2. Submission of the application to CDSCO.
  3. Navigating through the approval process.
  4. Overcoming common challenges in the application process.

To learn more about obtaining the MD9 license, visit this link

Frequently Asked Questions (FAQs)

Q1. What is the risk class of a Partially-Implantable Abdominal Port/Catheter as per Medical Device Rules, 2017?

The risk class of a Partially-Implantable Abdominal Port/Catheter is Class C.

Q2. What license is needed to manufacture a Partially-Implantable Abdominal Port/Catheter?

The license needed to manufacture a Partially-Implantable Abdominal Port/Catheter is MD9.

Q3. What are the fees for an MD9 license for a Partially-Implantable Abdominal Port/Catheter?

For an MD9 license for a Partially-Implantable Abdominal Port/Catheter, the fees include Rs 50,000 for the license and Rs 1,000 per product.

Q4. Who will issue the manufacturing license for Partially-Implantable Abdominal Port/Catheter?

The manufacturing license for Class C and D devices will be issued by CDSCO HQ in New Delhi.

Q5. Is repackaging of Partially-Implantable Abdominal Port/Catheter 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 Partially-Implantable Abdominal Port/Catheter is also considered manufacturing requiring an MD9 license.

Conclusion

The process of obtaining a manufacturing license for medical devices from CDSCO can be complex. Nevertheless, it is a journey worth embarking on, given the vital role these devices play in enhancing patient care and medical procedures. To navigate through this process with ease, it's highly recommended to engage professionals who have strong domain knowledge.

For specialized consultation or assistance with the licensing process, reach out to Pharmadocx Consultants via their website, call "+91-7404557227", or email your queries to "[email protected]". Their team will be more than happy to guide and assist you with the entire procedure.

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