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CDSCO Manufacturing License for Bare-metal intracranial vascular stent

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a significant role in India's healthcare sector. As the apex national regulatory body, the CDSCO oversees the quality of drugs, cosmetics, diagnostics, and devices in the country. Under the ambit of the Ministry of Health and Family Welfare, Government of India, CDSCO regulates the manufacture, import, circulation, and sale of these categories of products to ensure their safety, efficacy, and quality.

In the realm of medical devices, the importance of manufacturing licenses cannot be overstated. Such licenses ensure the highest standard of quality and safety, protecting consumers from substandard products. This not only builds trust in the healthcare system but also fosters innovation and growth in the medical industry.

In today's discussion, we are exploring the manufacturing and regulation of a specific, highly advanced medical device - the Bare-metal Intracranial Vascular Stent. As the name suggests, these stents are used for endovascular treatment of intracranial aneurysms, playing a crucial role in neurology and neurosurgery.

For further details related to CDSCO's functions, responsibilities, and online services, you may visit the official website here.

What is a Bare-metal Intracranial Vascular Stent?

A bare-metal intracranial vascular stent is a tubular device implanted into the base or parent artery of an intracranial aneurysm. It acts as a scaffold to support the arterial wall, preserving normal blood flow and preventing the rupture of the aneurysm.

Common procedures involving this medical device include treatment of wide-necked or fusiform aneurysms where conventional endovascular techniques may be challenging. The utilization of these stents is a significant breakthrough, especially when treating complex aneurysms.

The Role of CDSCO in Medical Device Regulation

Throughout history, CDSCO has been the backbone for healthcare safety in India. Its mission centers around safeguarding and enhancing public health by ensuring the quality of drugs and medical devices.

For medical devices, the CDSCO has devised a robust regulatory framework. Outlined in the Medical Device Rules, 2017, it categorizes devices into four classes (A,B,C,D) based on risk. Class A represents the lowest risk, Class B is low to moderate risk, Class C is moderate to high risk, and Class D represents the highest risk.

How to Manufacture a Bare-metal Intracranial Vascular Stent

The manufacturing process for these stents is meticulous and requires a quality management system in place. A comprehensive master file should contain complete details of the device, the manufacturing process, and site details. Licensed manufacturers must demonstrate a high level of quality control to ensure the efficacy and safety of these products.

Fees for Manufacturing License for a Bare-metal Intracranial Vascular Stent

Given the high risk Class D categorization for a bare-metal intracranial vascular stent, the license required is MD9. The licensing fees are INR 50,000, plus an additional INR 1,000 per product. To understand more about the MD9 license, you can visit__here.

Why is a Manufacturing License Necessary for a Bare-metal Intracranial Vascular Stent?

Manufacturing licenses are mandatory and a significant indicator of regulatory compliance in the healthcare sector. They ensure quality and safety in medical device production, and also protect consumers and patients from substandard products. In the case of a bare-metal intracranial vascular stent, the stakes are even higher due to its complex nature and critical role.

Steps to Obtain a CDSCO Manufacturing License for a Bare-metal Intracranial Vascular Stent

  1. Prepare a comprehensive Device Master File.
  2. Obtain a Quality Management Certification.
  3. Submit application with complete device and site details.
  4. Overcome common challenges and await approval.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Bare-metal Intracranial Vascular Stent as per Medical Device Rules, 2017?

  • The risk class for Bare-metal Intracranial Vascular Stent is Class D.

Q2. What license is needed to manufacture a Bare-metal Intracranial Vascular Stent?

  • The MD9 manufacturing license is required.

Q3. What are the fees for an MD9 license for a Bare-metal Intracranial Vascular Stent?

  • The fees are INR 50,000 for the license and an additional INR 1,000 per product.

Q4. Who will issue the manufacturing license for a Bare-metal Intracranial Vascular Stent?

  • The CDSCO headquarters in New Delhi will issue the license as it belongs to Class D risk class category.

Q5. Is repackaging of Bare-metal Intracranial Vascular Stent considered manufacturing?

  • Yes. As per the Drugs and Cosmetics Act's definition, repackaging of drugs is considered manufacturing. Medical devices are also classified as drugs, hence repackaging of a Bare-metal Intracranial Vascular Stent is also considered manufacturing that would require an MD9 license.

Conclusion

Acquiring a manufacturing license for medical devices is a complex procedure that requires in-depth understanding of the regulatory requirements. It's therefore advisable to approach an experienced consultant to navigate the licensing process.

We at Pharmadocx Consultants are here to assist you. With our expertise in CDSCO regulations, we can guide you through every step of the process – from choosing the correct class of medical device, preparing the necessary documents, complying with licensing fees to finally obtaining your manufacturing license.

Reach us out through our website or dial us at +91-7404557227. You can also directly write to us at [email protected] for any additional queries. Our team is eager to support you in your journey.

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