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CDSCO Manufacturing License for Implantable ligating clip

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Introduction

The Central Drugs Standard Control Organization, or CDSCO, serves as the apex national regulatory body for Indian pharmaceuticals and medical devices. Its primary function is to ensure the safety, efficacy, and quality of drugs, cosmetics, diagnostics, and devices, to protect and improve the health system of the country. In the fast-growing medical device industry, gaining a manufacturing license is of paramount importance to ensure the devices produced meet all required standards and regulations, thereby protecting patient health and safety.

Among these regulated medical devices is the Implantable Ligating Clip, a crucial tool used in various surgical procedures. This blog post aims to provide a comprehensive guide on obtaining a CDSCO manufacturing license for the Implantable Ligating Clip. To learn more about the specific regulations, users can access the CDSCO's portal at CDSCO.

What is an Implantable Ligating Clip?

An Implantable Ligating Clip is a surgical device used to connect internal tissues to promote healing. As the name suggests, the clip is implantable, meaning it remains within the patient's body post-surgery. However, unlike other implantable devices, this clip is not absorbable by the body.

These clips are heavily utilized in various surgical procedures, notably in cardiovascular and digestive surgeries, to control blood flow and clamp off vessels or ducts. They are generally made of materials like titanium or polymer to prevent corrosive reactions in the body.

The Role of CDSCO in Medical Device Regulation

Forming an integral part of India's Directorate General of Health Services, CDSCO is responsible for formulating standards and regulatory measures for drugs, cosmetics, diagnostics, and devices in India. CDSCO's mission is to safeguard and enhance public health by ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices.

Regarding medical devices, CDSCO provides the necessary framework for the production and distribution of these devices. It sets the guidelines and standards for each class of devices, which manufacturers must adhere to get their manufacturing licenses.

How to manufacture an Implantable Ligating Clip

The manufacturing of an Implantable Ligating Clip involves a sophisticated and sterile production process which ensures the safety, efficacy, and quality of the final product. Detailed manufacturing procedures are beyond the scope of this blog post. However, it's critical to note that obtaining the necessary manufacturing license is essential and it's subject to approval from regulatory bodies like CDSCO, following stringent evaluation during each step of the manufacturing process.

Fees for manufacturing license for an Implantable Ligating Clip

Since an Implantable Ligating Clip falls under the risk category C, the license required for manufacturing this device is MD9. The fee for an MD9 license is Rs. 50,000 and there's an additional fee of Rs. 1,000 for each product. For more information on MD9 license, check out this informative article at Pharmadocx.

Why is a Manufacturing License Necessary for an Implantable Ligating Clip?

Obtaining a manufacturing license is mandatory to ensure that the devices produced are of high quality and safe to use. This license is especially crucial for medical devices as they are used in critical situations where faulty devices can lead to severe health implications.

Regulatory compliance plays a significant role in maintaining the credibility of the healthcare sector. It not only helps to instill trust among consumers but also safeguards the health of the patients. A manufacturing license assures the consumers and healthcare professionals that the product they are using has met the required safety and quality norms.

Steps to Obtain a CDSCO Manufacturing License for an Implantable Ligating Clip

  1. Compilation of required documents such as Device Master File, Quality Management Certificate, Device Details, Site details among others.
  2. Submission of a properly filled application to the respective authority
  3. Rigorous evaluation process by CDSCO or FDA as per the risk category of the device
  4. Upon successful evaluation, the manufacturing license is granted by the authority

Frequently Asked Questions (FAQs)

Q1. What is the risk class of the Implantable Ligating Clip as per Medical Device Rules, 2017?
A1. Implantable Ligating Clip falls under the risk class C.

Q2. What license is needed to manufacture the Implantable Ligating Clip?
A2. To manufacture Implantable Ligating Clip, manufacturers require an MD9 license.

Q3. What are the fees for MD9 license for Implantable Ligating Clip?
A3. The charges for an MD9 license are Rs. 50,000 for the license and an additional Rs. 1,000 per product.

Q4. Who issues the manufacturing license for an Implantable Ligating Clip?
A4. For Class C devices like Implantable Ligating Clip, the license is issued by the CDSCO Headquarters in New Delhi.

Q5. Is repackaging of Implantable Ligating Clip considered manufacturing?
A5. Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered as manufacturing. As medical devices are also referred to as drugs within the scope of this Act, repackaging of Implantable Ligating Clip also requires a manufacturing license on MD9.

Conclusion

Navigating the licensing process can be a challenging endeavor. If you need expert guidance or consultation regarding the licensing process, there's help available. Reach out to Pharmadocx Consultants via their website, or call them at +91-7404557227, or send an email to [email protected]. Their team of experts is well equipped to help you efficiently navigate the process to attain your manufacturing license.

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