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CDSCO Manufacturing License for Hemostatic knife

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Introduction

The Central Drugs Standard Control Organization, short for CDSCO, serves a pivotal role in ensuring public health and safety in India. Through the rigorous regulation and surveillance of drugs, cosmetics, and medical devices, the CDSCO guarantees the optimal safe and effective use of these essential health commodities for the citizens.

In the medical device industry, obtaining a manufacturing license is of immense importance. Given the nuances associated with each medical device's inherent uniqueness, the risk involved, and quality considerations, the necessity of a license becomes a mandate to ensure the device's safety and efficacy.

Now, let's take a moment to discuss a remarkable medical device known as the Hemostatic knife. This device is a medical advancement that has made a profound impact on surgical procedures, enhancing their efficiency and outcomes.

For more detailed and official information, refer to CDSCO's online portal here

What is a Hemostatic Knife?

A Hemostatic Knife, in essence, is a surgical severing instrument. Comparable to a scalpel, the key differentiator lies in its blade designed explicitly to be heated by an electric current. This thermal energy transmitted from the blade directly to the body tissues aids in achieving hemostasis, that is, to curb bleeding, making it an invaluable tool in surgeries.

It finds common uses where surgical procedures demand incisions, and the control of bleeding is of highest priority; these include dermatological and plastic surgeries, emergency wound care, etc.

The Role of CDSCO in Medical Device Regulation

The CDSCO, founded under the directive of the Ministry of Health & Family Welfare, Government of India, has been instrumental in championing the cause of health and safety regulation. The cornerstone of the mission is ensuring that all drugs, cosmetics, and medical devices adhere to the stipulated safety and efficacy guidelines before they are made accessible to the public.

When it comes to medical devices, the CDSCO has a comprehensive regulatory framework. It classifies devices into four risk categories: Class A (low risk) to Class D (high risk). Depending on the risk class and the device category, it mandates different licenses for manufacturing these devices.

How to Manufacture a Hemostatic Knife

The manufacturing of a Hemostatic Knife requires precise engineering, adherence to quality management practices and stringent compliance with the regulations laid down by CDSCO. Good Manufacturing Practices (GMP) must be maintained throughout the process to ensure the safety and efficacy of the knife.

Fees for the Manufacturing License for Hemostatic Knife

As a Class B medical device, a Hemostatic Knife requires an MD5 license. The fee for the MD5 license is Rs. 5,000, while an additional fee of Rs. 500 is charged per product.

Why is a Manufacturing License Necessary for Hemostatic Knife?

A manufacturing license is absolutely mandatory for producing any Class B medical device, including a Hemostatic Knife. This is to ensure that the production of these devices is stringently monitored, adheres to quality controls, and fulfills safety protocols. This, in turn, ensures that all citizens have access to standardized, safe, and efficient medical devices.

Regulatory compliance in the healthcare sector plays a crucial role in conferring credibility to the manufacturer, fostering trust in the consumer base, and protecting patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Hemostatic Knife

  1. Preparation of requisite documents such as Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submission of applications along with necessary paperwork.
  3. Addressing queries and documentation gaps, if any.
  4. Await the final approval from CDSCO regarding the manufacturing license.

Successful license procurement might seem challenging but is straightforward if you know how to handle any roadblocks that may come your way.

Frequently Asked Questions (FAQs)

  • Q1: What is the risk class of Hemostatic Knife as per Medical Device Rules, 2017?

  • A1: The Hemostatic Knife falls under risk class B as per Medical Device Rules, 2017.

  • Q2: What license is needed to manufacture Hemostatic Knife?

  • A2: To manufacture Hemostatic Knife, an MD5 license is required.

  • Q3: What is the fee for the MD5 license for Hemostatic Knife?

  • A3: The fee for the MD5 license required to manufacture Hemostatic Knife is Rs. 5,000 for the license, and an additional Rs. 500 per product.

  • Q4: Who will issue the manufacturing license for Hemostatic Knife?

  • A4: For Class B devices like the Hemostatic Knife, the state FDA will issue the license.

  • Q5: Is repackaging of Hemostatic Knife considered manufacturing?

  • A5: Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. So, repackaging of Hemostatic Knife is also viewed as manufacturing, requiring an MD5 license. Here is a complete guide MD5 License.

This information is provided to guide you towards knowing more about the licensing of medical devices.

Conclusion

Navigating the complexities of CDSCO regulations, licenses, and risk classes can be challenging. Pharmadocx consultants are here to make the process seamless and efficient. With deep expertise in the medical device industry, our professionals offer comprehensive support for manufacturers.

For consultation or assistance related to CDSCO manufacturing license and more, visit PharmaDocx here, call us at +91-7404557227, or email us at [email protected]. We specialize in the licensing process and are committed to ensuring the safe and authorized manufacturing of medical devices in India.

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