CDSCO Manufacturing License for Motorized laparoscopic forceps

Introduction

The Central Drugs Standards Control Organization (CDSCO) is an integral part of the healthcare sector in India. Under the Ministry of Health and Family Welfare, the CDSCO handles the regulation and the manufacturing licenses for drugs and medical devices, ensuring the safe and effective production for the market.

Manufacturing licenses have primacy in the medical device industry as they ensure that all produced devices meet international standards for health and safety. Only with a license, the entrant is deemed fit to manufacture, making sure all products are safe for use and effective in their functionality.

One such medical device, playing a critical role in the realm of gastroenterology, is the Motorized laparoscopic forceps. Able to grasp, mobilize, and suture tissues during surgical procedures, these forceps are indispensable in aiding medical professionals during operations.

More about this, including its licensing and manufacturing, can be found on CDSCO's portal here

• What is Motorized laparoscopic forceps?
• The Role of CDSCO in Medical Device Regulation
• How to manufacture Motorized laparoscopic forceps
• Fees for manufacturing license for Motorized laparoscopic forceps
• Why is a Manufacturing License Necessary for Motorized laparoscopic forceps?
• Steps to Obtain a CDSCO Manufacturing License for Motorized laparoscopic forceps
• Frequently Asked Questions (FAQs)
• Conclusion

What is Motorized laparoscopic forceps?

Motorized laparoscopic forceps are AC-powered surgical instruments. These surgical devices are engineered to grasp, mobilize, and suture tissues or vessels during surgical procedures. These procedures are conducted under direct or endoscopic visualization, which confirms the precision and control required while using them.

These specialized tools are commonly used in various procedures involving Gastroenterology due to their precision and minimally invasive nature, making them invaluable assets in the medical world.

The Role of CDSCO in Medical Device Regulation

The CDSCO, since its establishment, has been the pioneer in safeguarding public health in India. Their primary mission revolves around guaranteeing the safety, efficacy, and quality of drugs, cosmetics, and medical devices.

Their regulations and monitoring specialize in normalizing the manufacturing standards of medical devices such as the Motorized laparoscopic forceps. The device falls under risk class B which enables CDSCO to ensure the device's quality adhering to high safety standards.

How to manufacture Motorized laparoscopic forceps

To manufacture any medical device, there are certain prerequisites and documentation that should be in place. After that, there are clearly defined steps that will lead you to the efficient manufacture of your medical device.

Fees for manufacturing license for Motorized laparoscopic forceps

The Motorized laparoscopic forceps being a Class B medical device, require an MD5 license. The fee for the MD5 license is Rs. 5,000 and an additional Rs. 500 fee per product.

Why is a Manufacturing License Necessary for Motorized laparoscopic forceps?

Acquiring a manufacturing license for devices like Motorized laparoscopic forceps is not just mandatory but also integral to quality and safety measures. Regulatory compliance brings credibility to manufacturers and their products.

This also protects consumers and patients from questionable or substandard products, ensuring that every product on the market is safe for use and achieves its purpose without any undesirable side effects.

Steps to Obtain a CDSCO Manufacturing License for Motorized laparoscopic forceps

Getting a manufacturing license involves meticulous work and patient navigation:

1. Documentation: This involves the product’s Device Master File, Quality Management Certificate, Device Details, Site details, and more.
2. Application: After the documents are ready, you will submit your application here
3. Evaluation: The submitted application will be evaluated
4. Approval: After approval, the license will be granted for your product's manufacture

Facing any obstacles? Here is an article that provides solutions that might help you overcome common problems faced during the process.

Frequently Asked Questions (FAQs)

1. Q: What is the risk class of Motorized laparoscopic forceps as per Medical Device Rules, 2017?

   A: The risk class for Motorized laparoscopic forceps is Class B.

2. Q: What license is needed to manufacture Motorized laparoscopic forceps?

   A: To manufacture Motorized laparoscopic forceps, an MD5 license is required.

3. Q: What is the fee for an MD5 license for Motorized laparoscopic forceps?

   A: The fee for an MD5 license is Rs. 5,000 and there is an additional Rs. 500 charge per product.

4. Q: Who will issue the manufacturing license for Motorized laparoscopic forceps?

   A: For Class B devices like Motorized laparoscopic forceps, the State FDA will issue the license.

5. Q: Is repackaging of Motorized laparoscopic forceps considered manufacturing?

   A: Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by extension, medical devices are also drugs. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of Motorized laparoscopic forceps is also considered manufacturing requiring an MD5 license.

Conclusion

Seeking assistance during the licensing process aids in ease and efficiency, ensuring the correct execution of all steps. Consult Pharmadocx consultants for expert assistance or call on "+91-7404557227" or you can even reach out via email at "[email protected]". We are here to help you at every step of the way to make your manufacturing journey smooth and successful.