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CDSCO Manufacturing License for Implanted intracerebral/sub cortical stimulator for pain relief.

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in India's healthcare sector. Every day, thousands of citizens depend on medical devices to support their health, making the CDSCO's role in regulating these devices crucial. By defining safety standards and ensuring that manufacturers adhere to them, they protect the health of the public. This is primarily achieved through the issuance of manufacturing licenses, which are obligatory for any entity manufacturing medical devices in the country.

One such medical device that holds a significant place in the healthcare sector is the Implanted intracerebral/subcortical stimulator for pain relief. Through this critical device, countless individuals achieve pain relief and improved quality of life. If you wish to delve deeper into CDSCO's responsibilities and the significance of licensing, you can visit their dedicated portal HERE

What is an Implanted intracerebral/subcortical stimulator for pain relief?

An Implanted intracerebral/subcortical stimulator for pain relief, as its name suggests, is a medical device that mechanically aids in relieving severe, intractable pain in patients. It achieves this by applying electrical current to subsurface areas of the patient’s brain. The device consists of an implanted receiver with electrodes strategically placed within the brain and an external transmitter responsible for transmitting stimulating pulses across the patient's skin to the implanted receiver.

In the field of neurology, the use of this device has been instrumental in managing pain and improving the well-being of patients dealing with long-term severe and resistant to treatment pain conditions.

The Role of CDSCO in Medical Device Regulation

The CDSCO, from time to time, has been actively involved in ensuring that all medical devices manufactured and deployed in the Indian Healthcare sector align with the necessary safety standards. This regulatory body came into existence with the principal mission to safeguard public health in India by ensuring that the highest standards of safety, efficacy, and quality are met by all medical devices available in the Indian markets.

Following a well-laid and stringent regulatory framework set for medical devices, CDSCO is responsible for granting licenses to manufacturers, allowing them to produce, sell, and distribute medical devices, upholding the interests of consumers, and protecting them from substandard and potentially harmful products.

How to manufacture an Implanted intracerebral/subcortical stimulator for pain relief

Before the production of the Implanted intracerebral/subcortical stimulator for pain relief can begin, a critical requirement is the attainment of the CDSCO manufacturing license. To obtain this, it's necessary to engage CDSCO in the early stages of design and development to ensure compliance with regulatory standards.

Fees for manufacturing license for an Implanted intracerebral/subcortical stimulator for pain relief

There are separate categories of manufacturing license fees according to the risk classification of the medical device. As the Implanted intracerebral/subcortical stimulator for pain relief falls into risk class D, the appropriate license will be MD9. The fee for MD9 is Rs. 50,000 for the license, and additionally, Rs. 1,000 per product.

Why is a Manufacturing License Necessary for an Implanted intracerebral/subcortical stimulator for pain relief?

Acquiring a manufacturing license is non-negotiable. A manufacturing license stands as a testament to the manufacturer's adherence to quality and safety standards in medical device production. Within the healthcare sector, ensuring regulatory compliance is of utmost significance. Securing this approval protects consumers and patients from low-quality or dangerous products, thus ensuring their safety and promoting their trust in the overall healthcare system.

Steps to Obtain a CDSCO Manufacturing License for an Implanted intracerebral/subcortical stimulator for pain relief

  1. Prepare all necessary documentation, such as the Device Master File, Quality Management Certificate, detailed information about the device, and site details, among other things.
  2. Submit your application to the CDSCO, including all the required documents.
  3. Wait for CDSCO to review the application and provide approval
  4. Upon approval, pay the required license fee and start production

Do note that you may encounter other challenges during the application process. To overcome them, it is advisable to engage with professional consultants who can guide you through the complex regulatory framework. If the license required is MD9, like for Class D devices, more information about the procedure can be found HERE

Frequently Asked Questions (FAQs)

Q1: What is the risk class of the Implanted intracerebral/subcortical stimulator for pain relief as per Medical Device Rules, 2017?

The Implanted intracerebral/subcortical stimulator for pain relief falls under risk class D.

Q2: What license is needed to manufacture an Implanted intracerebral/subcortical stimulator for pain relief?

A MD9 license is required to manufacture the Implanted intracerebral/subcortical stimulator for pain relief.

Q3: What is the fee for an MD9 license for an Implanted intracerebral/subcortical stimulator for pain relief?

The fee for an MD9 license is Rs. 50,000 for the license, and Rs. 1,000 per product.

Q4: Who will issue the manufacturing license for an Implanted intracerebral/subcortical stimulator for pain relief?

For Class D devices like the Implanted intracerebral/subcortical stimulator for pain relief, CDSCO HQ in New Delhi will issue the license.

Q5: Is repackaging of an Implanted intracerebral/subcortical stimulator for pain relief considered manufacturing?

Yes, under the definitions laid down by the Drugs and Cosmetics Act, repackaging of drugs is tantamount to manufacturing, and medical devices also fall under this definition. Therefore, the repackaging of an Implanted intracerebral/subcortical stimulator for pain relief also requires a manufacturing license (MD9 in this case).

Conclusion

Understanding CDSCO's regulations and obtaining a manufacturing license can be a challenging endeavor. Expert consultation can often make the difference between a smooth licensing journey and one riddled with obstacles. Do not hesitate to reach out to Pharmadocx Consultants for assistance regarding the licensing process. Visit the official Pharmadocx website HERE, dial +91-7404557227 or send your inquiries to [email protected] at any time.

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