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CDSCO Manufacturing License for Patient care reverse isolation chamber.

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is an imperative organization in India that works to ensure the quality and safety of drugs, cosmetics and medical devices available to the population. With its main functions revolving around approving licenses for new medicines or medical devices, conducting clinical trials, and ensuring standardization in the medical industry, CDSCO plays a significant role in protecting consumer and patient rights.

In the realm of the burgeoning medical device industry, acquiring a manufacturing license becomes an essential step. This step ensures compliance with regulations, maintaining standardization and quality, and ultimately safeguards the health and safety of the patients at the receiving end. One such significant device is Patient Care Reverse Isolation Chamber.

A CDSCO Manufacturing License is pivotal for its manufacture and distribution, ensuring that it meets all the necessary standards and regulations before being used for medical purposes. You can find all relevant information and guidelines on the CDSCO's portal here.

What is a Patient Care Reverse Isolation Chamber?

A Patient Care Reverse Isolation Chamber is a specialized medical device created with the sole purpose of protecting a patient that may be particularly vulnerable due to their medical condition. Patients suffering from burns, undergoing immunosuppressive therapy, or those who have a congenital abnormality often lack the usual immune defenses.

This medical device plays a crucial role in the patient's treatment and recovery by creating a 'reverse' isolation environment that shields the patient from potential infections or diseases, enhancing their chance for a quicker and safer recovery. It is commonly used in general hospitals and specialized orthopaedic clinics.

The Role of CDSCO in Medical Device Regulation

CDSCO plays a monumental role in the regulation and control of medical devices in India. The organization was established with a mission to protect and uphold public health in India. CDSCO does this by ensuring that the drugs, cosmetics and medical devices available to the public meet global standards of safety, efficacy and quality.

Their regulatory framework for medical devices involves standardizing and regulating their manufacture, sale, and distribution. It is done by classifying devices under four risk categories, granting appropriate manufacturing licenses, and frequently monitoring the industry for any breaches in regulation.

How to Manufacture a Patient Care Reverse Isolation Chamber

If you wish to manufacture a Patient Care Reverse Isolation Chamber, it is mandatory to obtain a CDSCO Manufacturing License first. This license will ensure the legal manufacture and sale of the device and ensure its adherence to the standards and guidelines set by CDSCO.

The manufacturing process must comply with the prescriptions laid down in the Medical Devices Rules, 2017 and other guidance documents published by CDSCO from time to time.

Fees for manufacturing license for a Patient Care Reverse Isolation Chamber

The Patient Care Reverse Isolation Chamber falls under the risk Class B, and therefore requires the MD5 license for manufacturing. The fee for the MD5 license is Rs. 5,000, and it also includes an additional cost of Rs. 500 per product (in this case, per chamber). For more details, you can refer to this article.

Why is a Manufacturing License Necessary for a Patient Care Reverse Isolation Chamber?

Obtaining a manufacturing license for a Patient Care Reverse Isolation Chamber is not only mandatory but also significant for multiple reasons. It ensures quality and safety in medical device production, adherence to regulatory compliances, and protection for consumers and patients from substandard products that could compromise their health and safety.

Steps to Obtain a CDSCO Manufacturing License for a Patient Care Reverse Isolation Chamber

The process to obtain a CDSCO Manufacturing License for a Patient Care Reverse Isolation Chamber involves few steps along with necessary documentation.

  1. Ensure you have all the essential documents such as the Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submit your application to the state FDA for Class B devices along with the necessary fees and documents.
  3. Await the approval of your application.
  4. Overcome any problems that arise with the help of a sanctioned advisor.

Frequently Asked Questions (FAQs)

  1. Q1. What is the risk class of Patient Care Reverse Isolation Chamber as per Medical Device Rules, 2017? The risk class of Patient Care Reverse Isolation Chamber as per Medical Device Rules, 2017 is Class B.

  2. Q2. What license is needed to manufacture a Patient Care Reverse Isolation Chamber? The MD5 license is needed to manufacture a Patient Care Reverse Isolation Chamber.

  3. Q3. What is the fee for the MD5 license for a Patient Care Reverse Isolation Chamber? The fee for the MD5 license is Rs. 5,000 and an additional cost of Rs. 500 per product, which in this case is per Patient Care Reverse Isolation Chamber.

  4. Q4. Who will issue the manufacturing license for a Patient Care Reverse Isolation Chamber? For Class B devices such as the Patient Care Reverse Isolation Chamber, the state FDA will issue the license.

  5. Q5. Is repackaging of a Patient Care Reverse Isolation Chamber considered manufacturing? Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and, by further definitions, medical devices are also drugs. Therefore, repackaging of a Patient Care Reverse Isolation Chamber is also considered manufacturing, requiring an MD5 license for this.

Conclusion

Obtaining a CDSCO Manufacturing License for a medical device like Patient Care Reverse Isolation Chamber is not only obligatory but also a comprehensive process that involves a series of steps and requires several necessary documents. Having professional guidance can make this process easier and smoother.

We at Pharmadocx Consultants can assist you through every step and help you overcome any challenges that you may encounter. Reach out to us for professional consultation or assistance through our website here or call us on +91-7404557227. You can also send us an email at [email protected] and we’ll be there to support you in no time!

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