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CDSCO Manufacturing License for Environmental chamber for storage of platelet concentrate

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is the paramount drug regulatory authority in India, responsible for the approval of new drugs, conduct of clinical trials, laying down the standards for drugs, control over the quality of imported drugs, coordination of the activities of State Drug Control Organizations and providing expert advice to bring about uniformity in the enforcement of the Drugs and Cosmetics Act.

Within the medical device industry, acquiring the proper manufacturing licenses is crucial. It ensures the quality of the devices produced and guarantees adherence to the standard regulations put into practice to protect consumers and users.

Today, we take a look at the Environmental Chamber for Storage of Platelet Concentrate. This device plays an important role within the medical industry, especially in our hospitals.

To find out more about CDSCO and its functions, please check out their official portal CDSCO's official portal.

What is Environmental Chamber for Storage of Platelet Concentrate?

The Environmental Chamber for Storage of Platelet Concentrate is a refrigerated storage device used to hold platelet-rich plasma within a preselected temperature range. Its main purpose is to maintain an environment conducive for the storage of platelet concentrate, ensuring their optimum usability in medical procedures.

Common uses of this medical equipment are seen within the health industry particularly, in hospital laboratories and blood banks. Wherever there is a need to store platelets for transfusion, you will find the use of these chambers.

The Role of CDSCO in Medical Device Regulation

CDSCO plays a major role in setting down the standards for medical devices in India. This includes formulating policies and guidelines for medical devices, evaluating their safety and efficacy, and ensuring uniform control over their manufacture, import, transmission, and distribution throughout the country.

How to manufacture Environmental Chamber for Storage of Platelet Concentrate

The manufacturing process of the Environmental Chamber for Storage of Platelet Concentrate involves adherence to stringent regulations laid down by CDSCO. These guidelines ensure the production of high-quality medical devices that meet the standards of safety and efficacy.

Fees for manufacturing license for Environmental Chamber for Storage of Platelet Concentrate

Given that the Environmental Chamber for Storage of Platelet Concentrate falls under risk class B, the required license is MD5. The fees for MD5 license stands at Rs. 5,000 for license and Rs. 500 per product. For more information about the MD5 license, please refer to this article.

Why is a Manufacturing License Necessary for Environmental Chamber for Storage of Platelet Concentrate?

Manufacturing licenses ensure quality control and user safety. Regulatory compliance ensures that the consumers and patients are protected from substandard products. Furthermore, it's obligatory to acquire a manufacturing license before producing any medical device in India.

Steps to Obtain a CDSCO Manufacturing License for Environmental Chamber for Storage of Platelet Concentrate

  1. Prepare necessary documents such as the Device Master File, Quality Management Certificate, Device Details, and Site details.
  2. Submit the application to the state FDA for the license.
  3. Await validation and approval from the authority.
  4. Overcome any challenges that may arise, with consultation from a reliable source like Pharmadocx Consultants.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Environmental Chamber for Storage of Platelet Concentrate as per Medical Device Rules, 2017?

A1. The risk class for Environmental Chamber for Storage of Platelet Concentrate is B.

Q2. What license is needed to manufacture Environmental Chamber for Storage of Platelet Concentrate?

A2. To manufacture Environmental Chamber for Storage of Platelet Concentrate, an MD5 license is required.

Q3. What are the fees for an MD5 license for Environmental Chamber for Storage of Platelet Concentrate?

A3. The fees for an MD5 license are Rs. 5,000 for the license and Rs. 500 per product.

Q4. Who will issue the manufacturing license for Environmental Chamber for Storage of Platelet Concentrate?

A4. For class B devices like this one, the state FDA will issue the license.

Q5. Is repackaging of Environmental Chamber for Storage of Platelet Concentrate considered manufacturing?

A5. Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Therefore, repackaging of Environmental Chamber for Storage of Platelet Concentrate is also considered manufacturing requiring an MD5 license.

Conclusion

Information on the CDSCO and the licensing process may become overwhelming especially when considering manufacturing a medical device. Remember, quality and safety measures are imperative in the medical field. Therefore, entrusting your questions and consulting with professionals might just make the whole process easier for you.

Lean on professional consultants at Pharmadocx Consultants for all your queries and assistance needed in obtaining a manufacturing license for your medical device. You could also dial "+91-7404557227" or email to "[email protected]" for immediate and comprehensive help.

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