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CDSCO Manufacturing License for Respiratory oxygen therapy monitor/regulator

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Introduction

The Central Drugs Standard Control Organization, commonly known as CDSCO, acts as the national regulatory authority that oversees the safety, quality and efficacy of medical devices in India. The numerous functions and responsibilities of CDSCO are instrumental in the regulation of drug and medical devices. Throughout its history, CDSCO has been tirelessly working towards the promotion of public health in India by diligently updating rules and regulations according to international standards and adapting to latest advancements in the medical field.

Acquiring a manufacturing license is of paramount importance in the medical device industry. By ensuring that every medical device produced adheres to the regulations defined by the CDSCO, we can ensure the quality and safety of medical devices in the market.

In this blogpost, we will be focusing on Respiratory Oxygen Therapy Monitor/Regulator, which is an essential medical device with significant medical implications. It plays a crucial role in the healthcare industry particularly for patients with respiratory conditions or those needing oxygen therapy. Make sure to visit CDSCO's online portal https://cdscomdonline.gov.in/NewMedDev/Homepage for more details.

What is Respiratory Oxygen Therapy Monitor/Regulator?

A Respiratory oxygen therapy monitor/regulator is an electrically-powered device that is used to deliver oxygen to patients who are spontaneously breathing, but require administration of supplemental oxygen. It not only delivers the oxygen, but also monitors the oxygen saturation levels in the patient's bloodstream and adjusts the oxygen level accordingly. This medical device is commonly used in the pre-hospital and in-hospital settings, particularly in anesthesia.

The Role of CDSCO in Medical Device Regulation

CDSCO, since its inception, has been dedicatedly executing its mission of safeguarding and enhancing the public health in India. It spearheads the regulation of drugs and medical devices thus ensuring their safety, efficacy and quality. The regulatory framework for medical devices is multi-tiered which encompasses standards of manufacturing, import, sale, clinical trials, marketing approval, etc.

How to manufacture Respiratory Oxygen Therapy Monitor/Regulator

Respiratory Oxygen Therapy Monitor/Regulator falls under Class B risk category. Therefore, a manufacturer is required to have a MD5 License for its manufacture.

Fees for manufacturing license for Respiratory Oxygen Therapy Monitor/Regulator

A manufacturer will be required to pay Rs. 5,000 for the MD5 license and additionally, Rs. 500 per product. Detailed information about the same can be found at https://pharmadocx.com/md-5-licesne-class-a-b-medical-devices/.

Why is a Manufacturing License Necessary for Respiratory Oxygen Therapy Monitor/Regulator?

Manufacturing licenses are mandatory as they ensure that the manufactures adhere to the standards and regulations prescribed by the CDSCO. It lends credibility to the manufacturer and reassures the quality and safety of its medical devices. Furthermore, a license also keeps a check on unscrupulous players and protects consumers from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Respiratory Oxygen Therapy Monitor/Regulator

  1. Preparing necessary documents such as Device Master File, Quality Management Certificate, site details, etc.
  2. Submitting the documents to the respective licensing authority.
  3. Waiting for their assessment and approval.
  4. In case of any hindrances or challenges, seeking guidance from seasoned professionals.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Respiratory Oxygen Therapy Monitor/Regulator as per Medical Device Rules, 2017?

Respiratory Oxygen Therapy Monitor/Regulator is a Class B device as per Medical Device Rules, 2017.

Q2. What license is needed to manufacture Respiratory Oxygen Therapy Monitor/Regulator?

An MD5 license is needed to manufacture Respiratory Oxygen Therapy Monitor/Regulator.

Q3. What is the fee for MD5 license for Respiratory Oxygen Therapy Monitor/Regulator?

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

Q4. Who will issue the manufacturing license for Respiratory Oxygen Therapy Monitor/Regulator?

State FDA will issue the license for Class B devices like Respiratory Oxygen Therapy Monitor/Regulator.

Q5. Is repackaging of Respiratory Oxygen Therapy Monitor/Regulator considered manufacturing?

Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of Respiratory Oxygen Therapy Monitor/Regulator is considered manufacturing and requires an MD5 license.

Conclusion

Acquiring a manufacturing license can be a tedious process filled with complexities. Having a consultant or expert by your side can make a significant difference. If you require any consultation or assistance regarding the licensing process, don't hesitate to reach out to Pharmadocx Consultants. You can visit "https://www.pharmadocx.com" or call "+91-7404557227". You can also send an email to "[email protected]". Take advantage of the expert advice and make your journey towards getting a manufacturing license smoother.

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