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CDSCO Manufacturing License for Respiratory oxygen monitor

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is instrumental in safeguarding public health in India. Being India's national regulatory body for pharmaceuticals and medical devices, CDSCO shoulders monumental responsibilities. It ensures that the medical devices manufactured and circulated in the country adhere to international safety standards.

A crucial part of this regulatory system is the issuance of manufacturing licenses for medical devices. Exclusive permits are required for different risk classes of medical devices to ensure strict quality control. This blog post will focus on the CDSCO manufacturing licenses, specifically pertaining to respiratory oxygen monitors— Class B medical devices widely used in the healthcare sector. For detailed regulatory information, you can visit the CDSCO's official portal at CDSCO

What is a Respiratory Oxygen Monitor?

A respiratory oxygen monitor is a medical device intended to measure the concentration levels of oxygen a patient inhales during respiratory therapy. It plays a pivotal role in monitoring and regulating oxygen supplied to patients in critical health conditions and those undergoing anesthesia.

Commonly, respiratory oxygen monitors are used in hospital settings, particularly in intensive care units, operating rooms, and during anesthesia procedures. It's an integral part of the medical infrastructure that aids healthcare providers to deliver precise and effective respiratory support to the patients.

The Role of CDSCO in Medical Device Regulation

The CDSCO was established with the mission to reform and enhance public health through stringent regulation and supervision of the safety, efficacy, and quality of drugs, cosmetics, and medical devices. It's CDSCO's responsibility to regulate the manufacturing, import, distribution, and sale of these items.

An essential part of this regulatory framework constitutes controlling and supervising the production of medical devices. Depending upon the risk associated, medical devices are categorized into Classes A, B, C, and D. Each class requires a specific license - Class A and B devices need MD5, while Classes C and D require MD9.

How to manufacture a Respiratory Oxygen Monitor

It is important to remember that manufacturing respiratory oxygen monitors necessitates an MD5 license because it falls under the Class B medical device category. Obtaining the appropriate manufacturing license is the first step towards producing these vital devices.

Fees for a Manufacturing License for a Respiratory Oxygen Monitor

For Class B devices like a respiratory oxygen monitor, the license fee would be INR 5000 with an additional INR 500 per product.

Why is a Manufacturing License Necessary for a Respiratory Oxygen Monitor?

Obtaining a manufacturing license is not only a regulatory but also a mandatory requirement. The process of approval ensures that the devices manufactured meet the prescribed quality and safety standards.

In the healthcare sector, regulatory compliance is critical. It protects consumers and patients from substandard and unsafe medical devices like respiratory oxygen monitors. Hence, obtaining a manufacturing license affirms the quality, safety, and efficacy of these products.

Steps to Obtain a CDSCO Manufacturing License for a Respiratory Oxygen Monitor

The process involves document submission, including Device Master File, Quality Management Certificate, Device Details, Site details, among others. Upon successful verification and ultimate approval, the state FDA issues the license for manufacturing the respiratory oxygen monitor.

Application Process:

  1. Submission of application and necessary documents
  2. Verification of the application by the concerned authorities
  3. Approval by the responsible authority
  4. Granting of the manufacturing license

Frequently Asked Questions (FAQs)

  1. Q: What is the risk class of the respiratory oxygen monitor as per Medical Device Rules, 2017?
    A: The respiratory oxygen monitor is classed as a Class B device.
  2. Q: What license is needed to manufacture a respiratory oxygen monitor?
    A: MD5 license is needed to manufacture a respiratory oxygen monitor.
  3. Q: What is the fee for the MD5 license for a respiratory oxygen monitor?
    A: It's Rs. 5,000 for the license and Rs. 500 per product.
  4. Q: Who will issue the manufacturing license for a respiratory oxygen monitor?
    A: The state FDA will issue the license
  5. Q: Is repackaging of the respiratory oxygen monitor considered manufacturing?
    A: Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing, and by further definitions, medical devices are also drugs. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of the respiratory oxygen monitor is also considered manufacturing requiring a license on MD5.

Read more about MD5 License here.

Conclusion

Dealing with licensing matters can be quite daunting without the right assistance. At Pharmadocx consultants, we strive to simplify the process for you. If you seek consultation or assistance regarding licensing or any regulatory affairs, please do not hesitate to reach out to us or call us at +91-7404557227 or send us an email to [email protected]. We're here to aid you in every possible way.

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