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CDSCO Manufacturing License for Bone sonometer

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a crucial role in ensuring that medical devices produced or sold in India meet the highest standards of safety and effectiveness. Its primary mandate is to regulate the import, manufacture, distribution, and sales of drugs, ensuring quality, safety, and efficacy. But, it's not just limited to drugs, they also oversee the quality of medical devices, making manufacturing licenses a crucial part in the medical device industry.

Today, we will discuss the manufacturing license for a Bone sonometer, a Class B risk device, under CDSCO's regulatory framework. Bone sonometers are instrumental in the field of radiology, offering crucial insights into a person's bone health and potential fracture risks. For more information about CDSCO and its procedures, you can visit their official portal here.

What is a Bone Sonometer?

A Bone Sonometer is a medical device designed to transmit ultrasound energy into the human body. The purpose of this device is to measure the acoustic properties of the bone, which provides valuable information about the overall health of the bone and the potential risk of fractures. They are commonly used in procedures to diagnose conditions related to bone density and bone health.

The Role of CDSCO in Medical Device Regulation

The mission of CDSCO is to safeguard and enhance public health by assuring the safety, efficacy, and quality of drugs and medical devices. CDSCO follows a regulatory framework for medical devices, which categorizes them based on risk differential, ranging from low risk (Class A) to high risk (Class D). The Bone Sonometer, which falls under Class B, needs to follow the protocols and obtain a manufacturing license from the CDSCO.

How to manufacture a Bone Sonometer

Producing a medical device like a Bone Sonometer requires adherence to strict regulations, including obtaining a proper manufacturing license. Further sections will detail the steps required to acquire these licenses.

Fees for manufacturing license for a Bone Sonometer

The manufacturing license fee for devices like Bone Sonometer, which falls under risk Class B, requires a license type MD5. The fee for an MD5 license is Rs. 5,000 with an additional charge of Rs. 500 per product. More information can be found here.

Why is a Manufacturing License Necessary for a Bone Sonometer?

Obtaining a manufacturing license is not just mandatory, it ensures the quality and safety of medical devices. The CDSCO licensing requirement facilitates regulatory compliance in the production process and protects consumers and patients from sub-par products while maintaining the integrity of the healthcare sector.

Steps to Obtain a CDSCO Manufacturing License for a Bone Sonometer

The manufacturing license requires adherence to certain preset rules and protocols:

  • Device Master File, Quality Management Certificate, Device Details, Site details are just some of the prerequisites and documentation required.
  • The application process includes a stepwise procedure from submission of application forms to validation and approval.
  • Certain challenges may be encountered during the process, solutions for which will be discussed later in this blog.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Bone Sonometer as per Medical Device Rules, 2017?
A1. The Bone Sonometer is categorized under risk class B as per Medical Device Rules, 2017.

Q2. What license is needed to manufacture Bone Sonometer?
A2. An MD5 license is required to manufacture a Bone Sonometer.

Q3. What is the fee for an MD5 license for a Bone Sonometer?
A3. The fee for an MD5 license is Rs. 5,000 with an additional charge of Rs. 500 per product.

Q4. Who will issue the manufacturing license for Bone Sonometer?
A4. The state FDA will issue the manufacturing license for Class B devices like Bone Sonometer.

Q5. Is repackaging of Bone Sonometer considered manufacturing?
A5. Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. By extension, repackaging of the Bone Sonometer is also considered manufacturing, requiring an MD5 license.

Conclusion

Regulatory compliance, safety, and quality assurance are paramount in the medical device industry. Understanding these requirements is important in navigating licensing processes smoothly. Should you need consultation or assistance regarding the licensing process for manufacturing medical devices, do not hesitate to reach out to Pharmadocx Consultants by calling +91-7404557227 or by sending an email to [email protected].

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