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CDSCO Manufacturing License for Musculoskeletal intense therapeutic ultrasound system

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Introduction

In the healthcare industry, manufacturing licenses are crucial. They validate the safety, efficacy, and quality of the medical devices being produced. The Central Drugs Standard Control Organization (CDSCO) plays an essential role in monitoring these licenses by setting its standards. The CDSCO, under the Ministry of Health & Family Welfare, is in charge of approving medical devices in India.

Their focus is to monitor and meet the needs of the population's healthcare by ensuring the quality, safety and efficacy of drugs and medical devices. They conduct these regulatory functions by assigning a standard control with safety measures that need to be complied with for the licensing, approval, and testing of drugs and medical devices.

One such important medical device is the Musculoskeletal intense therapeutic ultrasound system. The system has significant implications in the rehabilitation medical category and plays an essential role in healthcare. More details on the CDSCO's operations and licensing process can be found on their official portal here.

What is a Musculoskeletal intense therapeutic ultrasound system?

The Musculoskeletal intense therapeutic ultrasound system, as the name suggests, is an intense therapeutic ultrasound device (ITU). ITU's primary objective is to produce and deliver intense ultrasound waves through the skin to create ablative lesions in subcutaneous soft tissues such as muscles and tendons.

Common procedures involving this medical device mainly revolve around rehabilitation medicine or physiotherapy, where it's used in the treatment and management of musculoskeletal pain and inflammation.

The Role of CDSCO in Medical Device Regulation

The CDSCO prides itself on its rich history, which spans over many decades. Over the years, their principal mission has been to safeguard and enhance public health in India by ensuring the quality, safety, effectiveness and access to medical devices that comply with the set standards.

Under their regulatory framework for medical devices, CDSCO ensures adequate and effective control of the import, manufacture, distribution, sale, and use of medical devices in India.

How to manufacture a Musculoskeletal intense therapeutic ultrasound system

The Musculoskeletal intense therapeutic ultrasound system falls under the class C risk category. Therefore, the requisite license for its manufacture is MD9.

Fees for manufacturing license for a Musculoskeletal intense therapeutic ultrasound system

To manufacture a Musculoskeletal intense therapeutic ultrasound system, a fee of Rs. 50,000 is required for the MD9 license. In addition to this, there is a charge of Rs. 1,000 per product. For more details on MD9 license, check this article.

Why is a Manufacturing License Necessary for Musculoskeletal intense therapeutic ultrasound system?

Obtaining a manufacturing license is not an option but a mandatory requirement. It is a crucial step that ensures quality, safety, and consistency in medical device production.

Regulatory compliance in the healthcare sector is of utmost importance. It protects consumers and patients from unsafe and substandard products, ensuring that only quality-tested and approved devices are offered for sale.

Steps to Obtain a CDSCO Manufacturing License for a Musculoskeletal intense therapeutic ultrasound system

Applying for a manufacturing license involves several pre-requisites, such as preparing a Device Master File, obtaining a Quality Management Certificate, detailing the device and site details, and more.

The application process involves four significant steps: submission of the application form, inspection of the manufacturing site, assessment of technical documentation, and approval of the license.

Though the process may seem daunting, following the right guidelines, staying updated with the latest regulations, and seeking professional help can help overcome potential challenges.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of a Musculoskeletal intense therapeutic ultrasound system as per Medical Device Rules, 2017?

  • The Musculoskeletal intense therapeutic ultrasound system falls under the class C risk category.

Q2. What license is needed to manufacture a Musculoskeletal intense therapeutic ultrasound system?

  • The requisite license for manufacturing a Musculoskeletal intense therapeutic ultrasound system is MD9.

Q3. What is the fee for an MD9 license for a Musculoskeletal intense therapeutic ultrasound system?

  • The licensing fee for the MD9 license for a Musculoskeletal intense therapeutic ultrasound system is Rs. 50,000, with an additional charge of Rs. 1,000 per product.

Q4. Who will issue the manufacturing license for a Musculoskeletal intense therapeutic ultrasound system?

  • The CDSCO HQ in New Delhi will issue the class C & D device manufacturing license.

Q5. Is repackaging of a Musculoskeletal intense therapeutic ultrasound system considered manufacturing?

  • Yes, according to the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. By further definitions, medical devices are also drugs. The Medical Device Rules have been made under the provisions of Drug Act, so repackaging of a Musculoskeletal intense therapeutic ultrasound system also requires a license on MD9.

Conclusion

The licensing process for medical devices can be quite tedious and overwhelming. Expert guidance can greatly ease the journey. With that said, feel free to reach out to Pharmadocx Consultants for consultation or assistance regarding the licensing process.

You can visit their website here, call at "+91-7404557227" or send an email to "[email protected]". Their professionals are always ready to lend a helping hand, streamlining the process for you.

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