CDSCO Registration for MRI machine in India

Written by Sudhriti M

21 May 2024

MRI machines play a critical role in enhancing patient care. They help take informed decisions by providing a non-invasive three-dimensional internal view of the human body. In India, awareness regarding the important role ofdiagnostic imaging in early detection is increasing. MRI is one of the vital diagnostic imaging medical devices for early diagnosis of diseases and monitoring treatment progress. Owing to the demand for these machines in India, stringent regulatory guidelines are required. Regulations for MRI machine ensure poor quality substandard machines do not enter the Indian medical device market. CDSCO registration for MRI machine validates quality, safety, and efficacy of the devices being used in the Indian healthcare system. In this blog, we will delve into current Indian MRI machine market and regulatory requirements for MRI machines in India.

MRI in healthcare sector

Magnetic resonance imaging (MRI) is a pivotal component of radiology and diagnostic imaging. It is a non-invasive medical imaging technique used to generate images of the anatomy and physiological processes of the body. The three-dimensional anatomy images generated are used to diagnose and identify any abnormalities in the body. MRI is not only used to detect and diagnose diseases but also to monitor the treatment progress.

MRI uses magnetic field and computer-generated radio waves to generate detailed images of the organs and tissues in the body. The high-resolution images are used by medical professionals to examine the internal organs, tissues, and skeletal system. MRI has played a crucial role in modern medicine by revolutionizing the digital healthcare system.

Indian MRI machine market

Currently, the Indian MRI machine market size is estimated at USD 308.03 million. The market size is projected to grow at a CAGR of 6.11% during 2024–2029. It is expected to be valued at USD 414.35 million by 2029. Installation of advanced MRI machines as a part of development of healthcare infrastructure is the key factor fuelling market expansion.

The Indian MRI machine market can be broken down into the following segments:

  • Architecture: closed and open MRI systems
  • Field strength: low-field, high-field, very high-field, and ultra-high MRI systems
  • Application: oncology, neurology, cardiology, musculoskeletal, gastroenterology, and others

As per analysis of the Indian MRI machine market, very-high field MRI systems and application in oncology field are expected to grow at a significant rate. The very-high field MRI system produces enhanced spatial resolution and picture quality. This makes it useful for Alzheimer’s disease and mild traumatic brain injury diagnosis and monitoring. Additionally, with the increasing prevalence of cancer in India, diagnostic tools for cancer will be in demand. MRI can generate detailed images of internal structures, which can be used to identify and evaluate tumours and other abnormalities. Hence, MRI plays a crucial role in cancer diagnosis and treatment. Owing to its applicability in the oncology field, demand for MRI machine is expected to grow.

The demand for MRI machines in India is increasing steadily. Significant investments are being made to improve the accessibility to this medical device. Moreover, high neurological disorder prevalence in India is driving the demand for early diagnosis using MRI. Indian government has collaborated with major players to facilitate installation of advanced MRI equipment in healthcare facilities across the country. All these factors are augmenting the Indian MRI machine market.

Although the demand for MRI machines in India is high, the market is highly competitive. This is because several major players are currently dominating the Indian MRI machine market. Along with accessibility, affordability is a major obstacle in using this medical imaging technique. Heavy import dependence and high initial setup cost are some of the challenges faced by the Indian MRI machine market. Thus, to cater to the Indian market, companies will have to offer low cost, high quality, and advanced MRI machines. Manufacturing high end MRI machines in India would reduce dependence on import, thus reduce the cost. Mid-size to small companies are trying to increase their market presence by launching low-cost and high-quality MRI machines in India.

CDSCO registration for MRI machine

Central Drugs Standard Control Organisation (CDSCO) is the apex regulatory body for all medical devices marketed in India. CDSCO functions under the purview of Medical Device Rules, 2017, to ensure inferior-quality machines do not enter the Indian market. Substandard machines can lead to inaccurate diagnosis, thereby incorrect treatment and negative patient outcome. The regulatory body is aimed at protecting the public health. CDSCO has stringent regulations for MRI machine marketed in India. CDSCO registration for MRI machine is mandatory to sell your products in India. The registration assures the medical professionals of the quality of the machines they are using. CDSCO regulations for MRI machine monitor its safety, quality, and efficacy.

CDSCO definition and class for MRI machines

CDSCO has defined MRI as a medical imaging procedure that uses radio waves, magnetic fields, and magnetic field gradients. It is used to capture images of the organs in the body.

Depending on the risk level and intended use, CDSCO has classified MRI machines as Class C medical device. Hence, the application process for CDSCO registration for MRI machine will be per the guidelines for Class C medical devices.

License and licensing authority

As per regulations for MRI machine, MD-9 license will be required to manufacture MRI machines in India. MD-10 loan license will be required for those manufacturers without a manufacturing facility. MD-15 license will be required to import MRI machines into India.

For CDSCO registration for MRI machine, the medical device company needs to apply to the Central Licensing Authority (CLA). The CLA grants licenses for all Class C and D medical devices sold in India.

Supporting documents required for CDSCO registration for MRI machine

  • Cover letter
  • Details and address proof of the applicant
  • Power of attorney
  • Manufacturer’s address and details
  • Undertaking proving the authenticity of the details submitted
  • TR6 challan
  • Site details
  • Quality assurance certificate
  • ISO 13485 certificate
  • Free sale certificate
  • Plant master file
  • Device master file
  • CE design certificate

These are some of the documents required for CDSCO registration for MRI machine. The Pharmadocx Consultants team is ready to help you with a detailed list of documents required and prepare them.

Application process for CDSCO registration for MRI machine

  • The applicable application form needs to be submitted on the official CDSCO online registration portal, SUGAM.
  • The essential supporting documents need to be collated per CDSCO regulations for MRI machine and submitted along with the application.
  • Documents demonstrating quality management system requirement compliance need to submitted.
  • The regulatory officials will review the application and verify the documents. If applicable, then the officials will inspect the site.
  • If all the criteria are satisfied, then the regulatory body will grant the applicable license.

Do you want to register your MRI machines in India?

Are you planning to enter the Indian MRI machine market? Are you unclear of the CDSCO regulations for MRI machine? Need guidance and support for CDSCO registration for MRI machine? Well, look no beyond. The Pharmadocx Consultants team is here to help you. Registering medical devices in India is our forte. Let us help you sort out your MRI machine license application. Our expertise in this field will ensure your registration process is free from any hiccups. Drop us an email at [email protected] or call/Whatsapp us at 9996859227 and let us help you.

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