Indian X-ray Machine Market: Regulations for X-ray Machine

Written by Sudhriti M

21 May 2024

In India, the increasing awareness of benefits of preventive healthcare and early diagnosis is fuelling the demand for medical devices. Improved understanding of the benefits of diagnostic imaging for early detection is driving the growth of Indian X-ray machine market. India’s ageing population is susceptible to chronic and age-related diseases. X-ray imaging can help detect chronic disorders, fractures, and screen for cancer and cardiovascular diseases. Additionally, it is also used to monitor the progress of the treatment. Given the vital role of X-ray machines in India, they are in high demand. Strict regulations for X-ray machine are in place to ensure high quality medical devices enter the Indian market. In this blog, we will focus on the Indian X-ray machine market and CDSCO registration for X-ray machine.

What are X-ray machines?

X-ray machines are important medical diagnostic and imaging tools. The machine emits a controlled and focused beam of X-rays to generate images of the internal structure of human body. The X-ray beam emitted by the machine passes through the body part and is absorbed by the internal structure. The remaining beam is received by the detector. Then, a detailed image of the internal structure is generated by the computer. X-ray machines are vital for timely and accurate diagnosis of chronic orthopaedic disorders, fractures and injuries, cardiovascular diseases, and cancer.

Types of X-ray machines

  • Fixed X-ray machines
  • Mobile X-ray machines
  • Portable X-ray machines

Demand for X-ray machines in India

In India, high prevalence of chronic diseases, such as osteoarthritis, is expected to boost the X-ray machine market. Currently, the X-ray machine market in India is valued at 362.39 million USD. According to market experts, this is expected to grow at a CAGR of 6.34% till the year 2030.

Osteoarthritis is one of the top five chronic disorders in India. By 2025, osteoarthritis may turn into an endemic. Approximately 80% of individuals who are 65 and older would be suffering from joint wear and strain. X-ray machines are used to diagnose and monitor osteoarthritis. Hence, the Indian X-ray machine market growth will be positively impacted by the increasing prevalence of chronic illnesses. However, high equipment costs pose a challenge to the growth of this market. Hence, there is an urgent need for high quality and affordable X-ray machines in India. The government and medical device companies are trying to increase the availability of cost-effective X-ray machines in India.

India also has a high prevalence of fractures and bone injuries caused by accidents and sports-related injuries. X-ray machines are used to diagnose these injuries. In addition to the orthopaedic application of X-ray machines, they are used to screen for cancer and cardiovascular diseases.

Moreover, with the transition from analog to digital systems and the advent of AI chest X-ray applications, diagnosis has become fast and safe. These factors have positively impacted the market size of X-ray machines in India.

Factors fueling the demand for X-ray machines in India

  • Increased diagnostic services: The entire spectrum of the healthcare sector from large hospitals to small clinics is aiming to offer diagnostic imaging services. The goal is to improve the accessibility and availability of X-ray machines in India. Hence, there is an increased demand for X-ray machines.
  • Improvement in imaging technologies: The shift from analog to digital systems significantly improved the X-ray imaging technology. Image capture, image quality, and modification of images have become fast and efficient. The improvement in technology has led to lower exposure to radiations. Additionally, the integration of AI into X-ray imaging technology has considerably improved imaging and diagnosis.
  • Increase in awareness: X-ray machines play a vital role in early detection and monitoring of diseases. In India, increasing number of people are opting for routine screening for early detection of health issues. Awareness of the importance of X-ray machines in diagnosis, monitoring, and screening has fostered the growth of the Indian X-ray machine market.

Indian regulations for X-ray machine

With the high demand for X-ray machines in India, the Indian government has chalked out stringent regulations for X-ray machines. X-ray machines are used to diagnose and monitor various medical conditions. Hence, efficacy of the machines is pivotal. Indian regulations for X-ray machine under the purview of Medical Devices Rules, 2017, demand mandatory CDSCO registration for this medical device. CDSCO registration for X-ray machines will ensure patients in India have access to high quality and effective machines.

Owing to the high unmet need for X-ray machines in India, companies focussing on this segment will have a bright future. Medical device companies will try to tap into the potential of the Indian X-ray machine market. However, substandard and poor-quality machines will hamper the diagnosis, thereby negatively impact patient outcome. CDSCO is the apex regulatory body for all medical devices and has laid down the regulations for X-ray machines. Regulations for X-ray machines ensure medical device companies do not sell substandard medical devices.

CDSCO regulations for X-ray machine

CDSCO regulations for X-ray machine ensure the quality, efficacy, and safety of the device are maintained. CDSCO registration for X-ray machine is aimed at effective healthcare delivery and improved patient care. The regulations for X-ray machine protect the public health. To market your product in India, you will need a CDSCO registration.

CDSCO class and registration process for X-ray machine

To fast track the CDSCO registration process, the regulatory body has categorised medical devices into four classes. Class A, B, C, and D are the four CDSCO medical device classes. As per CDSCO guidelines, X-ray machines have a medium to high level of risk. Hence, depending on the risk level and intended use, CDSCO has classified the X-ray machines as Class C. The registration process will be per the guidelines and requirements for CDSCO Class C medical devices.

Necessary supporting documents for securing CDSCO registration for X-ray machine

  • Cover letter
  • Application form
  • Details and address proof of the applicant
  • Power of attorney
  • Undertaking demonstrating only authentic details have been provided
  • TR6 challan
  • Quality assurance certificate
  • ISO 13485 certificate
  • CE design certificate
  • Plant master file
  • Device master file
  • Free sale certificate

The above list provides a basic outline of the documents required, per CDSCO regulations for X-ray machine. The Pharmadocx Consultants team is ready to help you with a detailed list of documents required for CDSCO registration for X-ray machine.

Benefits of the CDSCO registration for X-ray machine

As a vital machine for diagnosis, monitoring, and screening, this device directly impacts patients’ lives. With the current scenario and predicted potential for growth, medical device companies will aim to focus on this product. The following are the benefits of CDSCO registration for X-ray machines:

  • Assurance of quality and safety: The CDSCO registration assures healthcare professionals and patients that the medical device meets the standard quality and safety benchmark.
  • Brand reputation: Companies selling CDSCO registered medical devices demonstrates their commitment to delivering high quality and safe products. As the medical devices being sold meet rigorous requirements and criteria, this improves the brand’s reputation and credibility. 
  • Indian market access: India is being recognised as a potential global hub for medical devices. A CDSCO registration will give your company access to the Indian medical device market.

Pharmadocx Consultants can make your CDSCO registration for X-ray machines a breeze

To enter the Indian X-ray machine market, you need to understand the CDSCO regulations for X-ray machines in India. The regulations can be difficult to comprehend. The CDCSO registration process can be tricky from choosing the correct form, filling the form correctly to preparing the necessary documents. Pharmadocx Consultants can make the process hassle free. Please don’t hesitate to contact us over [email protected] or 9996859227.

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