Owing to high demand for X-ray machines in India, the Indian government has chalked out stringent regulations for them. Central Drugs Standard Control Organisation (CDSCO) is the apex regulatory body for all medical devices. CDSCO regulations for X-ray machines are in place to ensure poor quality and ineffective devices do not enter the market. Moreover, X-ray machines have a vital role in diagnostic imaging. Hence, manufacturers will have to strictly comply with these regulations to launch their products in India. Per CDSCO guidelines, securing the CDSCO license for X-ray machines is a mandatory requirement. Hence, we have prepared this guide to help you have a smooth regulatory journey and easily bring your X-ray machines to the market.
Common types of X-ray machines used in the healthcare industry
X-ray machines have a vital role in the healthcare industry. We have listed some of the common types of X-ray machines used in the healthcare industry.
- Fluoroscopy X-ray machines: X-ray machine used for real-time imaging for procedures, such as angiography.
- Radiography X-ray machine: X-ray machine used for obtaining still images of bones and organs.
- Mammography machine: Specialized X-ray machine for breast cancer detection.
- Dental X-ray machine: X-ray machine used for oral examinations.
- C-arm X-ray machine: Mobile X-ray machine for surgical procedures.
- Computed tomography (CT) scanner: X-ray machine used to create 3D images for detailed diagnostics.
Indian X-ray machine market
In India, the increase in awareness of benefits of preventive healthcare and early diagnosis is fuelling the demand for medical devices. X-ray machine is an important medical diagnostic and imaging tool. Improved understanding of the benefits of diagnostic imaging for early detection is driving the growth of the 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.
X-ray machines are vital for timely and accurate diagnosis of chronic orthopaedic disorders, fractures and injuries, cardiovascular diseases, and cancer. In India, high incidence of chronic diseases, such as osteoarthritis, is expected to boost the X-ray machine market. Moreover, India 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. Furthermore, cancer and cardiovascular diseases are also on the rise fuelling the demand for X-ray machines.
Currently, the Indian X-ray machine market is valued at 362.39 million USD. According to market experts, the market value is expected to grow at a CAGR of 6.34% till the year 2030. Hence, increase in awareness and improvement in X-ray machines is boosting the Indian X-ray machine market. Furthermore, the government is trying to improve accessibility and availability of X-ray machines in India, which is further driving the growth of the market.
CDSCO regulations for X-ray machines in India
As a vital machine for diagnosis, monitoring, and screening, X-ray machines directly impact patients’ lives. With the current scenario and predicted potential for growth, medical device companies will aim to focus on this product. Thus, CDSCO regulations for X-ray machines aim to ensure medical device companies do not sell substandard devices. X-ray machines are used to diagnose and monitor various medical conditions. Hence, efficacy of the machines is pivotal. However, substandard and poor-quality machines will hamper the diagnosis, thereby negatively impact patient outcome. By formulating stringent regulations, CDSCO aims to ensure inferior-quality X-ray machines do not enter the Indian market. CDSCO regulations have been formulated with the goal of safeguarding public health and improving patient care, thereby ensuring effective healthcare delivery. Therefore, securing the CDSCO license for X-ray machines is a mandatory requirement to ensure only safe, effective, and high-quality machines reach the Indian patients.
CDSCO class for X-ray machines
To fast track the CDSCO medical device licensing process, CDSCO has developed a risk-based medical device classification system. Depending on the risk level and intended use, it has categorised medical devices into four classes, Class A, B, C, and D. Hence, based on the risk level and intended use of X-ray machines, CDSCO has classified X-ray machines as Class C medical device. Thus, the application process for CDSCO license for X-ray machines will be per the guidelines for Class C medical devices. Additionally, the applicable license required will be per the Class C medical device requirements.
Different types of CDSCO license for X-ray machines in India
We have highlighted the different licenses you will be requiring for legally manufacturing or importing X-ray machines. Additionally, we have mentioned the application form for the license.
- CDSCO license for manufacturing X-ray machines in India: MD-9 license will be required to manufacture X-ray machines in India. An application has to be filed under Form MD-7.
- CDSCO loan license for manufacturing X-ray machines in India: Manufacturers who do not have a medical device manufacturing facility can apply for the CDSCO loan license. Manufactures seeking to obtain a loan license for manufacturing X-ray machines need to apply using the Form MD-8. CDSCO will grant the approval via Form MD-10.
- CDSCO test license manufacturing X-ray machines in India: CDSCO grants the test license for manufacturing small quantities of medical devices for testing, clinical research, and demonstration purposes. The manufacturer needs to apply for the test license using Form MD-12. CDSCO will grant the test license for manufacturing X-ray machines in India under MD-13.
- CDSCO license for importing X-ray machines into India: MD-15 license will be required to import X-ray machines into India. An application has to be filed under Form MD-14.
Documents required for securing CDSCO license for X-ray machines
We have listed the necessary supporting documents required.
- Cover letter
- Manufacturer’s address and details
- Details and address proof of the applicant
- Power of attorney
- Undertaking proving the authenticity of the details submitted
- Manufacturing site details
- ISO 13485 certificate
- CE design certificate
- Free sale certificate
- Plant master file
- Device master file
- Quality assurance certificate
- TR6 challan
We have provided an overview of the documents required for securing CDSCO license for X-ray machines. Moreover, we at Pharmadocx Consultants provide document preparation service. Our team will help you prepare and compile the necessary supporting documents per the CDSCO guidelines. Additionally, for a detailed list of supporting documents, contact us.
Step-by step guide for CDSCO X-ray machine license application process
We have provided an overview of the CDSCO X-ray machine license application process.
- Login or signup on the official CDSCO online registration portal, SUGAM.
- Fill out the correct application form for the necessary CDSCO license.
- The essential supporting documents need to be prepared and collated per CDSCO regulations for X-ray machines.
- Documents demonstrating quality management system requirement compliance need to be submitted.
- Submit the application form and upload the supporting documents on the online portal.
- The regulatory officials will review the application and verify the documents. If required, the regulatory officials will audit the medical device manufacturing site.
- If all the criteria are satisfied, the regulatory body will approve the application. It will grant the license to manufacture or import X-ray machines under the applicable CDSCO license.
Advantages of having CDSCO license for X-ray machines
Securing the CDSCO license for X-ray machines is a mandatory regulatory requirement. However, it is beneficial for the medical device manufacturer company as well.
- Access to the Indian medical device market: India is being recognised as a potential global hub for medical devices. A CDSCO medical device license will give your company access to the lucrative Indian medical device market.
- Demonstration of device quality and safety: A CDSCO license assures healthcare professionals and patients the medical device meets the standard quality and safety benchmark.
- Brand reputation: Companies selling CDSCO licensed medical devices demonstrate 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 among customers.
Easily secure the CDSCO license for X-ray machines
Entering the Indian X-ray machine market is a lucrative option. However, medical device companies need to comply with all the CDSCO regulations for medical devices. We at Pharmadocx Consultants will guide you through the CDSCO regulations for X-ray machines. Additionally, we will help you select the applicable CDSCO license, prepare necessary documents, and guide you through the application process. Email at [email protected] or call/Whatsapp on 9996859227 to easily secure the CDSCO license for X-ray machines.
