Magnetic Resonance Imaging (MRI) is an excellent non-invasive diagnostic imaging tool. It is used for detection of various diseases by providing precise contrast resolution. Additionally, it is used for treatment monitoring. MRI uses a sophisticated technology. It produces a strong magnetic field that forces the protons in the body to align with that field. MRI is used to produce 3D image of the brain, spinal cord, nerves, muscles, ligaments, and tendons. Hence, MRI machines are in high demand in the healthcare sector. Thus, MRI manufacturing industry is a high potential sector. Therefore, medical device companies can venture into manufacturing MRI machines to cater to the healthcare sector’s diagnostic imaging needs.
Doctors use MRI machines to diagnose and select the treatment for various heart, brain, and orthopaedic conditions. Owing to their role in non-invasive diagnostic imaging, MRI machines are in high demand in India. With increase in focus on improving the healthcare industry, the government is investing in high-end medical devices, such as MRI machines. The MRI manufacturing industry is dominated by few global players. Hence, the machines are expensive and inaccessible to most in India. Owing to high costs, most individuals in India cannot afford MRI diagnosis. Therefore, innovative technologies for manufacturing low-cost, high-quality, and effective MRI machines have to be developed. Medical device companies have to focus on domestically manufacturing MRI machines in India to make MRI machines affordable and accessible to all.
Types of MRI machines
MRI, X-rays, and CT scans are the three commonly used imaging techniques. MRI creates detailed 3D images of the organs and tissues within the body with the help of powerful magnetic field and radio waves. It creates a detailed cross-sectional image of interior organs and structures. Notably, MRI does not employ potentially dangerous ionizing radiation as opposed to CT scans and X-rays. For manufacturing MRI machines, it is vital to have a knowledge of the common types of MRI machines available in the market. There are 2 major types of MRI machines:
- Open bore MRI: Open bore MRI has two flat magnets positioned over and under the patient. The patient will lie in the large space between the magnets for imaging.
- Closed bore MRI: Closed bore MRIs have a ring of magnet that forms a tube in the middle for the patient to lie in for capturing images. However, closed bore MRIs have a disadvantage. Being narrow and closed, they may cause anxiety and discomfort for few patients.
Manufacturing MRI machines
What is the process of manufacturing MRI machines?
We have provided an overview of the process of manufacturing MRI machines. Additionally, we have highlighted the components required.
MRI machine components and how they are constructed
- Radio frequency system: The electronic parts for the radio frequency system has to be purchased. Then, the radio frequency coils that are of different configurations have to be attached to the electronic parts. The gradient coils’ material is used in the transmitter and receiving coils. They are constructed in a manner similar to the primary magnet.
- The magnet: Superconducting electromagnets are used to construct the MRI system. The design of the MRI system involves coil of conductive wire, cooling system, and power supply. The coils are submerged in a container with liquid helium. Then, the coils become superconductive owing to the drop in temperature, as they are submerged in liquid helium. Two more vessels containing various coolants, such as liquid nitrogen, have to be placed around the first vessel to help maintain the temperature. After which, this assembly is suspended in a vacuum-sealed container using thin rods. Then, the magnetic coils have to be connected to a power supply. The power supply will be used to activate the magnet when it is necessary.
- Gradient coils: Three sets of gradient coils are used in the MRI system. Thin strips of copper or aluminium are wound to create each coil. The gradient coils are electromagnets of the resistive type. Moreover, epoxy is usually incorporated into the coils’ structure to increase their strength.
- Display system: The MRI machine requires a display system. This system displays the data. Fourier transformer, signal converter, preamplifier, and user interface are all connected to this display system.
Notably, owing to the magnet’s nature, additional handling considerations, such as transportation in an air-suspended vehicle, have to be kept in mind. Each component of the MRI has to be carefully constructed and assembled in a proper frame.
CDSCO regulations for manufacturing MRI machines in India
Central Drugs Standard Control Organisation (CDSCO) is the apex regulatory body for all medical devices in India. CDSCO has chalked out stringent regulations for manufacturing MRI machines in India. Substandard and poor-quality machines will hamper the diagnosis, thereby negatively impact patient outcome. Hence, CDSCO regulations for MRI machines ensure medical device companies do not sell substandard medical devices. Indian regulations for MRI machines fall under the purview of Medical Devices Rules, 2017. CDSCO registration for MRI machines is mandatory to sell and distribute them in India. Thus, CDSCO registration for MRI machines will ensure patients in India have access to high quality and effective machines.
The primary goal of CDSCO regulations is to ensure the quality, efficacy, and safety of the device are consistently maintained. The Indian medical device regulation is aimed at effective healthcare delivery and improved patient care. The regulations for manufacturing MRI machines in India protect the public health. To market your MRI machines in India, you will need mandatorily a CDSCO registration.
CDSCO class for MRI machine
To fast track the CDSCO medical device 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, MRI machines have a medium to high level of risk. Hence, depending on the risk level and intended use, CDSCO has classified the MRI machines as Class C. The registration process will be per the guidelines and requirements for CDSCO Class C medical devices.
CDSCO license for manufacturing MRI machines in India
Securing the CDSCO license for manufacturing MRI machines is compulsory to legally sell your products in India. As MRI machines have been classified as CDSCO Class C, MD 9 manufacturing license will be required to manufacture MRI machines in India.
Necessary supporting documents required for securing CDSCO registration for MRI machines
- Cover letter
- Application form
- Details and address proof of the applicant
- Power of attorney
- Undertaking demonstrating only authentic details have been provided
- Quality assurance certificate
- ISO 13485 certificate
- CE design certificate
- Plant master file
- Device master file
- Free sale certificate
- TR6 challan
The above list provides a basic outline of the documents required for securing CDSCO license for manufacturing MRI machines in India. Get in touch with us for a detailed list of documents required for CDSCO MRI machine manufacturing license application. Additionally, our team will help you prepare and compile the documents per CDSCO regulations.
Choose Pharmadocx Consultants to easily secure your CDSCO license for manufacturing MRI machines in India
To start an MRI machine manufacturing business in India, you need to understand the CDSCO regulations for MRI machines in India. The regulations can be difficult to comprehend. The CDSCO registration process can be tricky from choosing the correct form, filling the form correctly to preparing the necessary documents. The Pharmadocx Consultants team can make the process of securing CDSCO license for manufacturing MRI machines in India hassle free. Drop an email at [email protected] or call/Whatsapp on 9996859227.
