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 securing the CDSCO license for MRI machines in India? Well, look no beyond. We have prepared this guide to help you sort your MRI machine CDSCO license application.
MRI: A vital medical imaging device
Magnetic resonance imaging (MRI) machines play a critical role in enhancing patient care. It 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. Thus, they help take informed decisions by providing a non-invasive three-dimensional internal view of the human body. This imaging technique is used to generate images of the anatomy and physiological processes of the body. Moreover, MRI is one of the vital diagnostic imaging medical devices for early diagnosis of diseases and monitoring treatment progress.
Demand for MRI machines in India
The demand for MRI machines in India is increasing steadily. 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. The Indian government is considerably investing in improving the healthcare infrastructure. It has collaborated with major players to facilitate installation of advanced MRI equipment in healthcare facilities across the country. This is the key factor fuelling demand for MRI machines in India.
High neurological disorder prevalence in India is driving the demand for early diagnosis using MRI. MRI plays a role in Alzheimer’s disease and mild traumatic brain injury diagnosis and monitoring. Furthermore, application of MRI machines in oncology field is expected to grow at a significant rate. It can generate detailed images of internal structures, which can be used to identify and evaluate tumours and other abnormalities. Thus, MRI machines are in high demand in India, especially in the oncology and neurology fields. Therefore, all these factors are augmenting the Indian MRI machine market.
However, the Indian MRI machine market is highly competitive. Several major players are currently dominating the market. 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 MRI machine sector in India. Thus, manufacturing high-end affordable MRI machines in India would reduce import dependency, thereby reduce the cost.
Indian MRI machine market: A lucrative sector
The Indian MRI machine market has a bright future, owing to the high demand for these machines in the healthcare sector. However, the market is majorly import dependant. Manufacturing low-cost and high-quality MRI machines in India would address the affordability issues. Hence, the MRI machine sector is a lucrative market for medical device companies.
CDSCO regulations for MRI machines in India
Central Drugs Standard Control Organisation (CDSCO) regulates all medical devices, pharmaceuticals, and cosmetics entering the Indian market. It functions under the purview of Medical Device Rules, 2017. The CDSCO aims to ensure inferior-quality medical devices do not enter the Indian market. Substandard machines can lead to inaccurate diagnosis, thereby incorrect treatment and negative patient outcome. Thus, the regulatory body is aimed at protecting the public health by formulating strict regulatory guidelines for medical devices. Mandatory CDSCO licensing for all medical devices assures the medical professionals of the quality of the machines they are using. Therefore, CDSCO has formulated strict regulatory guidelines for MRI machines in India. Hence, it is mandatory to secure the CDSCO license for MRI machines to legally launch your products in India.
CDSCO class for MRI machines
CDSCO has developed risk-based medical device classification system. Depending on the risk level and intended use, CDSCO has classified MRI machines as Class C medical device. Hence, the application process for CDSCO license for MRI machines will be per the guidelines for Class C medical devices.
CDSCO license for MRI machines in India
We have highlighted the different licenses you will be requiring for legally manufacturing or importing MRI machines in India.
- CDSCO license for manufacturing MRI machines in India: MD-9 license will be required to manufacture MRI machines in India. An application has to be filed under Form MD-7. The CDSCO will grant the license to manufacture MRI machines in India under the MD-9 license.
- CDSCO license for importing MRI machines into India: MD-15 license will be required to import MRI machines into India. An application has to be filed under Form MD-14. The CDSCO will grant the license to import MRI machines into India under the MD-15 license.
- CDSCO loan license for manufacturing MRI machines in India: Manufacturers not having a medical device manufacturing facility can apply for the CDSCO loan license. Manufactures seeking to obtain a loan license for manufacturing MRI machines need to apply using the Form MD-8. CDSCO will relay the approval via Form MD-10.
- CDSCO test license manufacturing MRI 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 MRI machines in India under MD-13.
Supporting documents required for securing CDSCO license for MRI machines
We have provided an overview of the necessary supporting documents required for applying for CDSCO medical device license.
- 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
- ISO 13485 certificate
- CE design certificate
- Free sale certificate
- Plant master file
- Device master file
- Quality assurance certificate
We have provided a skeletal overview of the documents required. For a detailed list of supporting documents, get in touch with us. Additionally, we will help you prepare them per CDSCO guidelines for document preparation.
Application process for CDSCO license for MRI machines
We have provided an overview of the CDSCO MRI machine license application process.
- The 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 be submitted.
- The regulatory officials will review the application and verify the documents. If applicable, the officials will inspect the site to audit the manufacturing facility.
- If all the criteria are satisfied, the regulatory body will grant the applicable license.
Do you want to easily secure the CDSCO license for MRI machines?
We at Pharmadocx Consultants specialise in CDSCO medical device licensing. Our team has extensive regulatory knowledge and industry expertise. Our expertise in this field will ensure your CDSCO medical device licensing process is free from regulatory hurdles. Email at [email protected] or call/Whatsapp on 9996859227 to easily secure the CDSCO license for MRI machines in India. We will help you select the applicable CDSCO license, prepare necessary documents, and guide you through the application submission process. Moreover, our support does not end with application submission. We will provide guidance till you successfully secure the CDSCO license. Furthermore, we will help you design and set up your manufacturing facility.
