The Central Drug Standard Control Organization (CDSCO) is the National Regulatory Authority (NRA) of India. It works under the Directorate General of Health Services, under the Ministry of Health and Family Welfare, Government of India. It is regulated by the Drugs and Cosmetics Act and is responsible for the approval of drugs, laying down their standards, conducting clinical trials, taking control over the quality of Imported Drugs, etc. The Ministry of consumer affairs had made a proposal to mandate the CDSCO Medical Device Registration for X-Ray Machine under Medical Device Rules, 2017, as well as under other standards set by the Bureau of Indian Standards. With effect from 1st January 2021, All the X-ray machines fall under the category of mandatory registration of CDSCO Medical Devices.
X-Ray Machine as Medical Device
The system of medical imaging has helped in the timely treatment and diagnosis of various medical issues among patients. There are many ways of medical imaging, such as- CT, Fluoroscopy and Radiography, where all of these include ionizing radiation in order to generate body images. Body imaging devices work on one procedure, where an X-ray beam is passed through the affected body part. The X-rays are then absorbed by the internal structure, and the remaining X-ray beam reaches the detector for creating the X-ray images by the computer.
X-Rays are often used to check images of teeth and bones, to check for any kind of breaks, cracks, fractures or even diseases such as arthritis. An X-ray can also be prescribed to check the digestive tract by evaluating the organs inside the chest, lungs, heart and breasts.
The X-Ray machines are divided into three main types-
- Fixed X-ray machines
- Portable X-ray machines
- Mobile X-ray machines
Medical Device Regulation in India
The medical device market sector is an important and essential part of the Healthcare sector in India, particularly for the purpose of preventing, diagnosing, managing and medical treatments of severe conditions, disabilities, diseases and Illnesses. It is an important support system in the healthcare unit and helps in achieving the important functions of the National Health Policy (NHP) 2017, and helps in providing good quality, reasonable and comprehensive healthcare services in India.
According to the notification number 648 (E) published in The Official Gazette of India by the Directorate General of Health Services It was notified that the following medical devices would be considered as Drugs from 1st April 2020-
“All the devices that are Instrument, appliance, apparatus, material, implant or any other tool, which is used either alone or in combination with other device, software or accessory and Is used specifically for humans and animals, which do not achieve the primary intended action in or on animal or human body by any pharmacological or Immunological or metabolic means, but which may help in its intended function by such means for one or more specific purpose of-”
- Diagnosis, monitoring, prevention, alleviation or treatment of any disorder or disease
- Diagnosis, monitoring, treatment or alleviation of any disability or Injury
- Replacement, investigation, support or modification of a physiological process or of the anatomy
- Life support and sustaining
- Medical Device disinfection
- Conception control
According to the notification, the intended use of the X-ray machine is to diagnose, monitor and treat any disability or Injury of the patient by capturing images of the internal body structure. Therefore, CDSCO Medical Device Registration for X-Ray Machine is mandatory as per MDR, 2017.
Classification of Medical Devices in Medical Device Rules, 2017
The X-Ray device is classified as a Class C medical device as per the Risk-based classification of the Medical Device Rules, 2017.
CDSCO has set up different classes of medical devices as per their risk classification. The Drug Controller General of India (DCGI), who is the head of CDSCO, is responsible for regulating different classes of medical devices as per Medical Device Rules, 2017. The classification of the Medical Device is risk-based and is classified into four types- Class A, Class B, Class C and Class D Medical Device, where the level of risk increases as it moves from Class A to Class D. Following table lists the classification of medical devices on the basis of the risk involved-
|Class A Medical Devices
|Class B Medical Devices
|Class C Medical Devices
|Class D Medical Devices
Regulatory authorities of X-Ray machines as Class C Medical Devices in India
The Authorities who are responsible for regulating the CDSCO Medical Device Registration for X-Ray Machine in India are:
- Central Drug Standards Control Organization (CDSCO)
- Drug Controller General of India ( DCGI)
- Drugs & Cosmetic Act 1940 & Rules 1945
Documents required for CDSCO Medical Device Registration for X-Ray Machine
- Application Form (Form 40)
- ISO 13485 Certificate
- TR6 Challan
- Undertaking that only authentic details are provided
- Power of attorney
- Full quality assurance certificate
- CE Design certificate
- Schedule D(I)
- Declaration of conformity
- Device master file
- Free sale certificate
- Plant master report
- Free sale certificate/ certificate from the foreign government
Procedure for CDSCO Medical Device Registration for X-Ray Machine
Earlier, there were no rules for regulating medical devices in India, and they were sold in the market without any regulations. Post-2006, the CDSCO made a rule that all the medical devices circulated in the market must be in compliance with CDSCO. The mandatory compliances made it important for certain Medical Devices to be registered with CDSCO before manufacturing, selling or importing into the Indian market. Following are the steps to be followed for CDSCO Medical Device Registration for X-Ray Machine in India-
- Determine whether the Medical Devices require registration or not: The first step is to check with the Medical Devices and IVDs list to check if the medical device is notified or not. All the notified medical devices are required to obtain registration before they are marketed in India. In this case, the X-Ray machines fall under the category of notified devices and must be registered with CDSCO
- Risk-Based Classification of Medical Devices: The notified devices which are required to be registered with CDSCO are then identified on the basis of risks involved with them. The X-ray machines fall in Class C of risk-based categorization of Medical Devices, because they involve Medium-High level risk.
- Appointment of Indian Authorized Agent (IAA): An Indian Authorized Agent is appointed in case the manufacturer is not an Indian. The IAA acts as a representative on behalf of the manufacturer to conduct all his official duties in India.
- Technical Documentation: All the necessary documents are required to be submitted to the respective authorities in order to obtain a registration license.
- Obtain Registration and License: After all the necessary documents are submitted to the correct authorities, the registration license is obtained by the manufacturer.
Timeline for CDSCO Medical Device Registration for X-Ray Machine
The general timeline for CDSCO Medical Device Registration for X-Ray Machine is 6-9 months after completing the application process. The registration remains valid for three years. If in case of renewal, the applications are required to be submitted six months from the date of expiry.
The X-Ray machine business has grown up to 312.84 million dollars in India in the year 2021 and is expected to grow at a CAGR of 7.04% in the current period. New product launches and technological advancements are expected to create market growth for medical devices in India. Since X-Ray machine falls in the category of Class-C Medical devices, there is a mandatory requirement for registration. However, the slightest error in the registration process may cause the rejection of the application. Therefore, it is always advisable to get professional help for the purpose of CDSCO Medical Device Registration for X-Ray Machine.
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