The world, post the Covid-19 pandemic, has seen a surge in the integration of technology in the healthcare industry to diagnose, treat, monitor, and prevent diseases. The Medical Device Rules, 2017, has been drafted on the basis of the European Union Medical Devices Regulations and the Food and Drug Administration of USA and is the regulatory framework for the manufacture and sale of and to govern the quality and safety standards of medical devices in India. Scroll down to check the development of Software as a Medical Device.
Software as a Medical Device
The Central Drugs Standard Control Organization (CDSCO), through a notification in 2020, extended the scope of the devices covered under the Drugs and Cosmetics Act and The Medical Devices Rules, 2017 to include Software as a Medical Device (SaMD) in India. According to the Drugs and Cosmetics Act, for Software to qualify as a medical device, it should be used for:
- Assistance in providing relief to any disability or injury.
- Diagnosing, treating, preventing, or mitigating and disorder or disease.
- Sustaining or supporting life.
- Conception control.
- Support, replacement, investigation or modification of a physiological process or anatomy.
- Disinfecting medical devices.
The International Medical Devices Forum defines SaMD as Software which can be used for many medical purposes like diagnosis, treatment, prevention and mitigation of diseases and disorders, but without being a part of a hardware medical device. Medical device software helps in the screening of disorders and diseases and their diagnosis, management of diseases, monitoring the condition of patients and sending alerts to healthcare workers when needed and helping them decide which route to take with respect to treatment and medication.
Software used in Medical Devices (SiMD), is different from Software as a Medical Device, which has been defined by the International Medical Devices Forum as Software which is a part of another hardware medical device and pertains to Software which processes data, regulates the processes, functions and mechanics of a medical device or is essential for the operation of the medical device.
For Software as a Medical Device to be marketed in India, it must comply with certain regulations, standards, and applicable global standards like:
- ISO 14971:2019 – Application of Risk Management to Medical Devices
- ISO 13485:2020 – Quality Management Systems
- Medical Device definition as provided in the 2020 notification brought out by CDSCO
- Medical Device Rules, 2017
- IEC 62304, which is the international standard for Software in medical devices and deals with software lifecycle management
- IEC 82304-1, which is the international standard which applies specifically to Software as a Medical Device
- IEC 60601-1, which is the international standard applied to Software embedded in hardware devices
- IEC 62366-1, which is the international standard which applies to ergonomics of the machine-man interface.
- IEC 81001-5-1 which is an international standard which provides for cybersecurity
As per the Medical Device (Amendment) Rules, 2020, the importers and manufacturers of medical devices have to get such devices registered to manufacture, sell, import, export or distribute or allow intermediaries to deal similarly with such medical devices in the Indian market. The CDSCO, in 2021, released certain guidelines based on which SaMD must be classified according to the risk-based classifications as provided for by the International Medical Devices Forum. For registration purposes, Software as a Medical Device are divided into four classes based on the risk they possess:
- Class-A: Low-risk software which does not interfere or interpret the patient’s medical data
- Class-B: Low to moderate-risk software which provides comprehensive information about the parameters of the patient but is not used to give a medical diagnosis
- Class-C: Moderate-risk software which helps in diagnosing diseases and analysing the physiological activity of the patient
- Class-D: High-risk software
Steps involved in the Development of Software as a Medical Device
A creator of Software as a Medical Device must follow the following steps while developing SaMD:
In this step, the conditions and terms of the device are evaluated, the cost of material, cost of labour is assessed, teams are formed, and timelines are created with a view to achieving a certain goal. It also involves taking advice and feedback from potential customers, investors, and medical experts.
- Defining requirements of the Software as a Medical Device
This step forms part of the planning and involves deciding the purpose of the medical device and the resources required for its development, like, inter alia, the professionals who shall develop the product and the machinery needed to develop the same.
- Creating the Design and Prototype of the Medical Device
The design step includes many sub-steps, which involve creating the architecture, the user interface, programming, and platforms and deciding on security measures for the Software. This step involves, inter alia, creating the programming language, algorithms to be used, template and design of the Software, creating an efficacious and user-friendly interface, choosing the platform on which such Software shall run and deciding on the data protection norms and putting in strict protective measures to secure the Software from cyber-crimes.
A prototype is then to be created to, which shall be assessed and tested continuously for improvement.
- Medical Device Software Development
This step involves the actual development of the Software using the programming language and algorithms.
- Testing of the Software as a Medical Device
Since the product is to be used in the healthcare industry, before deploying the Software into the market, it is imperative to conduct rigorous scrutiny and testing. This majorly involves, inter alia, testing the performance of the Software, assessing the code, recording and correcting lagging issues, if any, and checking the efficacy of the security measures.
- Registration of the Software as a Medical Device
It is imperative for the manufacturers or importers of Software as a Medical Device to get it registered with the CDSCO to manufacture, sell, import, export or distribute or allow intermediaries to deal similarly with such medical devices in the Indian market before marketing such SaMD. Non-registration can lead to penalties under the Drugs and Cosmetics Act 1940.
Prior to obtaining such registration, the Government of India has mandated that medical devices sold in the Indian market have to adhere to the ISO 13485 (Quality Management System standard for medical devices), which shall be certified by the accredited certifying body.
- Deployment of the Software as a Medical Device
The Software is introduced in the intended market for usage by healthcare professionals and other users.
- Operation and Maintenance of Software as a Medical Device
Once the Software is introduced in the market, it must be monitored to check and fix any deficiencies and bugs which slipped through the cracks during the testing stage.
- Surveillance of the Market
Once the Software as a Medical Device has been in the market for a while, the creators must be on the lookout for possible adverse effects and problems caused to the users and look for ways to fix them.
Given the surge in technological advancement in the healthcare sector, there have been major developments in innovation pertaining to medical devices, including Software as medical devices. Keeping in mind these advancements, the Government of India has increasingly been focusing on regulating the registration, manufacture, sale, import, export, or distribution of such medical devices by amendments to the Drugs and Cosmetics Act,1940 and the Medical Device Rules, 2017. The development of SaMD is a very niche area that is stated to rise exponentially. Developers looking to venture into this field must be aware of not only the processes involved but also keep abreast with various legal, regulatory and policy compliances in order to deploy safe and quality products in the healthcare sector and avoid penalties.
Read Our Article: Registration of Software as Medical Device in India