Technology has revolutionized the healthcare industry. Currently, medical devices are not limited to physical devices. Recently, software is being used to monitor, diagnose, prevent, and even treat diseases. New-age technologies, which include software as a medical device, are revolutionizing healthcare. Healthcare regulators worldwide have developed policies to regulate the software being used as medical device. CDSCO, the Indian medical device regulatory body, also has regulations for software as a medical device (SaMD). Software as a medical device in India is regulated to protect the public health. Regulatory approval for software as a medical device is required to ensure its quality and efficacy and protect patient data. Hence, you have to register software as a medical device in India to launch your product in India.
Need to register software as a medical device in India
Similar to any other medical device in India, software being used as a medical device needs regulatory approval and registration in India. Regulatory guidelines are needed to monitor safety, efficacy, quality, and protection of patient data. Whether the software can serve its intended purpose of diagnosing, treating, or managing medical conditions needs to be monitored. Moreover, the ability of the software to safeguard patient information and maintain privacy needs to be monitored. Data accuracy needs to be verified. Furthermore, user interaction and ability to deliver positive user experience need to be validated. Additionally, regulatory approval of software as a medical device needs software validation and verification. Sensitivity of the data involved in medical device software warrants the need for proper regulation of the software.
It is important to verify that the software performs as intended to minimize malfunctions that could harm patients. Accuracy of the data generated by the software is essential for proper diagnosis. Additionally, as doctors use the medical device software to diagnose diseases, confidentiality of patient data and information is important. Hence, regulatory approval of the software as a medical device is necessary. Regulatory guidelines set benchmarks to ensure the software quality, safety, and efficacy are maintained. Globally, countries are regulating medical device software owing to its increased use and impact in the healthcare industry.
In India, Central Drugs Standard Control Organisation (CDSCO), is the apex regulatory body for medical devices. Like all other medical devices, CDSCO regulates and monitors the SaMD. Hence, CDSCO has set regulatory guidelines for software as a medical device. These guidelines are essential for improvement of patient outcome as well as advancement of healthcare industry. Thus, it is mandatory to register software as a medical device in India to market your product.
Register software as a medical device in India
To register software as a medical device in India, it is important to understand the CDSCO definition for a SaMD. Additionally, it is important to understand whether your software will be considered a medical device in India. As per Medical Device Rules, 2017, a software as a medical device is a software used to treat, diagnose, mitigate, cure, or prevent disease or other conditions. It can be a software technology or mobile app. It can used as a standalone technology or can function in combination with other software. A software is considered a medical device in India if the software is used to:
- Diagnose, prevent, monitor, treat, or alleviate any disease or disorder
- Investigate, replace, modify, or support the anatomy or a physiological process
- Support or sustain life
- Assist individuals with injury or disability
- Assist in the control of conception
- Disinfect medical devices
A software will be considered a medical device only if it was developed with the intention of using it for medical purposes. Additionally, it should meet the Medical Device Rules definition for medical devices. Only after you confirm your software will be considered a SaMD in India, do you need to obtain the CDSCO license for SaMD.
CDSCO classification for SaMD in India
CDSCO has classified SaMD into four classes: Class A (low risk), Class B (low to moderate risk), Class C (moderate risk), and Class D (high risk) devices. The CDSCO SaMD classification system is based on associated risk level and intended use. To register software as a medical device in India, the first step is to identify the CDSCO SaMD class. The CDSCO class will determine the CDSCO medical device license required to manufacture the SaMD in India.
- Class A: The Class A software does not directly interfere with patient data. It is a software that retrospectively analyses pre-recorded clinical data of patients. Example: A software used to retrospectively analyse data collected by a glucose monitor.
- Class B: The Class B software generates real time patient information based on patient’s parameters. Example: A software that creates, analyses, and displays electrocardiograph data to detect irregular heartbeats.
- Class C: The Class C software can be used to diagnose diseases and analyse patient’s physiological and physical activity. The data generated can be used to treat a patient. Example: Orthodontic software.
- Class D: CDSCO has not yet classified any software as high risk.
Documents required to register software as a medical device in India
We have provided an overview of the documents required for securing CDSCO license for SaMD products in India.
- Sale deed/rent deed of the premises proving the legal ownership of the medical device manufacturing facility.
- Organization identity proof, such as memorandum of association, list of directors or partners, UDYAM Aadhar, or PAN card.
- Facility layout with dimension. A detailed drawing of the medical device manufacturing facility with the dimensions of each room and the location of all equipment.
- ISO 13485 certificate
- Plant master file containing information about the layout of the facility.
- Device master file contains detailed information about the software, including its design, development process, testing procedures, and validation
- Certificate of analysis demonstrating the software meets the required quality standards
- Details and qualification of technical staff who will manufacture and test the medical devices
- Test license for the SaMD, if required
We have provided an overview of the documents required for securing CDSCO license for SaMD products. Feel free to get in touch for a detailed list of documents required for CDSCO SaMD license application. Additionally, we will help prepare and compile the documents per CDSCO guidelines.
CDSCO license for manufacturing SaMD in India
- To manufacture Class A and Class B SaMD in India, CDSCO MD 5 license must be secured from the state licensing authority.
- To manufacture Class C and Class D SaMD in India, CDSCO MD 9 license must be secured from the central licensing authority.
CDSCO license for importing SaMD into India
To import SaMD into India, CDSCO MD 15 has to be secured from the central licensing authority.
Step-by-step guide to register software as a medical device in India
- Check whether the software qualifies as a medical device
- Check the CDSCO class for the SaMD, as this will determine the application form and requirements.
- Login or create an account on CDSCO’s SUGAM Portal.
- Fill in the respective application forms
- Compile and upload the necessary supporting documents. Additionally, pay the required fees.
- The application will be reviewed and the documents will be verified by the regulatory authorities. Furthermore, the regulatory authorities may conduct an audit.
- If the regulatory officials are satisfied and no non-compliance is observed, then the application will be approved. Then, the CDSCO license for SaMD products will be granted.
Validity of CDSCO license for SaMD
The CDSCO license for SaMD remains valid indefinitely. However, a license retention fee has to be paid every 5 years to maintain validity.
Need help to easily register software as a medical device in India? Email at [email protected] or call/Whatsapp on 9996859227 and we will be more than happy to help.
