Navigating the Regulatory Landscape: SiMD and SaMD in India

Dr C. Sheela Sasikumar

Managing Partner SS Clini Research LLP

Director of Research and Education Dr. RK's

E-mail: [email protected]

When writing articles on healthcare, my primary focus is always on the patient

My Mantra -"In Healthcare Research, Ethics Illuminate the Path, Safety Guards the Journey, and Efficacy Fuels the Destination."

In the rapidly evolving field of digital health, understanding the distinctions between Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD) is crucial. Both play significant roles in enhancing medical diagnostics and treatment, but they differ fundamentally in their integration and functionality.

Definitions

Software in a Medical Device (SiMD):

• Definition: SiMD refers to software that is an integral part of a medical device’s hardware. It operates within the device, contributing to its primary medical function.
• Examples: Firmware in infusion pumps, software in MRI machines, and embedded systems in pacemakers that control device functions.

Software as a Medical Device (SaMD):

• Definition: SaMD is standalone software that performs medical functions independently of any physical medical device. It can be used on general-purpose computing platforms like smartphones or computers.
• Examples: Mobile health applications for diagnosis, software for remote patient monitoring, and clinical decision support systems.

Key Differences

Integration:

1. SiMD: Integrated directly into the hardware of a medical device. It is designed to control or enhance the functionality of the physical device.
2. SaMD: Operates independently of physical medical devices, often running on standard computing platforms.

Functionality:

1. SiMD: Functions are closely tied to the physical medical device’s operation, such as controlling device actions or processing data generated by the device.
2. SaMD: Performs medical functions on its own, such as diagnosing conditions, monitoring health metrics, or aiding in clinical decisions.

Deployment:

1. SiMD: Deployed as part of a medical device, with updates typically managed through the device manufacturer.
2. SaMD: Can be deployed and updated independently, often through app stores or direct downloads.

Regulatory Pathways:

1. SiMD: Regulated as part of the overall medical device, with the software being a component of the device’s approval process.
2. SaMD: Subject to its own regulatory pathway, focusing on the software’s medical function and intended use.

Classification of SaMD Devices

SaMD devices are classified based on the risk they pose to patients and the intended medical function. The classification framework helps in determining the regulatory requirements for these devices.

Class A (Low Risk):

• Characteristics: Do not directly interfere with patients’ data.
• Examples: Retrospective data analysis software that uses pre-recorded clinical data to study various correlations.

? Class B (Moderate Risk):

• Characteristics: Provides real-time information on patient parameters but is not intended for clinical diagnosis.
• Examples: Electrocardiograph software for home use.

Class C (Moderate to High Risk):

• Characteristics: Directly aids in diagnosing disease conditions and analyzing a patient's physiological activity.
• Examples: Orthodontic software.

Class D: In India, the CDSCO has not yet identified any SaMDs posing high risk to patients.

Use Cases

SiMD:

• Diagnostic Devices: Software in imaging devices like CT scanners that process images.
• Therapeutic Devices: Software in insulin pumps that controls dosage delivery.
• Monitoring Devices: Software in cardiac monitors that analyzes heart rhythms.

SaMD:

• Diagnostic Applications: Apps that use algorithms to diagnose skin conditions based on images.
• Monitoring Applications: Software that tracks patient vital signs remotely and alerts healthcare providers.
• Clinical Decision Support: Tools that analyze patient data to assist doctors in making treatment decisions.

Regulatory Guidelines for SaMD in India

When marketing Software as Medical Devices (SaMD) in India, compliance with the following regulations is mandatory:

• Medical Device Definition: As per S.O. 648(E) released on February 11, 2020.
• Medical Device Rule, 2017
• ISO 13485:2016: Quality management system.
• ISO 14971:2019: Application of Risk Management to Medical Devices.
• Post-Market Surveillance (PMS)
• Clinical Evaluation Report

Globally Harmonized Standards:

• IEC 62304: Software Life Cycle Process.
• IEC 60601-1: Applies to embedded software in hardware medical devices.
• IEC 82304-1: Applicable to standalone software (SaMD).
• IEC 81001-5-1: Deals with cybersecurity.
• IEC 62366-1: Requirements for man-machine interface ergonomics.

Regulatory Requirements

1.???? Registration and Licensing:

1. Importer and Manufacturer Licensing: Entities involved in the import or manufacture of SaMD must obtain appropriate licenses from the CDSCO.
2. Device Registration: SaMD must be registered with the CDSCO, following the risk-based classification system.

2.???? Pre-market Approval:

1. Device Classification: Identify the classification of the SaMD based on intended use and risk.
2. Clinical Evaluation: Conduct clinical evaluations to demonstrate the safety and effectiveness of the software.
3. Technical Documentation: Prepare and submit comprehensive technical documentation, including software specifications, risk management plans, and clinical data for CDSCO review.

3.???? Post-market Surveillance:

1. Adverse Event Reporting: Establish a system for monitoring and reporting adverse events associated with the use of SaMD.
2. Periodic Safety Update Reports (PSURs): Submit PSURs to the CDSCO, detailing the safety and performance of the software.
3. Recalls and Corrective Actions: Develop procedures for product recalls and corrective actions in case of safety issues.

4.???? Labeling and Instructions for Use:

1. Labeling Requirements: Ensure that the software labeling complies with CDSCO guidelines, providing clear instructions for use, intended purpose, and any warnings or precautions.
2. User Training: Provide adequate training to users on the proper use and maintenance of the software.

5.???? Data Privacy and Security:

1. Data Protection: Implement robust measures to protect patient data and ensure compliance with data privacy regulations.
2. Cybersecurity: Develop and maintain cybersecurity protocols to protect software from unauthorized access and cyber threats.

6.???? Compliance and Audits:

1. Regulatory Audits: Be prepared for periodic audits by CDSCO to ensure compliance with regulatory requirements.
2. Corrective and Preventive Actions (CAPA): Establish CAPA processes to address any non-compliance issues identified during audits

Conclusion

The introduction of specific regulations for SaMD by the CDSCO marks a significant step towards ensuring the #safety, #efficacy, and #quality of digital health technologies in India. By adhering to these guidelines, manufacturers and developers can navigate the regulatory landscape effectively, contributing to the advancement of healthcare innovations while ensuring patient safety and data protection.

Author: Dr. C Sheela Sasikumar is a renowned expert in clinical research and healthcare innovation. With extensive experience in the medical device industry, Dr. Sasikumar provides valuable insights into regulatory compliance and digital health technologies. For further information or inquiries, please contact Dr. C Sheela Sasikumar at [email protected].

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