The field of healthcare technology is always changing, and as such, the need for comprehensive regulations around Software as a Medical Device (SaMD) is on the rise. The Central Drugs Standard Control Organization (CDSCO) gives clear-cut requirements for the registration and compliance of SaMD in India as per the regulations established in the country.
With the merging of technology and medical practices, the balance between SaMDs and keeping safety and efficacy standards while practicing is critical. In this article, we discuss the essential technical file requirements for SaMD in the pharmaceutical sector to help developers and stakeholders navigate through the critical paths for developers to bring their SaMD to the market safely and effectively.
What is Software as a Medical Device (SaMD)?
Software as a Medical Device (SaMD) is a term used to describe any software with a medical purpose that is intended to perform that function independently, without being embedded in a hardware medical device. SaMD is designed to assist in the diagnosis, prevention, follow-up, treatment, and relief of disease and conditions. In India, SaMD is under Medical Device Rules, 2017, and is regulated by the Central Drugs Standard Control Organisation (CDSCO).
Technical File Documentation Requirements
SaMD developers must prepare a comprehensive technical file that demonstrates compliance with regulatory standards. The following documents are required:
- Manufacturer Contact Information: The name, address, and contact information of the manufacturer.
- Device Description: All information related to the software, including its use, features, and functionalities.
- Classification Information: SaMD is classified into four categories based on risk levels:
| Class | Risk Level | Description |
|---|---|---|
| A | Low Risk | Software that does not directly interfere with patient data. |
| B | Moderate Risk | Provides real-time information but does not make clinical diagnoses. |
| C | Moderate High | Assists in diagnosis and analysis of physical activity. |
| D | High Risk | Currently unclassified by CDSCO. |
Each class has specific licensing requirements that must be adhered to before the software can be marketed.
- Regulatory Compliance Documents: Proof of compliance with applicable standards and regulations, for example, ISO 13485 (Quality Management Systems) and ISO 14971 (Risk Management)
- Clinical Evaluation Report: Compilation of evidence of the safety and effectiveness of the software based on clinical data.
- Risk Management Report: A comprehensive report outlining the potential risks involved in the software and the strategies to mitigate them.
- Software Development Lifecycle Documentation: Documentations addressing every phase from design and development to maintenance and post-market surveillance
- Post-Market Surveillance Protocols: Drafting all the plans that determine how the software will be monitored after the launch to ensure effectiveness and safety.
SaMD Licensing Requirements
To register SaMD in India, developers must obtain the appropriate licenses from CDSCO:
| Software Class | License Required | Issuing Authority |
|---|---|---|
| Class A & Class B | MD 5 License | State Licensing Authority |
| Class C & Class D | MD 9 License | CDSCO |
| Importing SaMD | MD 15 Import Registration | CDSCO |
- Class A and Class B Software: Requires an MD 5 License from the State Licensing Authority.
- Class C and Class D Software: Requires an MD 9 License from CDSCO.
- Importing SaMD: An MD 15 Import Registration is necessary for importing software into India.
Registration Process
The registration process for SaMD in India involves several steps:
- Determine Classification: Assess whether the software qualifies as Software as a Medical Device and classify it according to risk.
- Gather Required Documentation: Compile all necessary documents, including those mentioned above.
- Submit Application: Complete the application process through CDSCO, ensuring all information is accurate and complete.
- Post-Market Surveillance: Implement a plan for ongoing monitoring of the software’s performance in the market.
Also Read – What is the EU Medical Device Regulation (MDR)?
Compliance with Global Standards
In addition to local regulations, SaMD must also comply with internationally recognized standards such as:
- IEC 62304: Governs the software lifecycle processes. This is a key standard for SaMD licensing, ensuring the production and maintenance of safe and effective software medical devices.
- IEC 60601-1: Addresses safety and performance requirements for medical electrical equipment. While important for medical devices in general, it is most relevant when the SaMD interacts with or controls medical electrical equipment.
- IEC 82304-1: Pertains specifically to standalone software safety requirements. This standard addresses the safety requirements for standalone software used as a medical device.
- ISO 13485:2016: Focuses on quality management systems (QMS) specific to medical devices. Compliance with ISO 13485:2016 is highly recommended to fulfill regulatory requirements for SaMD in multiple countries. Having a QMS is crucial for teams to stay on track and record the development of their device from start to finish, streamlining the demonstration of procedures and standards like ISO and IEC.
- ISO 14971: Provides guidelines for risk management in medical devices. The risk management process aligns with ISO 14971, covering hazardous situations, risk control, verification, and change management. Risk management is integral to all processes in SaMD licensing.
Achieving compliance with global standards like ISO 13485 and IEC 62304 is critical for successful market entry. AmpleLogic’s Quality Management System (QMS) software enables seamless compliance tracking, automated risk management, and regulatory reporting for SaMD developers.
Importance of Regulatory Compliance
Adhering to these regulations is crucial not only for legal compliance but also for ensuring patient safety. Properly validated Software as a Medical Device can significantly enhance diagnostic accuracy and treatment efficacy while safeguarding patient data confidentiality.
Conclusion
The regulatory framework for Software as a Medical Device is complicated however, with the right understanding of the requirements, it is relatively easy to comply with. By adhering to the specified licensing procedures and implementing strict documentation practices, developers not only continue to thrive and develop but are also able to take on this road to the market. However, as technology continues to develop in the healthcare industry, all stakeholders will need to keep an eye out for any further changes in regulations.
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