The new article describes the key steps and requirements associated with pre-market product registration in the context of software medical devices intended to be marketed and used in the country.
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The Health Sciences Authority (HSA), Singapore’s regulatory agency in healthcare products, has published a guidance document dedicated to software medical devices in the context of a life cycle approach.
The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be considered by medical device manufacturers (software developers) to ensure compliance to it.
At the same time, the authority reserves the right to change the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Pre-Market Product Registration for Software Medical Devices: Overview
To be allowed for marketing and use in Singapore, software medical devices should comply with the relevant registration requirements, ensuring that these devices meet the highest safety, performance, and cybersecurity standards.
The guidance document issued by the HSA outlines the essential steps and documentation required for the successful registration of software medical devices, focusing on the ASEAN Common Submission Dossier Template (CSDT) and the International Medical Device Regulators Forum (IMDRF) guidelines.
Essential Framework for Pre-Market Registration
First of all, the document provides an overview of the existing legal framework addressing the matters associated with pre-market registration of software medical devices, highlighting the key aspects to be taken into consideration by medical device manufacturers (software developers) to ensure their products are fully compliant with the regulatory requirements they are subject to and thus could be marketed in the country.
ASEAN CSDT and IMDRF Integration
According to the guidance, manufacturers aiming to register medical devices must prepare their product registration application per the ASEAN CSDT.
This template is harmonized with the Non-In Vitro Diagnostic Medical Device Market Authorization Table of Contents (nIVD MA ToC) issued by the IMDRF, providing a streamlined approach for documentation and submission.
The corresponding sections between the IMDRF ToC and CSDT are detailed, facilitating manufacturers in preparing their dossiers effectively.
Guidance Documents for Registration
The Health Sciences Authority also provides comprehensive guidance through documents GN17 and GN18, which offer insights into preparing product registration submissions for general and In Vitro Diagnostic (IVD) medical devices.
These documents are vital for understanding the specific requirements for software medical devices within the CSDT dossier, covering aspects from essential safety principles to cybersecurity.
Key Sections of the CSDT Dossier
The document further elaborates on the content of the CSDT Dossier and its essential elements, emphasising its importance for preparing marketing submissions.
- Essential Principles for Safety and Performance: All medical devices must adhere to fundamental design and manufacturing requirements to ensure their safety and efficacy throughout their lifecycle. For software medical devices, this includes a checklist of essential principles that cater to their unique nature, with documentation provided for any non-applicable requirements.
- Labelling Requirements: Labelling is crucial for identifying devices, communicating safety and performance information, and ensuring traceability. The relevant section outlines the minimum information that must be included on device labels or software interfaces, tailored to whether the software is supplied in physical form or digitally.
When it comes to labelling, a party responsible for a medical device should ensure all the vital information necessary for safe and proper use is duly communicated to its potential users. - Software Versioning and Traceability: According to the guidance, effective software versioning and a traceability system are mandatory for post-market monitoring and safety corrective actions. This includes clear documentation of the registered software version and subsequent versions, highlighting all changes and iterations.
- Design Verification & Validation: Software medical devices must undergo rigorous verification and validation to ensure accuracy, reliability, and safety.
This involves analytical validation and generating objective evidence that the software meets all specified safety and performance requirements. - Clinical Evaluation: Clinical evaluation affirms the software’s safety and effectiveness in its intended clinical environment. This process establishes a valid clinical association between the software’s output and the specified clinical condition, supported by various clinical evidence.
- Risk Management: Risk management addresses all foreseeable risks associated with the software, assessing and mitigating them to acceptable levels. This systematic approach is crucial for both the software and, if applicable, the embedded hardware components of the medical device.
- Cybersecurity: Given the increasing interconnectivity of medical devices, cybersecurity becomes paramount. Manufacturers must submit comprehensive plans for cybersecurity control measures, vulnerability assessments, and ongoing surveillance mechanisms to mitigate potential threats effectively.
Conclusion
The registration of software medical devices requires rigorous preparation and adherence to both ASEAN and international guidelines. By following the detailed requirements outlined in the CSDT dossier and aligning with IMDRF standards, manufacturers can navigate the pre-market registration process effectively. This ensures that software medical devices entering the market are safe, effective, and secure, ultimately contributing to advancing healthcare technology and patient care.
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