Regulatory Guidelines for Software Medical Devices including Machine Learning-Enabled Medical Devices - A Life Cycle Approach - Revision 4

Oct 1, 2026

Guidelines define regulatory requirements for software medical devices, including machine learning-enabled medical devices, across the total product life cycle. The document sets expectations for quality management systems, pre-market product registration, labeling, software versioning and traceability, design verification and validation, clinical evaluation, risk management, and cybersecurity. It also covers manufacturer and distributor activity controls, change notifications, post-market management such as FSCA and adverse events, and additional MLMD considerations including continuous learning and monitoring, with a change management program.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages42

Reading Time1 h 46 min

AccessFree to download

INTRODUCTION

Objective

Intended Audience

Scope

QUALITY MANAGEMENT SYSTEM (QMS) FOR SOFTWARE MEDICAL DEVICES

PRE-MARKET PRODUCT REGISTRATION REQUIREMENTS

Essential Principles for Safety and Performance of Medical Devices

Labelling Requirements

Software Versioning and Traceability

Design Verification & Validation

Clinical Evaluation

Risk Management

Cybersecurity

SOFTWARE MANUFACTURERS AND DISTRIBUTORS: ACTIVITY CONTROLS

CHANGES TO A REGISTERED SOFTWARE: CHANGE NOTIFICATION

POST-MARKET MANAGEMENT OF SOFTWARE MEDICAL DEVICES

Field Safety Corrective Actions (FSCA)

Adverse Events

SOFTWARE WITH MULTIPLE FUNCTIONS

CYBERSECURITY

Importance of Cybersecurity

Cybersecurity Considerations

MACHINE LEARNING-ENABLED MEDICAL DEVICES

Regulatory Requirements for MLMD

Additional Considerations for MLMD with Continuous Learning Capabilities

Post-market Monitoring of MLMD

Changes to Registered MLMD

Change Management Program (CMP)

REFERENCES

December 2025 Regulatory Guidelines for Software Medical Devices including Machine Learning-Enabled Medical Devices – A Life Cycle Approach Revision 4 CONTENTS 1. INTRODUCTION................................................................................................. 4 1.1 Objective ............................................................................................................... 4 1.2 Intended Audience................................................................................................. 4 1.3 Scope .................................................................................................................... 4 1.4 Definitions.............................................................................................................. 6 2. QUALITY MANAGEMENT SYSTEM (QMS) FOR SOFTWARE MEDICAL DEVICES ................................................................................................................... 8 3. PRE-MARKET PRODUCT REGISTRATION REQUIREMENTS ...................... 10 3.1 Essential Principles for Safety and Performance of Medical Devices ................... 10 3.2 Labelling Requirements ....................................................................................... 12 3.3 Software Versioning and Traceability................................................................... 12 3.4 Design Verification & Validation ........................................................................... 13 3.5 Clinical Evaluation ............................................................................................... 14 3.6 Risk Management................................................................................................ 17 3.7 Cybersecurity....................................................................................................... 17 4. SOFTWARE MANUFACTURERS AND DISTRIBUTORS: ACTIVITY CONTROLS ............................................................................................................. 19 5. CHANGES TO A REGISTERED SOFTWARE: CHANGE NOTIFICATION ...... 20 6. POST-MARKET MANAGEMENT OF SOFTWARE MEDICAL DEVICES ......... 23 6.1 Field Safety Corrective Actions (FSCA) ............................................................... 23 6.2 Adverse Events ................................................................................................... 25 7. SOFTWARE WITH MULTIPLE FUNCTIONS ................................................... 25 8. CYBERSECURITY............................................................................................ 26 8.1 Importance of Cybersecurity ................................................................................ 26 8.2 Cybersecurity Considerations .............................................................................. 26 8.2.1 Secure Device Design ................................................................................. 27 8.2.2 Cyber Risk Management.............................................................................. 28 8.2.3 Verification and Validation............................................................................ 29 8.2.4 Establishment of a post market management plan....................................... 30 8.2.5 Addressing Risks for Medical Device Operating System Reaching End of Support 31 8.3 Patient Confidentiality and Privacy and Other Regulations .................................. 32 9. MACHINE LEARNING-ENABLED MEDICAL DEVICES ................................... 32 9.1 Regulatory Requirements for MLMD.................................................................... 33 9.2 Additional Considerations for MLMD with Continuous Learning Capabilities........ 35 9.3 Post-market Monitoring of MLMD ........................................................................ 37 9.4 Changes to Registered MLMD........................................................................

FAQs

What is the purpose of these regulatory guidelines for software medical devices?

The guidelines clarify regulatory requirements for software medical devices, including those with machine learning features, throughout the product life cycle, from development to post-market obligations for products supplied in Singapore.

Which areas are covered by the quality management and pre-market registration requirements?

They cover quality management systems, essential safety and performance principles, labeling, software versioning and traceability, design verification and validation, clinical evaluation, risk management, and cybersecurity.

How do the guidelines address updates after a product is registered and how are post-market activities managed?

They include change notification requirements for registered software and post-market management covering field safety corrective actions (FSCA) and adverse events, alongside MLMD-specific change and monitoring considerations.

Oct 1, 2026

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