On 5 November 2025, the 保健科学局（HSA） of Singapore released new guidance documents outlining regulatory requirements for medical device registration, compliance, grouping criteria, and submission processes. The update aims to streamline regulatory pathways while reinforcing safety and performance expectations for medical devices supplied in Singapore. The guidance applies to manufacturers, importers, wholesalers, and other stakeholders operating across the medical device supply chain.
Overview of the Updated Guidance
The new publications clarify the criteria for permissible and non-permissible variants of IVD (In Vitro Diagnostic) analysers の下で FAMILY grouping framework. Variants that alter diagnostic functions require separate listings, while permissible variants can be grouped more efficiently under existing rules.
The guidance also introduces detailed expectations for machine learning-enabled medical devices, requiring documentation of model training, validation, potential vulnerabilities, and integration into clinical workflows.
のために connected medical devices, HSA mandates the submission of サイバーセキュリティ evidence along with plans for ongoing threat detection and management.
Additionally, the update reinforces the need for ISO 13485 or SS 620 (GDPMDS – Good Distribution Practice for Medical Devices) certification across the supply chain, except for Class A devices that meet specific declaration requirements. Stakeholders must also ensure timely renewal of dealer licenses via the SHARE system (Singapore Health Product Access and Regulatory E-System), with auto-renewal available for GIRO users, and must update Class A medical device notifications prior to import or supply.
これがなぜ重要なのか
The updated guidance provides greater clarity on device grouping, AI-enabled device documentation, cybersecurity safeguards, and supply chain quality certifications. These requirements support regulatory consistency, help streamline product registration, and ensure continued alignment with Singapore’s safety and performance standards without introducing unnecessary administrative burden.
このアップデートをレビューすべき人
This publication is relevant for Regulatory Affairs, Quality Assurance, AI and software development teams, manufacturers, importers, そして wholesalers dealing with medical devices in Singapore, especially those managing IVD analysers, connected devices, or machine learning-enabled technologies.
次のステップ
Stakeholders should review the updated HSA guidance to confirm that product classifications align with FAMILY grouping criteria. Regulatory teams should assess documentation for machine learning-enabled devices and connected device cybersecurity evidence, verify ISO 13485 or SS 620 certifications across the supply chain, and ensure Class A notifications are updated before import or supply. As organizations refine compliance strategies, RegASK supports proactive monitoring and alignment with evolving Singapore HSA expectations.
RegASKはリーディング エージェント型AI規制インテリジェンスおよびワークフローオーケストレーションプラットフォーム that empowers global organizations in highly regulated sectors, including consumer products and life sciences, to proactively navigate complex regulatory landscapes. By combining advanced Agentic AI with experts in the loop, RegASK delivers timely predictive actionable insights and end-to-end automation, streamlining compliance processes, mitigating risks, and accelerating market access across more than 157 countries.
よくある質問
What changes were introduced for IVD analysers in the new HSA guidance?
The update clarifies that IVD analyser variants affecting diagnostic function require separate listings, while permissible variants may be grouped under the FAMILY criteria.
What are the documentation requirements for machine learning-enabled medical devices?
Manufacturers must provide details on model training, validation, vulnerabilities, and how the model integrates into the intended clinical workflow.
Are there new certification requirements for medical device supply chain stakeholders?
Yes. ISO 13485 or SS 620 (GDPMDS) certification is required across the supply chain, except for Class A devices that meet specific declaration conditions.
How can RegASK support companies responding to HSA’s updated guidance?
RegASK helps organizations track evolving HSA requirements and assess compliance readiness using predictive regulatory intelligence.
