What is a Medical Device?
The definition of a medical device under Singapore's Health Products Act, including the intended purpose test, examples, and borderline products.
What is Not a Medical Device?
Products that fall outside the definition of a medical device under Singapore's Health Products Act, and how HSA treats common borderline cases.
Regulatory Framework Overview
An overview of Singapore's medical device regulatory framework — the Health Products Act, HP(MD) Regulations 2010, HSA's role, and how the framework is structured.
Key Roles and Responsibilities
The key roles in Singapore's medical device regulatory framework — manufacturer, importer, wholesaler, and registrant — and how their obligations differ.
The Dual Obligation Model
Singapore requires both product registration and a dealer's licence before medical devices can be lawfully supplied. This page explains how the two obligations interact.
Class A — Exemption and Notification
Class A medical devices in Singapore are exempt from product registration, but a product notification must still be submitted via SHARE. This page explains what Class A means and what is still required.
Lifecycle of a Medical Device in Singapore
An end-to-end overview of the medical device regulatory lifecycle in Singapore — from classification through registration and licensing to post-market compliance.
Glossary of Key Terms
Plain English definitions of the key regulatory terms used in Singapore's medical device framework — HSA, SHARE, SMDR, FSCA, GDP, QMS, and more.