Medical Device Regulatory Services in Singapore

Get expert help with medical device approvals, licensing, and regulatory compliance in Singapore. Trusted by global MedTech brands.

Medtech

Medical Devices Compliance Services in Singapore

Getting your medical device approved in Singapore means working closely with the HSA—and that process can be demanding. At Artixio, we help you handle the paperwork, timelines, and compliance steps so you can focus on getting your product to market faster.

The Health Sciences Authority (HSA) manages all medical device regulations in Singapore, from import and manufacture to supply and export. We work alongside your team to make sure everything meets their standards—without unnecessary delays.

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Key Regulations for Medical Devices in Singapore

Health Products Act (HPA)

Health Products (Medical Devices) Regulations 2010.

GN-15: Guidance on Medical Device Product Registration

GL-06: Medical Devices Product Classification Guide

GN-17: Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN CSDT

GN-23-R2 Guidance on Labelling for Medical Devices (2022 Sep) PUB292 KB

Classification of Medical devices

In Singapore, devices are classified to Class A, B, C and D depending on their risk level. Class A devices have low risk to patients, Class B devices are low to moderate risk, Class C devices are moderate to high risk while Class D devices are high risk, complex devices.

Process for Registration of Medical Devices in Singapore

Required Documents for Medical Device Registration in Singapore

Executive Summary
Device Description
Design Verification & Validation
Clinical Evidence
Device Labelling
Risk Analysis
Manufacturer Information

Artixio’s Medical Devices Registration Services in Singapore

Our Regulatory and Market Access experts based in Singapore, coupled with the Global Regulatory Projects team, have helped over a hundred pharmaceutical, medical devices, diagnostics, cosmetics, nutraceuticals, supplements, and veterinary products successfully register and maintain compliance in Singapore. Combined with Artixio’s intelligence-based services platform, Dvarka, innovators and manufacturers from around the world have benefited by seamlessly managing the regulatory strategy across the product development and commercialization value chain.

For Medical Devices, from strategic planning and registration to post-market compliance, Artixio provides high-quality regulatory affairs services to support your business needs.

Why Artixio For Medical device Consultation In Singapore?

FAQs

When is a Change Notification (CN) required?

An approval from HSA is required prior to implementing the following changes:

Technical changes to Class C and D medical devices.
Review changes for Class B medical devices.
Administrative changes that affect the Singapore Medical Device Register (SMDR) listing information.
Notification changes

What are the types of medical device dealer's license issued by HSA?

The different types of licenses issued by HSA include the manufacturer license, importer license and wholesaler’s license. The dealer’s license can be applied using MEDICS

What is Special access route of Medical Devices registration in Singapore?

Special access route is a pathway used to enable qualified practitioners to access unregistered medical devices for the patients to meet special clinical needs in the course of their treatment.

What is Priority Review Scheme?

The Priority Review Scheme provides the possibility for faster device registration and entry into the market for medical devices that are filed through full evaluation pathway.