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Medical Devices Regulatory Services in Singapore
Your Partner for End-to-End Regulatory Affairs Services in Singapore, From Strategy to Registration and Post Approval Maintenance
Artixio offers extensive regulatory services to global manufacturers, facilitating smooth navigation of Singapore’s HSA regulations.
Health Sciences Authority (HSA) regulates the import, manufacture, export and supply of medical devices in Singapore to safeguard public health and safety.
Services
Regulatory Intelligence & Strategy
MDR Gap Assessment
Medical Device Regulatory Affairs
Quality Consulting
Technical and Medical Writing
Clinical, Performance Evaluation
Medical Device Registration / Certification
Authorized Agent / Legal Representation
Post Market Surveillance
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
Documents Required for Registration of Medical Devices 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?
Industry Recognized (CPHI Pharma Awards 2024) Tech-Enabled, Regulatory Intelligence driven Services
Ensuring compliance for 200+ Devices and Diagnostics Products Licenses
120+ Countries supported
Inhouse Regulatory Experts with 15-30+ Years of Experience
End to End Support from Product Conceptualization to Launch and Post Market Support
Wide Product Experience: Devices, Diagnostics, Combination Drugs, Software as Medical Devices (SaMD), Consumer Devices
Diverse Experience across Complex Therapeutic areas and Application Areas
ISO 9001:2015, Quality Driven Services Platform
Flexible Business Models – Project Based; Long Term FTE based
Customer Focused, Nimble Team
KPI based, continual process excellence
Represent your organization and device 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.
Regulatory Expertise Across
Multiple Countries
India
Vietnam
Mexico
Vietnam
United States
Brazil
Europe
Malaysia
Taiwan
China
Thailand
Philippines
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