ANVISA ESPR for Medical Devices in Brazil : RDC 848/2024
The Essential Safety and Performance Requirements (ESPR) serve as the backbone for ensuring that medical devices are not only effective...
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The Medical Devices Market in Singapore
Valued at US $2 Billion (est.)
Growing at a CAGR of 7.5%
60% of the World’s Medical Gloves
80% of Catheters Manufactured
95% Medical Devices Imported
The Health Sciences Authority is the primary medical regulating authority in Singapore (HSA). The Health Items Act, passed by the HSA in 2007, gives them the authority to enforce required product registration and control the supply, distribution, production, importation, and advertising of all healthcare products. The Singapore Medical Device Register (SMDR), which is accessible to the public on the HSA website, contains a list of registered medical devices.
Regulatory Authorities for Medical Devices
Class
Risk
Analysis
Surgical retractors, Tongue dips
Low risk
Class A
Low to Moderate risk
Class B
lung ventilator, bone fixation plate
Moderate to High risk
Class C
Highest risk
Class D
hypodermic needles, suction equipment
heart valves, implantable defibrillator
Classification of Medical Devices in Singapore
Process
Documents Required for Registration of Medical Devices in Singapore
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Common Submission Dossier Template (CSDT)
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Executive Summary
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Device Description
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Pre-Clinical Studies
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Clinical Evaluation
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Device Labelling
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Instructions for Use
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Risk Analysis
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Proof of Quality Management System (QMS)
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Manufacturing Information
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Essential Principle Checklist
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Existing Regulatory Approvals or Market Authorizations
Medical Devices Registration Services in Singapore
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Marketing Authorization Holder (MAH) Services
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• Gap Analysis
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Regulatory Intelligence and Strategy
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HSA Consultation and Meeting
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Technical File Preparation and Submission Quality Management System Implementation
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Audit Support
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Quality Training
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Response to HSA Queries
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Clinical Evaluation and Post Marketing Evaluation
Appoint a Local Representative
HSA Consultation
Device Classification
Device Conformity Assessment
QMS Conformity Assessment
Submit Application
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Services Offered
Market Size & Landscape Analysis
KOL Analysis
Price Sensitivity Analysis
Distributor Search and Licensing
Market Access
Marketing Authorization Holder
Post Market Maintenance
Post Market Surveillance Query Responses
Authorized Representative
Regulatory Intelligence & Strategy, Gap Analysis, Remediation and Submission
Regulatory Affairs
QMS Implementation
ISO 13845 Consulting, 21 CFR
820, SOP Development, Audits
Quality Management
Clinical evaluation reports (MEDDEV 2.7.1)
Clinical investigation protocols and reports
Medical Writing & Medical Review
Clinical Services
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