Regulatory Affairs Services for MedTech in Singapore

Launch and maintain your medical devices in Singapore with confidence. Artixio offers end-to-end regulatory affairs services that your medical device meets the strict requirements of the Health Sciences Authority (HSA). From product registration to post-market compliance, we help streamline your path to approval.

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Medical Device Regulatory Affairs Consultant in Singapore

Introducing a medical device in Singapore involves understanding a detailed set of regulations that prioritize safety and quality. The Health Sciences Authority (HSA) sets clear standards to ensure products meet strict requirements before reaching the market.

At Artixio, we provide medical device regulatory affairs consulting services and guide you through each stage, from classification to approval, making sure you stay aligned with local regulations. Our team handles the paperwork, coordinates with the necessary authorities, and helps ensure your product stays compliant at every step.

MedTech Regulatory Authorities in Singapore

Regulatory Body	Role & Function
Health Sciences Authority (HSA)	Oversees the safety, efficacy, and quality of medical devices, including registration, classification, and compliance monitoring.
Ministry of Health (MOH)	Works with HSA to establish and enforce health-related regulations, including MedTech.
Singapore Accreditation Council (SAC)	Accredits testing and calibration laboratories for medical devices.
Singapore Standards Council	Develops national standards for medical devices to ensure their safety and performance in the market.

Medical Device Regulatory Affairs Process in Singapore

Product Classification

Identify your medical device’s classification (Class A, B, C, D) based on risk level.

Pre-market Approval

Local Representation

Appoint a local Authorized Representative (AR) in Singapore if you’re a foreign manufacturer.

Labeling and Documentation

Ensure product labeling complies with HSA guidelines and includes necessary safety information, including instructions for use.

Post-Market Surveillance

After market approval, ongoing surveillance is required, including adverse event reporting and regular safety updates.

Renewals and Maintenance

Medical device registrations in Singapore need periodic renewals and updates to stay in compliance with changing regulations.

Why Choose Artixio for Medical Device Regulatory Affairs in Singapore?

FAQs

Does my medical device need clinical trials for approval in Singapore?

Clinical trials may be necessary depending on the classification of your device and its intended use. Artixio will guide you on the need for clinical data and trial support.

Can Artixio assist with post-market monitoring and compliance?

Yes, we provide ongoing post-market surveillance services to ensure your device maintains compliance with HSA regulations even after market approval.

How do I ensure my product’s labeling meets Singapore’s regulatory standards?

Artixio provides expertise in medical device labeling, ensuring all regulatory requirements such as user instructions, warnings, and compliance information are met.