Health Products Act (HPA) and the Health Products (MD) Regulations 2010
HSA Medical Device Regulations in Singapore
In Singapore, the Health Sciences Authority (HSA) ensures the safety, quality, and compliance of medical devices and in vitro diagnostic devices (IVDs). These products are regulated under the Health Products Act (HPA) and the Health Products (Medical Devices) Regulations 2010.
Key Responsibilities of the HSA:
- Guaranteeing medical device safety through rigorous regulatory standards.
- Overseeing quality control to ensure products meet strict performance benchmarks.
- Managing vigilance systems to monitor and address risks post-market.
Qserve specializes in guiding medical device and IVD manufacturers through the complexities of the HSA Medical Device Regulations.
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Medical Device Classification in Singapore
HSA Medical Device Regulations in Singapore
All medical devices in Singapore must be registered in the Medical Device Information Communication System (MEDICS) and approved by the Health Sciences Authority (HSA) before being supplied. However, low-risk Class A devices are exempt from product registration.
The registration and documentation requirements depend on the device's risk classification and the type of evaluation route. Singapore’s regulatory framework offers flexibility by recognizing overseas regulatory approvals from trusted agencies in countries such as:
- Australia
- Canada
- Japan
- United States
- European Union
These agencies, known as Overseas Reference Regulatory Agencies, simplify the registration process for devices already approved in these regions.
Singapore’s regulatory system aligns with the countries participating in the Medical Device Single Audit Program (MDSAP), making it useful to include Singapore in your market access strategy. Incorporating an MDSAP-compliant approach not only streamlines Singapore registration but also supports global market entry.
Depending on your existing overseas approvals, data, and evidence, manufacturers can select the most suitable approach to meet the HSA Medical Device Regulations. This tailored strategy ensures compliance while minimizing lead time to market.
Registration routes in Singapore
Submission pathways
Singapore offers four distinct evaluation routes for registering medical devices, depending on the device's risk classification, approval status, and market history. These routes are designed to provide flexibility while ensuring compliance with the Health Sciences Authority (HSA) regulations.
- Full Route (With or Without Priority)
The Full Route is for devices not yet approved by the Overseas Reference Regulatory Agencies. This pathway involves a comprehensive review by the HSA to ensure the device meets Singapore’s safety and performance standards.
- Abridged Route
The Abridged Route applies to devices approved by at least one Overseas Reference Regulatory Agency, regardless of risk classification. This pathway reduces the time and complexity of the approval process by leveraging prior regulatory reviews.
- Expedited Route
The Expedited Route is a fast-track approach for devices based on their overseas approvals and risk class. While overseas approval is a factor, this route also evaluates the device's risk profile to determine eligibility for accelerated review.
- Immediate Route
The Immediate Route is reserved for specific cases, depending on:
- The device’s risk classification.
- The number of years the device has been on the market without any safety issues.
This route provides a streamlined process for well-established devices with proven safety records.
Find comprehensive details about the evaluation routes in the blog Things You Need To Know about Medical Device Registration in Singapore.