Medical Device Registration in Singapore

IVDs are devices used to examine human samples (e.g., blood, urine) to provide information for diagnostic, screening, or compatibility purposes. Risk classification for IVDs considers:

• Intended purpose
• Expertise of the user (layperson or professional)
• Impact on patient management
• Impact on public health

2. Device Registration

HSA offers three main evaluation routes, selected based on the device's risk class, regulatory history, and market performance.

a) Immediate Registration Route

This is the fastest option available to Class B devices and standalone Class C medical mobile apps that have been:

• Approved by at least one reference regulatory agency
• Marketed for ≥3 years without safety concerns
• Free of prior rejections.

If eligible, the device is registered almost immediately upon submission via HSA's MEDICS portal. Supporting documentation must still be complete and accurate, as post-registration audits may apply.

b) Abridged Evaluation Route

This route applies to Class B, C, and D devices approved by at least one reference agency but do not meet the full criteria for the immediate route. HSA performs a focused evaluation to ensure the device is substantially equivalent in terms of design, intended use, and performance. Review timelines range from 100 to 220 working days, depending on class.

c) Full Evaluation Route

Required for novel devices, those with no reference approvals, or any significant differences in design or intended use. This route involves a comprehensive assessment of technical documentation, including clinical data (for Class C/D), software validation, and risk analysis. Timelines range from 160 to 310 working days.

Note: Class A medical devices are considered low-risk and are exempt from product registration in Singapore. However, they must still be listed on HSA's MEDICS system by a licensed dealer (importer, manufacturer, or wholesaler). Listing is free and immediate, with no evaluation or waiting time. Dealers are still required to maintain distribution and complaint records, report adverse events (AEs), and inform HSA of any Field Safety Corrective Actions (FSCAs).

Across all classes, applications are first screened for completeness and route eligibility. Evaluation fees apply (except for Class A listings), and stop-clock periods are used when HSA requests additional information. Once approved, the device is listed on the SMDR, allowing legal supply in Singapore.

3. Priority Review Scheme (PRS)

The Priority Review Scheme is a fast-track process for certain medical devices, designed to expedite their approval when specific conditions are met. This scheme is applicable to devices with high clinical significance, such as those used in critical care, or devices that can significantly improve patient outcomes.

Eligibility Criteria for Priority Review:

• Class B, C, or D devices may qualify if they demonstrate significant clinical benefits, or if they meet specific health needs in Singapore.
• Devices with prior regulatory approval in two or more recognized reference countries (e.g., USA, EU) may also be eligible for priority review.
• Certain high-risk Class D devices, such as implantables, may be considered for expedited review if they have a clean safety record.

4. Target Turn-Around for Registration (in working days)

Turnaround Time (TAT) refers to the period it takes for HSA to process and approve a medical device registration after submission. It varies depending on the class of the device and the evaluation route selected. It does not include the time to respond to any clarifications from the Health Sciences Authority during the review phase.

5. Annual Retention Fee

After a device is registered, there is an Annual Retention Fee that must be paid to maintain the device's registration status on the Singapore Medical Device Register (SMDR).

• Class B Devices: SGD 500 per year
• Class C Devices: SGD 1,000 per year
• Class D Devices: SGD 2,000 per year

The Annual Retention Fee is due at the start of each year, and failure to pay it may result in the de-listing of the device from the SMDR.