Special Access Route: Lawful Import and Use of Unregistered Devices

1. Key takeaways

Singapore provides a Special Access Route, or SAR, for medical devices that are not registered, and HSA approval must be obtained before the device is imported or supplied. The main routes are import for re-export; non-clinical use such as trade shows, exhibitions, performance testing, research and development, and professional training; import or supply at the request of a qualified practitioner for a specific patient; and import or supply by a licensed healthcare institution for its own patients. The official fees are SGD 280 for re-export, SGD 280 for non-clinical use, SGD 168 for a qualified practitioner and SGD 390 for a licensed healthcare institution, the last with a review period of 14 working days.

• Prior approval, not notification. HSA states that the device may only be imported after the application is approved.
• Four routes, four purposes. Re-export, non-clinical use, qualified practitioner and licensed healthcare institution each have their own scope and fee.
• Non-clinical use is narrow. Devices imported under that route may not be used on patients or supplied onward.
• SAR does not suspend other duties. Part VIII obligations, including reporting product problems and adverse events, continue to apply.
• Custom-made devices are a separate track. They are not registered, but the dealer must keep HSA’s list of custom-made devices updated.
• SAR is an exception, not a shortcut. It addresses defined situations outside registration and is not a substitute for it.

2. Legal basis

Section 15 of the Health Products Act 2007 prohibits the supply of unregistered health products unless otherwise provided, and the Health Products (Medical Devices) Regulations 2010 set out the exceptions through which an unregistered device may be imported or supplied. The SAR is the administrative route through which those exceptions are approved in advance. HSA’s guidance is unambiguous on sequencing: the medical device shall only be imported after the application is approved. The same framework carries post-market obligations, and devices regulated under other legislation, such as those subject to the Radiation Protection Act and requiring a licence from the Radiation Protection and Nuclear Science Department of the National Environment Agency, need that separate authorisation as well.

The four routes are compared below. The scope of each is defined by purpose, not by product, which is why the same device can travel under different routes at different times and why the intended use at the point of import determines the application.

3. Expert insights

SAR is a prior approval regime, not a post-hoc filing. HSA’s guidance states that the medical device shall only be imported after the application is approved. Importing first and applying afterwards is unauthorised supply of an unregistered device, whatever the intention behind it. This matters most in organisations where the shipping schedule is set by the commercial team and the regulatory team is brought in at the last moment. The approval has to precede the shipment, and the shipment plan should be built backwards from the approval date rather than the other way around.

The non-clinical route is the correct answer for exhibitions and demonstrations. Companies that tour Southeast Asia with demonstration units often assume that carrying a sample through customs is unproblematic. Under the rules, importing an unregistered device for trade shows, exhibitions, performance testing, research and development or professional training goes through the non-clinical use SAR at SGD 280, and the device may not be used on patients or supplied. The scope is what makes the route useful: it legitimises activity that is genuinely non-clinical, while removing any argument that a demonstration unit can be left behind with a prospective customer.

SAR does not waive other obligations. According to HSA, the approval holder still has to meet the obligations under Part VIII of the Health Products Act 2007, including reporting product problems and adverse events related to the device. That means a vigilance process has to be in place even for a device that is not registered in Singapore. Where the device is also regulated under other legislation, such as devices within the scope of the Radiation Protection Act that require a licence from the Radiation Protection and Nuclear Science Department of the National Environment Agency, the separate authorisation must be obtained as well. Two regulators mean two applications, not one.

Custom-made devices are an independent track and should not be confused with SAR. HSA states that custom-made devices which meet the criteria do not require registration, but the dealer must update HSA’s list of custom-made devices. This is a standing arrangement rather than a per-shipment approval, which is the opposite of the SAR model. Companies working on 3D-printed personalised implants or custom orthoses should look at this track closely, and HSA also publishes dedicated guidance and an FAQ on the regulation of 3D-printed medical devices. Choosing between a standing listing obligation and a case-by-case approval is a structural decision, not an administrative preference.

SAR does not replace registration, and treating it as a shortcut creates compliance risk. Where a product is intended for routine commercial supply, the correct route is registration. The SAR exists to resolve specific situations that registration does not cover: goods passing through Singapore for re-export, equipment used at an exhibition, a device needed for one named patient, or supply within a licensed institution for its own patients. A company that uses SAR repeatedly to supply the market without registering is not exploiting a flexibility in the system; it is accumulating exposure across every shipment, because each approval is tied to a defined situation that does not include general distribution.

4. Practical recommendations

• Classify the situation before choosing the route. Decide between re-export, non-clinical use, qualified practitioner and healthcare institution on the basis of purpose.
• Import only after approval. Never ship first and apply afterwards, however firm the commercial deadline.
• Apply early for exhibition and demonstration units. Non-clinical use needs front-loaded planning because the approval must precede shipment.
• Maintain vigilance under SAR. Keep a reporting process for product problems and adverse events even without registration.
• Check other regulators. Screen for legislation such as the Radiation Protection Act and obtain any separate licence before import.
• Use the custom-made track where it fits. Confirm the criteria and keep HSA’s list of custom-made devices current.

5. Verification checklist

• □ The applicable SAR route has been identified
• □ Approval will be obtained before import, not after
• □ The non-clinical route has been confirmed as not involving patient use or supply
• □ Any additional legislation, such as radiation protection, has been checked
• □ Vigilance obligations under SAR are planned and assigned
• □ Custom-made devices have been assessed for the separate track and list update obligation

Regulatory information verified as of 26 October 2026. Source tiers: secondary (HSA special access guidance, HSA custom-made devices page, HSA fees page); primary (Health Products Act 2007, section 15 and Part VIII).

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Singapore. Our team prepares dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with HSA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com