Medical Device Registration and Approval Process in Singapore

To sell, import, or distribute a medical device in Singapore, you must first register it with the Health Sciences Authority (HSA). The HSA administers this process under the Health Products Act and the Health Products (Medical Devices) Regulations 2010. 

These laws define the safety, quality, and performance standards that all medical devices must meet before they can be sold. Without registration, your device has no viable path to market. Distributors, hospitals, and clinics are only permitted to source from registered suppliers.

In this guide, we break down the medical device registration process in Singapore. We will cover the key requirements, device classifications, and what to expect at each stage of your application.

What is Considered a Medical Device in Singapore?

The Health Products Act defines a medical device as any instrument, apparatus, software, or material intended for use on humans to diagnose, prevent, monitor, treat, or alleviate disease or injury. The Act also outlines different medical device classifications depending on its risk factor (see details below). 

Products used purely for lifestyle or well-being are not considered medical devices. This includes:

• Body toning equipment and massagers.
• Magnetic accessories.
• Wellness-based telehealth apps (provided they include a label stating they are not for medical use).

Key Pre-Requisites Before Medical Device Registration in Singapore

You must prepare and meet specific requirements before registering your medical device with the HSA. This includes local representation, the correct licenses, and a confirmed understanding of how your device is classified. 

1. Appoint a Local Representative (Registrant)

The HSA does not accept applications directly from foreign manufacturers. You’ll have to appoint a Singapore-based authorized Representative as a Registrant, to act as your legal presence in the market. You have two options to meet this requirement:

• Set Up a Local Subsidiary: Register your own Singapore company with ACRA to act as the Registrant. This gives you the highest level of direct control but requires more upfront capital and stretches your overall timeline by a few months.
• Appoint an Independent Registrant: Engage a specialized firm such as Emerhub to hold the license on your behalf. This is the fastest route to enter the market without the overhead of starting a local subsidiary.

The Registrant holds the product license and is legally responsible for all ongoing compliance and communication with HSA. Emerhub can serve as your Registrant in Singapore, managing the entire registration process on your behalf.

2. Obtain the HSA Dealer’s License

Any entity handling medical devices in Singapore must hold a valid HSA dealer’s license. This applies to all device classes, including Class A devices, which are exempt from product registration but not from licensing. There are three types of licenses:

License Type	Feature	Primary Requirement
Manufacturer’s License	For fabricating, processing, or re-labelling devices in Singapore.	ISO 13485 Certification
Importer’s License	For legally bringing medical devices into Singapore through customs.	GDPMDS or ISO 13485
Wholesaler’s License	For supplying devices to local hospitals, clinics, or for export.	GDPMDS or ISO 13485

What if you plan to manufacture, import, and distribute? Your licenses must reflect every activity you intend to carry out. If your Singapore entity will both import and wholesale, you need separate licenses for each. All applications are submitted via HSA’s SHARE portal.

3. Determine Your Medical Device Classification

Singapore uses a four-tier risk classification system aligned with the ASEAN Medical Device Directive (AMDD). Your device’s class determines your registration pathway, documentation requirements, and approval timeline.

Risk Class	Risk Level	Examples
Class A	Low	Examination gloves, hospital beds, bandages
Class B	Low to Moderate	Contact lenses, dental filling materials, software
Class C	Moderate to High	Ventilators, orthopaedic implants, in vitro diagnostics
Class D	Highest	Heart valves, pacemakers, implantable defibrillators

Class A devices are exempt from product registration but require a product notification through the SHARE system. Class B, C, and D devices must be registered with the HSA before they can be sold.

Compliance Tip: Misidentifying your device’s risk class can lead to application rejections, additional fees, and delays to your launch timeline. Emerhub’s local advisors can verify your specific product classification and registration route.

4. Compile Your Registration Documents

To streamline the registration process, you should have all the necessary documents ready before you submit. Note that Singapore’s documentation standards may differ from your home market. Prior approval from a reference agency (see alternative pathway section below) reduces what HSA independently reviews. However, it does not replace Singapore-specific requirements.

You must submit the following in English along with your registration application:

• Device description and intended use: Design profile, materials, components, and clinical indications.
• Essential Principles checklist (GN-16): Self-declaration confirming how your device meets HSA’s safety and performance requirements.
• Risk management documentation (ISO 14971): Hazard analysis, control measures, and residual risk evaluation.
• QMS certificate: ISO 13485 is the standard. US FDA cGMP or Japan MHLW Ordinance No. 169 are also accepted.
• Pre-clinical data: Biocompatibility, sterilisation validation, and shelf-life studies
• Clinical evaluation report: Required for Class C and D; for Class B, depends on intended use.
• Labelling and IFU: Compliant with GN-23.
• Post-market surveillance plan: Complaint handling, adverse event reporting, and FSCA procedures.
• Reference agency approval documents: Required for abridged, expedited, and immediate routes.

For abridged or expedited routes, you can submit the pre-clinical and clinical sections as summaries, referencing prior assessments by the relevant reference agency. See the section below on alternative pathways.

Emerhub’s compliance team can help you prepare and verify all required documents to ensure accuracy and completeness before your HSA submission.

How to Register a Medical Device in Singapore

You can formally begin the registration process once you meet all the requirements above. Class A product notifications are processed immediately on submission. For Class B, C, and D devices, registration through the abridged route typically takes 3 to 6 months, while full evaluation can run from 6 to 15 months. 

Delays often stem from incomplete dossiers or outstanding Input Requests from HSA, which can push your timelines further.

Step 1: Preparation and Pre-Registration

Start by confirming that you meet all the key requirements outlined above. This includes appointing your Registrant, securing the appropriate dealer’s license, and verifying your device classification and evaluation route.

Classification determines the level of scrutiny your application faces, which CSDT sections apply, and how long the process will take. Emerhub can act as your licensed registrant, helping you confirm your product classifications and handling the entire registration process for you.

Step 2: Compile an ASEAN CSDT dossier (for Class B and Above)

For class A devices, you simply need to submit a product notification to the HSA via the SHARE portal. For Class B, C, and D devices, however, you must prepare a dossier based on the ASEAN Common Submission Dossier Template (CSDT). 

The CSDT is the standardized format HSA uses to assess your device’s safety, quality, and performance. If you have already prepared a CSDT for another ASEAN market, much of it can be adapted for Singapore. All submissions must comply with 2025 updates on GN-17 (general medical devices) or GN-18 (IVDs). The core components include:

• Device description: Engineering drawings, bill of materials, chemical compositions for patient-contacting parts, and mechanism of action.
• Essential Principles checklist: Cross-references each GN-16 requirement with the specific evidence in your dossier.
• Risk management report: Hazard identification, control measures, and residual risk evaluation per ISO 14971.
• Pre-clinical and clinical data: Full reports or summaries depending on your evaluation route.
• Post-market surveillance plan: Complaint handling procedures, adverse event reporting, and Field Safety Corrective Action (FSCA) protocols.

Emerhub can prepare your dossier and ensure full compliance with Singapore-specific labelling and intended use requirements.

Step 3: Submission via SHARE system

Your Registrant submits the completed application through HSA’s SHARE portal and pays the applicable fees upon submission. All fees are non-refundable, including misfilings or applications withdrawn after acceptance. 

HSA also allows grouping of similar devices under a single application. You can register devices within the same product family or system together, reducing both the number of filings and the overall cost.

HSA’s Priority Review Scheme (PRS) is also available for full evaluation submissions. It shortens standard review timelines by approximately 35% but comes with significantly higher fees (between S$4,420 – S$17,500) depending on your classification.

• PRS Route 1 applies to devices addressing unmet clinical needs in priority disease areas. This includes cancer, cardiovascular disease, diabetes, ophthalmic disease, and infectious disease.
• PRS Route 2 covers other full evaluation submissions that do not meet Route 1 criteria.

Step 4: Address HSA Input Requests (IR)

Once your application passes the completeness check, HSA moves it to technical evaluation. Reviewers assess your device specifications, risk analysis, clinical data summaries, and quality system documentation. Class C and D submissions face more intensive scrutiny given the level of patient exposure involved.

HSA may also issue an Input Request (IR) at any point during this phase. This is a formal request for additional information on specific areas of your dossier. Common inquiries revolve around clinical evidence gaps, sterilization validation, or detailed risk mitigations. 

As your licensed Registrant, Emerhub manages the review process on your behalf. We’ll respond to IRs accurately and on time, to keep your application on track.

Step 5: Receive Your Final Approval

Upon approval, your device is listed on the Singapore Medical Device Register (SMDR). You are now legally cleared to import, sell, and distribute your product in the Singapore market.

Medical Device registration does not expire. However, you must pay annual retention fees to keep the listing active. Post-approval, you must notify HSA of device changes under GN-21, report adverse events within defined timeframes, and file Field Safety Corrective Actions (FSCA) via OSCAR before initiating them.

Alternative Pathways to Register Your Medical Devices in Singapore

If your device already holds approval from a recognised reference market, you may qualify for a faster registration route into Singapore. HSA accepts prior assessments from five regulatory bodies as credible evidence: the US FDA, EU Notified Bodies, Health Canada, Australia’s TGA, and Japan’s PMDA.

There are three pathways available for devices with existing international approvals:

• Immediate Registration: For Class B devices with approval from two or more reference markets. The device is listed on the SMDR on the day of submission.
• Abridged Evaluation: For Class B, C, or D devices approved in at least one reference market. You can submit summarized pre-clinical and clinical data, referencing the prior assessment of the relevant authority.
• Expedited Evaluation: For Class B, C, or D devices approved in two or more reference markets, with at least one being an HSA-designated reference agency. HSA reviews only the sections most relevant to the device’s risk profile rather than conducting a full dossier evaluation.

Devices with no prior approval in any reference market undergo Full Evaluation, which requires complete technical documentation and the most comprehensive HSA review. Across all pathways, approvals must cover the same device and the same labelled intended use as what you are registering for Singapore.

Emerhub’s compliance experts can determine which pathway your device qualifies for and identify any documentation gaps before registration. We can also handle the registration process end-to-end and facilitate a smooth market entry into Singapore.

Planning to register a medical device in Singapore? Fill out the form below to discuss your plans with our local team. We’ll reach out to explore how we can support your needs.