Things you need to know about market access in Singapore

In Singapore, the Health Sciences Agency (HSA) regulates the import, manufacturing, export and supply of medical devices to safeguard public health safety. Medical devices are regulated in Singapore under the Health Products Act (HPA) and its Health Products (Medical Devices) Regulations 2010.

Singapore is an attractive market for medical device manufacturers due to its strategic location, trusted regulatory system, and strong healthcare infrastructure. The HSA offers various reliance pathways, speeding up approval for devices already cleared in other major markets. High healthcare spending, an aging population, and public-private demand fuel consistent growth. Its efficient MEDICS portal and regulatory clarity make it a low-barrier, high-value entry point for global MedTech companies.

Before launching a medical device in Singapore, it must first be registered with the (HSA). This is a critical step to ensure that all devices meet Singapore’s strict safety and quality standards before reaching patients. The HSA follows a structured regulatory approach designed to protect public health while supporting innovation.

The registration process involves three key steps:

1.        Classifying your device based on HSA’s risk-based classification system

2.        Obtaining a dealer’s license (commonly referred to as a Wholesaler’s or Importer’s License) to legally import, manufacture, or distribute medical devices.

3.        Registering the device through HSA’s MEDICS system, using the appropriate evaluation route depending on the device’s risk level and market history.

Classification

Before starting the actual submission preparation and submission, it is crucial to determine the correct risk classification of the medical device, according to the risk classification rules determined in the Health Products (Medical Devices) Regulations 2010, as the risk classification determines the eligible market access route options and the corresponding documentation requirements, timelines and costs.

In Singapore, there are four risk classes ranging from A (low risk) to D (high risk) as shown below.

·        Class A – Low Risk (e.g., bandages)

·        Class B – Low-Moderate Risk (e.g., suction pumps)

·        Class C – Moderate-High Risk (e.g., bone fixation plates)

·        Class D – High Risk (e.g., implantable pacemakers, heart valves)

For your reference, HSA has developed a risk classification tool that guides users in determining the appropriate risk class of a medical device by answering a structured series of questions.

Dealer License Registration

In Singapore, companies involved in the import, manufacture, or supply of medical devices are legally required to obtain a dealer’s license from the Health Sciences Authority (HSA). This requirement is outlined under the Health Products (Medical Devices) Regulations 2010. According to these regulations, a dealer is defined as any person or entity who manufactures, imports, or supplies medical devices. Supplying includes both wholesale distribution and commercial sales.

As stated in Regulation 4(1):

“No person shall manufacture, import or supply a medical device unless he is licensed as a dealer in relation to that device.”

 This means that any party intending to place a medical device on the Singaporean market must first obtain the appropriate dealer’s license for their activity, whether as a manufacturer, importer, or wholesaler. The application is submitted via HSA’s MEDICS online system, and license holders must comply with the Good Distribution Practice for Medical Devices (GDPMDS) standard or submit their Medical Device Singe Audit Program (MDSAP) or ISO 13485 certificate, to ensure quality and safety throughout the supply chain.

Device Registration

In Singapore, medical devices classified as Class B, C, or D must undergo product registration with the HSA before they can be marketed. To support efficient and risk-appropriate access, HSA offers several evaluation routes that vary based on the device's risk class, regulatory approvals from reference markets, and history of safe use.

1. Immediate Registration Route

Applicable to Class B devices, this route allows for immediate listing if the device:

·        Has been approved in at least one or two reference regulatory agency (e.g., US FDA, EU, TGA, Health Canada, PMDA)

·        Has a proven safety record with at least 3 years of marketing history in the reference regulatory agency countries

·        No rejection or withdrawal of the medical device from any of the reference regulatory agency countries due to quality, performance or safety issue

This is the fastest route, requiring minimal review

2. Abridged Evaluation Route

This route is open to Class B, C, and D devices with:

·        At least one approval from a reference agency

·        A summary technical dossier that meets HSA’s documentation requirements.

It offers a moderate review timeline with reduced documentation compared to full evaluation

3. Expedited Evaluation Route

Designed for Class C and D devices that have:

·        Multiple reference regulatory country approvals are required

·        Has a proven safety record with at least 3 years of marketing history in the reference regulatory agency countries

·        Hip, knee and shoulder joint replacement non bio-active implants do not qualify for the expedited evaluation route.

The expedited route shortens the review time while still requiring a complete evaluation package. It is ideal for devices used in critical care or with urgent public health value.

4. Full Evaluation Route

This route is required when:

·        The device has no prior reference agency approval, or

·        The manufacturer chooses not to use reliance pathways

·        On top of the general submission documentation, the CSDT file must include detailed information of design verification and validation documents:

o   Full reports of preclinical studies; e.g., physical test data, biocompatibility studies, animal studies and software verification and validation studies

o   Sterilization validation (if applicable)

o   Shel-life studies and projected useful life

·        Clinical evaluation plan and report

·        Manufacturing flow chart

It involves a comprehensive technical review and is typically the longest and most detailed process, especially for Class D devices

Each application is submitted through HSA’s MEDICS portal in ASEAN Common Submission Dossier Template (CSDT) format and must include a range of documents, such as the device description, verification and validation documentation, clinical evidence, risk management documentation, evidence of conformity to Quality Management System standards (e.g., ISO 13485 or MDSAP certification), and Singapore specific documents such as the Singapore Declaration of Conformity or the Essential Principle Checklist. Please note that Class A medical devices are exempt from product registration. However, the applicant will need to complete the Class A Exemption List in MEDICS during the dealer’s license application.

It’s helpful to know that the device registration and dealer’s license application can be carried out in parallel, allowing companies to save time and streamline their market access process in Singapore. This coordinated approach helps reduce delays and ensures a faster route to product launch.

Furthermore, is it important to note that the approvals in the reference regulatory agency countries must be on the same medical device labelled use that is intended for the Singapore market. And approvals from the EU and TGA will quality as independent reference regulatory agency approvals only if the devices have been reviewed and approved by the respective agencies and not registered based on the Mutual Recognition Agreement (MRA). If the latter is the case, both approvals only count as one.

Choosing the right evaluation route is critical to optimizing time-to-market while ensuring compliance with Singapore’s stringent safety standards.

Timelines & Fees

The timelines that the HSA requires for the review of the submission dossier per type of market access route are shown in Table 1. The application process for the wholesaler’s license takes up to 10 working days.

Table 1: Turnaround times

The fees per device type and chosen market access route are shown in Table 2. The application for the wholesaler’s license costs 1.100 SGD.

Table 2: Authority fees

Local Representative

If you’re a medical device manufacturer based outside of Singapore, you are required to appoint a local representative, known as a Registrant, to access the Singapore market. This is mandated under the Health Products (Medical Devices) Regulations 2010.

The Registrant must be a legal entity registered in Singapore and hold the appropriate dealer’s License. Only the Registrant can submit product registration applications to the Health Sciences Authority (HSA) via the MEDICS system. They also act as the main point of contact for regulatory communication and are responsible for maintaining the device’s registration, submitting change notifications, reporting adverse events, and managing any recalls.

This local representative requirement ensures there is a legally accountable party within Singapore who can oversee compliance and engage with HSA throughout the device’s lifecycle.

Concluding remarks

Medical device registration in Singapore is relatively streamlined, thanks to the HSA’s recognition of approvals from reference regulatory agencies such as the US FDA, EU authorities, TGA, and others. This reliance approach significantly shortens review timelines, enabling faster market entry for manufacturers that already hold approvals in one or more of these jurisdictions.

At Qserve, we’ve successfully supported numerous manufacturers in registering their devices through close collaboration with our trusted local partners in Singapore. Our experience navigating the HSA process ensures efficient and compliant market access.

Ready to bring your device to the Singapore market? Get in touch with us today to explore how we can support your registration strategy.