The medical device sector in Singapore has experienced remarkable growth, driven by the nation’s favorable business environment, robust intellectual property protections, and expanding healthcare demands. However, navigating the high standards and stringent regulatory requirements can be challenging. A thorough understanding of the medical device registration process is essential for manufacturers seeking compliance and a smooth market entry.

This comprehensive guide delves into the regulatory framework, device classification system, and specific compliance requirements in Singapore. By breaking down the complexities, we aim to equip you with the knowledge and tools necessary to manage the medical device registration process effectively, ensuring approval and success in Singapore’s competitive healthcare landscape.

Understanding The Regulatory Framework

Central to the regulatory framework is Health Sciences Authority (HSA), the principal authority tasked with overseeing the safety, quality, and efficacy of medical devices available on the market. As the gatekeeper for public health, HSA certifies that all devices meet stringent standards before they can be introduced to healthcare settings. This responsibility encompasses the entire lifecycle of the devices, from initial registration through to post-market surveillance.

Key Responsibilities of HSA

HSA establishes and enforces a robust set of regulations and guidelines for the manufacture, import, sale, and distribution of medical devices. These rules are designed to make sure that all devices meet high safety and performance standards, safeguarding both patients and healthcare providers.

Medical devices are categorised into four classes—A, B, C, and D—based on their risk levels. The regulatory authority issues licences and permits according to these classifications, determining the extent of scrutiny each device must undergo before it can be marketed. This system streamlines the registration process while upholding stringent safety requirements.

When a device is submitted for registration, they conduct a thorough review that includes technical assessments and compliance checks. Approval is only granted when the device meets all relevant standards, ensuring its safety and effectiveness for its intended use.

Once a medical device is on the market, HSA continues to monitor its performance and safety. This includes overseeing vigilance systems, managing adverse event reports, and conducting periodic inspections to ensure ongoing compliance. This ongoing surveillance helps to swiftly address any issues that may arise post-approval.

Functions

HSA develops policies and guidelines that align with international standards, fostering regulatory harmonisation and facilitating easier market access for the devices. These policies help keep Singapore’s regulatory framework current and effective in a global context.

To support compliance and best practices, they provide guidance and assistance to manufacturers, importers, and healthcare professionals. This is essential for maintaining high industry standards and promoting a culture of regulatory excellence.

HSA also works closely with international regulatory agencies, industry associations, and healthcare institutions. These partnerships are vital for aligning global regulations, sharing valuable information, and addressing emerging challenges in the medical device sector.

Regulatory Requirements for Medical Devices

Understanding the regulatory requirements for medical devices is essential for manufacturers aiming for compliance and successful market entry. The devices are classified by their risk levels, with each class having its own set of regulatory demands. This classification helps outline the necessary level of scrutiny and documentation for registration. In this section, we’ll delve into how the devices are categorised and the criteria used to assess their risk levels.

Classification of Medical Devices in Singapore

• Class A Devices

Class A devices are considered low-risk and typically have minimal impact on patient safety. They are usually non-invasive and do not enter the body. As they pose minimal risk, the regulatory requirements for Class A devices are relatively straightforward. Common examples of Class A devices are:

• • Tongue Depressors: These devices are simple and pose a negligible risk.
  • Bandages: These are considered low-risk and do not involve invasive procedures.
  • Wheelchairs: Designed to aid mobility, wheelchairs are non-invasive and have minimal impact on patient health.

• Class B Devices

Class B devices are classified as low to moderate-risk and generally involve some degree of invasiveness. These devices may be used for procedures that penetrate the skin or mucous membranes but generally pose manageable risks. Examples of Class B devices include:

• • Hypodermic Needles: These needles are used for injections or drawing blood. They penetrate the skin but are equipped with safety features to minimise risks.
  • Prescription Contact Lenses: The lenses come into direct contact with the eyes and require careful handling to prevent infections.
  • Therapy Lasers:  The equipment provides hot and cold therapy for treatment of fibromyalgia.

• Class C Devices

Class C devices are classified as moderate to high-risk due to their invasive nature and the higher potential for risk. These devices are often used in more critical medical situations and require thorough evaluation. Class C devices include the following:

• • Ventilators: Essential for supporting or replacing breathing, ventilators are complex devices with significant health implications.
  • Bone Fixation Plates: The plates are implanted into the body and must meet high safety standards. 

• Class D Devices

Class D devices are considered high-risk and can have serious health consequences if they malfunction or are used improperly. These devices are typically used in life-supporting or life-sustaining situations. Some examples of Class D devices are:

• • Heart Valves: Critical for managing heart function, valves are implanted into the body and must be meticulously regulated.
  • Implantable Defibrillators: These devices, which correct life-threatening cardiac arrhythmias, require stringent regulatory oversight due to their complexity and potential impact on patient health.

Criteria for Classification Based on Risk

The criteria for classifying medical devices based on risk are multifaceted and play a crucial role in determining the appropriate regulatory pathway. One primary factor is the device’s intended use. This involves understanding how the device interacts with the human body and its primary function. Devices used for invasive procedures or critical functions typically fall into higher-risk categories because of their significant impact on health.

Another important factor is the degree of invasiveness, which examines whether the device penetrates the body and the extent of this interaction. Devices that penetrate the skin or enter body cavities face more scrutiny due to the heightened risk involved. The duration of contact between the device and the patient also influences classification; devices with prolonged or repeated contact are subject to stricter evaluation to identify any potential adverse effects.

Additionally, the potential risks associated with device malfunction or incorrect use are assessed. Devices with higher potential risks are placed in higher-risk categories to ensure thorough evaluation. 

Finally, technological characteristics such as the complexity and mechanism of action of the device also affect its regulatory path. Devices with advanced technology or complex mechanisms usually require more detailed scrutiny to confirm their safety and effectiveness.

Read more: What is a Borderline Medical Device in ASEAN Terms and Published List for Your Reference?

Preparing for the Registration Process

Preparing for the medical device registration process in Singapore requires a clear understanding of the documentation requirements and regulatory pathways, which differ based on the device‘s risk classification. Here, we break down the preparation steps and necessary documents for each device class and outline the different routes you can take.

Documentation Requirements for Different Classes

I. Class A (Low Risk):

Class A devices are classified as low-risk and are generally exempt from registration.

For Class A devices, which are considered low-risk, registration is generally exempt. However, they must still meet the Essential Principles for Safety and Performance before being marketed. Manufacturers need to list these devices on the Class A Exemption List in the Medical Device Information Communication System (MEDICS) as part of their dealer’s licence application. While the process for Class A devices is more straightforward, adherence to safety and performance standards remains mandatory to make sure that they are safe to use.

II. Class B, C & D (Higher Risk):

For higher-risk devices classified as Class B, C, or D, a formal registration application must be submitted through MEDICS, along with various supporting documents. The documentation required depends on the evaluation route chosen but will includes the following :

• ASEAN Common Submission Dossier Template (CSDT):  To be aligned according to technical requirements of General Medical Devices or In vitro diagnostic devices.
• Proof of Quality Management System (QMS) Compliance: Class B, C, and D devices must show they meet recognised QMS standards like ISO 13485, US FDA cGMP, or Japan MHLW Ordinance #169.
• Declaration of Conformity to Essential Principles: A declaration of conformity to a set of relevant standards applicable to the device with supporting  pre-clinical and clinical test reports .
• Additional Documents: This will be dependent on the evaluation pathway of the device.

Regulatory Pathways

Navigating the regulatory pathways involves selecting the appropriate route based on your device’s existing approvals and classification. Each route has its own set of requirements and processes, all aimed at ensuring that devices meet the necessary safety and effectiveness standards before they enter the market.

A. General Requirements

Regardless of your chosen route, all applications must be submitted electronically through the HSA’s Medical Device Information Communication System (MEDICS). All documentation must be in English. 

A Singapore-based Licensed Person (individual) or Authorised Representative (company) must manage the registration process. This person or entity is responsible for communicating with the HSA and making sure all regulatory requirements are met. Additionally, a dealer’s licence is needed for importing, distributing, or wholesaling medical devices, highlighting the importance of thorough regulatory compliance throughout the device’s market journey.

B. Evaluation Routes

In Singapore, there are several evaluation routes  based on the device‘s approval status in reference countries  and  risk classification:

1. Immediate Route (IBR) : This is the quickest option for Class B devices.  To qualify, the device must be approved by at least two Reference Countries, such as the United States or the European Union, and must have been marketed for at least three years with no safety issues. This route is ideal for devices that are already well-regulated in major markets, allowing for a faster approval process in Singapore.

2. Expedited Route (ECR/EDR): This route provides a faster registration process for Class C and D devices. To use it, the device must have approval from at least one Reference Country for a labelled use identical to that intended for marketing in Singapore with no safety issues globally and marketed for at least 3 years. This option is advantageous for devices with established international approvals, enabling quicker market entry in Singapore. Implantable devices and hip, knee or shoulder replacement are not applicable for expedited routes.

3. Abridged Route: Available for Class B, C, and D devices with approval from one Reference Country for a labelled use identical to that intended for marketing in Singapore. This route offers a simplified process with potentially fewer documentation requirements. However, specifics can vary based on the device and the standards of the Reference Country.

4. Full Route: The Full Route is the most comprehensive and is required for devices without approvals from any Reference Countries. It demands extensive technical documentation to prove the device’s safety, effectiveness, and compliance with regulatory standards. This route is designed for new or less well-known devices that require a detailed evaluation to enter the Singaporean market.

Read more: Steps to Incorporate New Regulation Changes in Approved Marketing Authorisation (MAs)

Documents Required by Route

When preparing to register your medical devices in Singapore, the documentation requirements vary depending on which evaluation route you choose. Each route has specific documentation needed to ensure that the device meets the country’s regulatory standards. Here’s a detailed breakdown of what you’ll need for each route:

A. Common Documents (All Routes)

1. ASEAN Common Submission Dossier Template (CSDT):

• • Immediate/Expedited Route: For these routes, the CSDT must include a summary of the device’s approvals and marketing history from Reference Countries. This summary shows the device’s proven track record in other regulated markets, supporting its safety and efficacy claims.
  • Abridged Route: The CSDT should reference existing registration documents from the Reference Country. If these references aren’t already in English, they may need to be translated. This route uses existing approvals to simplify the registration process.
  • Full Route: The Full Route requires complete technical documentation. This means providing detailed information that proves the device’s safety, efficacy, and compliance with regulatory standards. This route is the most comprehensive and requires extensive documentation.

2. Device Description:

This document provides detailed information about the device, including its intended use, technical specifications, and the materials used in its production. A complete description helps the regulatory body understand how the device functions and interacts with users.

Summary of Design Verification and Validation

Contains a series of testing reports both pre–clinica and clinical to demonstrate the safety and performance of the device.

3. Risk Analysis:

A thorough risk analysis should pinpoint potential hazards related to the device and describe strategies to manage these risks. This analysis is important for assessing the device’s safety and making sure that appropriate risk management measures are in place.

4. Device Labelling:

Draft labels must be in English and meet HSA regulations. They must also include all essential details, such as device identification, usage instructions, and safety warnings, to ensure that users have clear and accurate information about the device.

5. Instructions for Use (IFU):

Detailed instructions in English are required for the safe and effective use of the device. The IFU should address everything from setup and operation to maintenance and troubleshooting so users can handle the device safely and effectively.

6. Proof of QMS Compliance:

You’ll need a certificate demonstrating that your device complies with a recognised Quality Management System (QMS). Accepted standards include ISO 13485, US FDA cGMP, or Japan MHLW Ordinance #169. This certificate confirms that the device’s manufacturing processes meet international quality standards.

B. Additional Documents 

a. Proof of Approval from Reference Regulatory Agencies: Evidence of approval from both Reference Regulatory Agencies (such as the US FDA and EU notified body ) is required. This shows that the device has been evaluated and approved by multiple reputable regulatory bodies.

b. Marketing History Documentation: Documentation that provides details of the device’s marketing history in these countries, including any adverse events or issues.

c. Declaration of No Safety Issues Globally: This is a formal declaration confirming that no safety issues have been reported globally with the device.

Medical Device Registration Steps

Registering a medical device in Singapore involves several key steps to make sure that the device meets regulatory standards and is safe for use. This process is crucial for getting approval to market the device and requires careful preparation and detailed documentation. Each step is designed to confirm the device’s safety, effectiveness, and compliance with local regulations.

Understanding and following these steps carefully allows you to streamline the approval process and avoid potential delays. Let’s take a closer look at the key stages, starting with pre-submission preparation.

Pre-submission Preparation

Before starting the registration process, it’s essential to prepare thoroughly. This means making sure all necessary documents are complete and accurate. You’ll need to gather key documents, carry out risk assessments, and review clinical data to prove the device’s compliance and safety.

A. Gathering Necessary Documentation

1. Technical Documentation

This includes detailed information about the device’s design, specifications, and manufacturing processes. It’s important to provide documents showing compliance with relevant standards like ISO. Examples of technical documentation include technical drawings, schematics, and assembly procedures, all outlining the device’s construction and operational features.

2. Quality Management System (QMS) Documentation

It’s crucial to show that quality controls are effectively implemented throughout the device’s lifecycle. Quality Management System (QMS) documentation includes procedures and records that highlight these processes. This may include calibration records, inspection reports, batch records, and detailed protocols for testing and validation. These documents help assure regulators that the device is manufactured under strict quality control measures.

3. Clinical Data and Evidence

For higher-risk devices like Class C and D , clinical data is vital to demonstrate safety and efficacy. This involves clinical trial data, investigation reports, and summaries of clinical studies. Essential documents in this category include clinical investigation reports, patient data, and informed consent forms. This evidence supports the claim that the device performs as intended without posing undue risks to patients.

B. Conducting Risk Assessments and Clinical Evaluations

1. Risk Assessments

Identifying potential hazards associated with the device is a fundamental part of the pre-submission process. Risk assessments utilise tools like Failure Mode and Effects Analysis (FMEA) to evaluate potential risks and develop strategies to mitigate them. This involves creating detailed risk management plans and hazard analysis reports to address and control all possible issues.

2. Clinical Evaluations

Clinical evaluations assess the device’s performance and safety based on available clinical data. This step involves verifying that the device functions as intended without posing unnecessary risks. Documentation for this process includes summaries of clinical data, clinical evaluation reports, and post-market surveillance plans to monitor the device’s performance once in use.

Thorough pre-submission preparation confirms that all aspects of the device’s safety, quality, and efficacy are covered. Proper documentation and risk assessment lay the groundwork for a successful registration process, helping to streamline approval and maintain compliance with Singapore’s regulatory standards.

Submission Process

Submitting a medical device registration application is a structured and detailed process to meet the HSA’s requirements. Every step is designed to thoroughly evaluate the device’s safety, efficacy, and regulatory adherence. Below is an overview of the submission process and what you can expect at each stage.

Detailed Steps for Submitting Registration Applications:

1. Initial Application Preparation:

Before submitting your application, gather and carefully prepare all required documentation, such as compiling technical files, clinical data, and quality management system (QMS) records. Ensure that all documents comply with the specific requirements set by the HSA. This step is important as incomplete or non-compliant documentation can lead to delays or rejections.

2. Submission to HSA:

Submit the completed application package through the HSA’s designated electronic submission portal (MEDICS). Your submission must include all necessary forms, certificates, and supporting documents as outlined in the HSA submission guidelines. Double-check that every required document is included to avoid processing delays.

3. Application Review:

Once submitted, HSA conducts an initial review to assess the completeness and compliance of your application. The review includes checking for accuracy and confirming that all documentation adheres to regulatory requirements. This preliminary stage is crucial for identifying any immediate issues that need to be addressed before more detailed evaluations begin.

4. Technical Assessment:

An in-depth technical assessment of the medical device will be conducted, which involves a detailed review of design specifications, manufacturing processes, and QMS documentation. The goal is to confirm that the device meets regulatory standards and functions safely and effectively as intended. This step is critical for verifying the device’s technical soundness.

5. Clinical Evaluation Review:

For higher-risk devices such as Class B, C, and D, clinical trial data and performance reports  are reviewed. This assessment assesses whether the clinical evidence provided supports the device’s safety and efficacy claims. The clinical evaluation is a key component in determining the device’s suitability for market approval.

6. Decision Making:

Based on the outcomes of the technical assessment and clinical evaluation, HSA decides on the application. They may approve it, request further information, or reject it. The decision is communicated to the applicant within a set timeframe, offering clear guidance on any next steps or required actions.

Timeline Expectations and Processing Stages:

• Initial Review: This stage is typically completed within a few weeks to a month after submission, although the exact timeframe can vary depending on the workload and complexity of the application. The focus here is on making sure all initial requirements are met.
• Technical Assessment: Assessments at this stage can take several months, particularly for complex devices that require detailed scrutiny of technical documentation and manufacturing processes. The depth of this assessment ensures that all technical aspects are carefully evaluated.
• Clinical Evaluation: If clinical data is needed, it will add additional time as the HSA reviews the safety and effectiveness based on clinical trials. The duration varies depending on the complexity and volume of data submitted.
• Decision Making: While HSA aims to provide a decision within a specific timeframe after completing the review stages, actual processing times can vary based on the specifics of the application and any additional requests for information.
• Post-Submission Follow-up: After submission, be prepared to respond promptly to any requests for additional information or clarifications (RFIs) from the HSA. Timely responses can help avoid delays and keep the approval process on track.

Read more: How to review and plan for the next regulatory cycle of activities

Post-Submission Activities

Once you’ve submitted your application, the next step is to manage communications and address any issues that may arise during the review process. How you handle these post-submission activities is key to keeping things on track and achieving a positive result. Here’s how to navigate this phase:

You might want to check out our subscription plan which might support your post-licensing activities: https://theregconsultants.com/product/basic-regulatory-subscription-plan/ 

Handling Queries from HSA

Keep a close eye on all communications from the HSA regarding your application. This includes checking your email regularly and monitoring the HSA’s electronic submission portal for any updates or requests. Quickly noting and responding to any queries or requests for additional information is essential to keep the review process moving smoothly.

When responding to queries, make sure your answers are both prompt and accurate. Address each query thoroughly and provide all requested information or documentation. Clear and organised communication is essential to avoid unnecessary delays and keep the review process on track.

Addressing Deficiencies and Follow-up Actions

If HSA identifies deficiencies during the review process, they will issue input requests. Carefully review these input request  to pinpoint the specific concerns or deficiencies. Address each issue by providing additional data, updating documentation, or making corrections as requested. Each deficiency must be accurately handled to ensure compliance and facilitate a smoother review process.

Stay actively engaged throughout this follow-up phase. Collaboration is essential for resolving any outstanding issues or concerns. Maintain open lines of communication with HSA representatives, provide timely updates on corrective actions, and seek clarification if you’re unsure about any aspect of their requests. This helps build a constructive dialogue and makes certain that all concerns are fully addressed.

Keep detailed records of all communications and actions related to any queries and deficiencies. This documentation is useful for tracking your application’s progress and for future follow-ups or audits. Accurate record-keeping also helps maintain a clear and transparent process.

Before finalising any responses or submissions, verify that all requested information and documentation have been included and correctly addressed. Ensure that all corrections are complete and that any additional data is relevant and precise. Confirm with the HSA that they have all the necessary information to proceed with the review.

Frequently Asked Questions

Steering through the registration process can be challenging, and it’s normal to have questions along the way. To help you better understand the key aspects of registration and address any concerns you might have, we’ve compiled answers to some of the most frequently asked questions.

1. What are the key differences between Class A, B, C, and D medical devices? 

In Singapore, medical devices are classified into four risk categories:

• Class A: Low-risk, non-invasive items like tongue depressors or bandages.
• Class B: Moderate-risk devices such as digital thermometers or blood pressure cuffs.
• Class C: Higher-risk devices, including implantables or blood glucose monitors.
• Class D: Highest-risk devices like pacemakers or artificial heart valves.

As the risk level increases, so do the registration requirements, with Class D devices undergoing the most rigorous evaluation.

2. How long does the process typically take in Singapore? 

The time it takes for medical device registration can vary widely depending on factors such as the complexity of the device, the completeness of your submission, and HSA’s current workload. Typically, the process can range from several months to more than a year. Initial reviews and technical assessments usually take a few weeks to a few months. If your device requires clinical evaluations, the process may be longer. To avoid delays, it’s important to respond promptly to any queries or requests for additional information.

3. What are the common reasons for registration application rejections? 

Registration applications may be rejected for several reasons, such as incomplete documentation, failure to meet regulatory standards, or insufficient clinical evidence supporting safety and efficacy claims. Common issues include missing technical files, inadequate clinical data, or non-compliance with quality management system requirements. Additionally, misinterpreting regulatory guidelines or not addressing queries and deficiencies can also lead to rejection. To increase your chances of approval, make sure your documentation is thorough and engage proactively with HSA throughout the process.

Registering a medical device in Singapore requires a careful and detailed approach. It’s important to understand the different device classes and ensure your application meets HSA guidelines. Keep communication open with the authority throughout the process, both before and after approval. By proactively addressing potential issues, you can avoid delays and make the process smoother and more efficient.

For expert guidance and support through every stage of your registration journey, consider partnering with a regulatory affairs services provider. At The Reg Consultants, our experienced team will ensure that your medical device meets all HSA regulations and is positioned for a successful market entry. We offer tailored solutions and comprehensive guidance to make the registration process as smooth and efficient as possible.

Get in touch with us today to discover how we can help you achieve your medical device registration goals in Singapore.

As standards of living and healthcare quality rise, the demand for pharmaceuticals, medical devices, and other medical commodities, collectively called health products, is on the rise. With more products entering the market, it’s vital to have robust regulatory systems in place to ensure timely access to safe and effective therapies. Strengthening the registration framework is essential for maintaining high standards and protecting public health. In this article, we will delve into five strategies shaping Singapore’s approach to health product regulation, from aligning with international best practices to effectively engaging stakeholders.

Regulatory Harmonisation

A key element of a robust regulatory system is its alignment with international best practices. Singapore has been diligently working to harmonise its standards with global regulations, such as those set by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and IMDRF (International Medical Device Regulators Forum). This alignment not only bolsters Singapore’s reputation as a trustworthy market but also makes it easier for both local and international companies to access the market. This fosters innovation and attracts investment, strengthening the country’s position as a reliable and forward-thinking regulatory environment.

Capacity Building in Regulation

A strong regulatory environment relies on a skilled workforce. Singapore has made significant investments in capacity-building programmes to boost the knowledge and skills of its regulatory personnel. These initiatives offer specialised training and professional development, keeping regulators up-to-date with the latest advancements and practices. This focus on human capital development is necessary for ensuring that regulatory decisions are informed, timely, and risk-based.

Read more: Navigating Regulatory Changes in Singapore’s Healthcare Industry

Digitalisation and Automation

The adoption of digitalisation and automation has marked a significant step forward in modernising Singapore’s health product regulatory system. Streamlined registration and approval processes have become more efficient and transparent thanks to these initiatives. Digital tools like electronic submission systems and automated tracking for product defects have boosted both speed and accuracy in regulatory work. This modern approach improves operational efficiency, enhances data management, and supports better decision-making, benefiting both regulators and the industry.

Post-Market Surveillance

Post-market surveillance is another critical strategy for strengthening the regulatory framework. It involves monitoring the safety and effectiveness of health products once they are available to consumers. In Singapore, robust mechanisms are in place to keep track of product performance and address any issues quickly. This includes regular inspections, reporting systems for adverse events, and continuous evaluation of products. By keeping a close watch on health products after they hit the market, potential risks are swiftly managed, helping to protect public health and maintain trust in the regulatory system.

Read more: Responsibilities of a Marketing Authorisation Holder (MAH)

Stakeholder Engagement

Stakeholder engagement plays a vital role in strengthening regulatory systems. Working closely with industry stakeholders, healthcare professionals, and the public helps make regulatory policies more informed and effective. Open dialogue and feedback from various groups allow regulatory authorities to better understand the needs and concerns of those affected by their decisions. This collaborative approach improves the development of regulatory strategies and supports the implementation of new regulations, leading to a more effective and responsive regulatory framework.

Read more: Elevate Your Business With A Regulatory Affairs Management Subscription Plan

In conclusion, the strategies we’ve outlined work together to create a robust and flexible regulatory framework that protects public health while encouraging innovation and economic growth.

At The Reg Consultants, we recognise that navigating the regulatory landscape for health products can be complex. We specialise in offering comprehensive regulatory consulting services to simplify the process. Whether it’s identifying gaps in your dossier, conducting detailed regulatory intelligence, or providing pre-market consultations, we’re here to help you tackle compliance challenges and support your success.

Contact us today to find out more about how we can help you achieve regulatory success

In the world of healthcare, regulatory compliance is the foundation upon which patient safety and industry integrity are built. That is why when it comes to introducing a medical device to the Singaporean market, there are stringent demands of regulatory compliance to ensure utmost safety, reliability and efficacy. 

In this blog, we delve into the medical device registration process in Singapore, ensuring you adhere to the necessary regulations and providing essential insights for a successful registration. 

Understanding the Medical Device Registration Regulatory Framework in Singapore

The Health Sciences Authority (HSA) in Singapore plays a pivotal role in the evaluation and approval of medical devices. Companies must secure a dealer’s license prior to engaging in the manufacturing, import, or distribution of medical devices. It is a prerequisite that all medical devices undergo registration with HSA before they can be legally distributed in Singapore. 

The evaluation route for your medical device depends on several factors, including the risk classification, prior approvals, and the duration of safe marketing history. The risk classification categorises devices as A (low risk), B (low to moderate risk), C (moderate to high risk), and D (high risk). Determining your device’s classification is a crucial first step, and HSA offers a tool to simplify the process.

However, Class A low-risk medical devices are exempt from the product registration requirement. While Class A medical devices are excluded from product registration, it is important to include the Class A Exemption List within your dealer’s license application through the MEDICS platform.

During the evaluation process, HSA will review the information presented in MEDICS and also the CDST that is shared. It is key to be prompt and comprehensive in your responses, as any delay in furnishing the necessary information may result in a longer medical device registration process.

Furthermore, the Priority Review Scheme expedites the registration and market entry process for medical devices, providing a faster route for approval. This scheme is applicable exclusively to Class B, C, and full evaluation route for Class D devices. Take note that Class D devices with a registrable drug in a secondary role are excluded from this scheme. Under the Priority Review Scheme, the turnaround time (TAT) is significantly shorter, with a 25% reduction compared to the TAT associated with the standard full route.

In certain circumstances, the HSA may grant approval for the import and distribution of unregistered medical devices through the utilisation of Special Access Routes. These situations encompass scenarios such as the import of re-export unregistered devices, unregistered devices intended for non-clinical purposes, custom-made medical devices, and various other specific cases.

Tips for a Successful Medical Device Registration

Here are some valuable tips and insights to ensure your journey towards medical device registration in Singapore is not only smooth but also successful.

• Engaging Experts

It is highly advisable to seek assistance from local experts or consultants well-versed in the regulatory landscape of Singapore. Their experience and understanding of the system can help you to navigate the complexities of the medical device registration process with ease, ensuring compliance and efficiency.

At The Reg Consultants, we provide expert guidance and support throughout the entire registration process ensuring compliance with local GN regulations.

• Thorough Documentation

Make sure all required documentation is not only complete but also accurate. Attention to detail is critical as any discrepancies or omissions can lead to delays or even rejection of your registration. 

• Understand Risk Classification

Familiarise yourself with the risk classification system in Singapore. Knowing the category your device falls under is a major factor as it determines the evaluation route and registration requirements. 

• Compliance with Standards

Your medical device must meet the relevant safety and quality standards. This includes having ISO 13485  certification for medical devices, which is often a fundamental requirement for registration.

Simplifying Compliance at The Reg Consultants

Our mission is clear: to simplify compliance and empower your business to thrive in the complex landscape of medical device registration. With our support, you can navigate compliance with confidence. 

Get in touch with us to find out more.