HSA Medical Device Regulations Singapore

Our regulatory consulting specialists support market access in the Singapore medical device market.

Health Products Act (HPA) and the Health Products (MD) Regulations 2010

HSA Medical Device Regulations in Singapore

In Singapore, the Health Sciences Authority (HSA) ensures the safety, quality, and compliance of medical devices and in vitro diagnostic devices (IVDs). These products are regulated under the Health Products Act (HPA) and the Health Products (Medical Devices) Regulations 2010.

Key Responsibilities of the HSA:

  • Guaranteeing medical device safety through rigorous regulatory standards.
  • Overseeing quality control to ensure products meet strict performance benchmarks.
  • Managing vigilance systems to monitor and address risks post-market.

Qserve specializes in guiding medical device and IVD manufacturers through the complexities of the HSA Medical Device Regulations.

GO-TO-MARKET STRATEGY AND REGISTRATION SUPPORT

Do you need assistance with your strategy for HSA Medical Device Regulations in Singapore? 

 

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Medical Device Classification in Singapore

HSA Medical Device Regulations in Singapore

All medical devices in Singapore must be registered in the Medical Device Information Communication System (MEDICS) and approved by the Health Sciences Authority (HSA) before being supplied. However, low-risk Class A devices are exempt from product registration.

The registration and documentation requirements depend on the device's risk classification and the type of evaluation route. Singapore’s regulatory framework offers flexibility by recognizing overseas regulatory approvals from trusted agencies in countries such as:

  • Australia
  • Canada
  • Japan
  • United States
  • European Union

These agencies, known as Overseas Reference Regulatory Agencies, simplify the registration process for devices already approved in these regions.

Singapore’s regulatory system aligns with the countries participating in the Medical Device Single Audit Program (MDSAP), making it useful to include Singapore in your market access strategy. Incorporating an MDSAP-compliant approach not only streamlines Singapore registration but also supports global market entry.

Depending on your existing overseas approvals, data, and evidence, manufacturers can select the most suitable approach to meet the HSA Medical Device Regulations. This tailored strategy ensures compliance while minimizing lead time to market.

Registration routes in Singapore

Submission pathways

Singapore offers four distinct evaluation routes for registering medical devices, depending on the device's risk classification, approval status, and market history. These routes are designed to provide flexibility while ensuring compliance with the Health Sciences Authority (HSA) regulations.

  1. Full Route (With or Without Priority)
    The Full Route is for devices not yet approved by the Overseas Reference Regulatory Agencies. This pathway involves a comprehensive review by the HSA to ensure the device meets Singapore’s safety and performance standards.
  2. Abridged Route
    The Abridged Route applies to devices approved by at least one Overseas Reference Regulatory Agency, regardless of risk classification. This pathway reduces the time and complexity of the approval process by leveraging prior regulatory reviews.
  3. Expedited Route
    The Expedited Route is a fast-track approach for devices based on their overseas approvals and risk class. While overseas approval is a factor, this route also evaluates the device's risk profile to determine eligibility for accelerated review.
  4. Immediate Route
    The Immediate Route is reserved for specific cases, depending on:
  • The device’s risk classification.
  • The number of years the device has been on the market without any safety issues.

This route provides a streamlined process for well-established devices with proven safety records.

Find comprehensive details about the evaluation routes in the blog Things You Need To Know about Medical Device Registration in Singapore.

Global regulatory strategy

Expanding to Singapore before entering other ASEAN markets is often considered a first step to building regional business. Singapore has a well-established regulatory framework, and the government continuously encourages innovation in the medical device and IVD sector. Market approval in Singapore can be an advantage in entering other ASEAN markets. Qserve can support your global regulatory strategy to meet Singapore's HSA Medical Device Regulations.

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Latest Updates on Regulatory Developments

  • GN-23 Guidance on labeling for Medical Devices – Introduction of the UDI
  • GN-16 Guidance on the Essential Principles for Safety and Performance of Medical Devices – Update of Essential Principles for Safety and Performance following the introduction of the UDI
  • GN-15 Guidance on Medical Device Product Registration – Addition of regulatory approvals for abridged and immediate evaluation routes.

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Qserve services for Singapore

  • Global Regulatory Strategy
  • Registration support in Singapore
  • HSA certification
  • Singapore Registrant support
  • Submission file support
  • Translation labels and IFUs based on requirements

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Representation for foreign manufacturers

Singapore Registrant

Companies without a physical establishment in Singapore must appoint a local authorized representative, also known as a Registrant, to operate legally in the medical device market. This requirement is mandatory under Singapore’s Health Sciences Authority (HSA) Medical Device Regulations.

Key Responsibilities of the Registrant:

  • Act as the official point of contact between the company and the HSA.
  • Handle regulatory processes, including medical device registration.
  • Ensure compliance with Singapore’s regulatory requirements.

Any company intending to manufacture, import, or supply medical devices in Singapore must obtain a dealer’s license. This license is typically secured by the Registrant on behalf of the foreign legal manufacturer. The license ensures all activities comply with Singapore’s safety and quality standards.

More information

Additional Regulatory Requirements

Communication with HSA

Singapore's Health Sciences Authority (HSA) manages all medical device submissions and registrations through its fully digitized platform, MEDICS. This user-friendly platform ensures an efficient and streamlined registration process for manufacturers and facilitates precise and effective communication.

  • Document Review and Input Requests (IR)
    Once the HSA reviews the submitted documents, they may request additional information via an Input Request (IR). The Registrant or other linked account automatically receives a notification for the IR, ensuring prompt communication.
  • Pre-Market Consultation Options:
    Manufacturers can consult with the HSA pre-market through two options:
  1. Clinically Focused Consultation: For medical device development emphasizing clinical aspects.
  2. Pre-Submission Consultation: Focused on the device dossier and supporting documents to ensure compliance with HSA regulations.

All communication with the HSA is conducted in English, and submission files are also accepted in English. This ensures clarity and consistency throughout the registration process.

Medical Device Registration and IVDs

Achieve regulatory compliance

Our regulatory consulting specialists support market access in the Singapore device market. Based on your current compliance, we can conduct a gap analysis to determine the overlap and missing elements on how to complete the technical documentation efficiently. Qserve knows the essential requirements to ensure how to achieve regulatory compliance. 

Regulatory timelines and fees

How long does it take to enter
the Singapore medical device market? 

The turnaround times are depending on the risk class and the type of evaluation route:

  • Class B: up to 160 working days
  • Class C: up to 220 working days
  • Class D: up to 310 working days