Medical Device

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1. Why us?

The Health Sciences Authority (HSA) is the regulatory body responsible for evaluating and approving medical devices in Singapore to ensure their safety, quality, and effectiveness before they are marketed.

Registering your medical device is a legal requirement for importation, distribution, and sale in Singapore. It ensures that your product has undergone rigorous evaluation based on national standards, thereby building trust with healthcare providers and end-users.

As a dedicated regulatory consulting firm, we hope to guide you through every step of the registration process — from determining device classification, selecting the appropriate evaluation route, to compiling submission dossiers and liaising with the HSA. Our expertise ensures smoother market entry, so you can focus on innovation and business growth.

2.What is a Medical Device?

In Singapore, a medical device refers to a health-related product that achieves its intended purpose primarily through physical or mechanical means, rather than pharmacological, immunological, or metabolic action.

Examples of Medical Devices in Singapore

These products are classified as medical devices and are regulated by the HSA:

Blood Glucose Meter
Pregnancy Test Kit
Lubricating or moisturising eye drops
Blood refrigerators and freezers used to store blood/blood products for transfusion
Powered contact lenses
Acupuncture needles
Dental equipment like aligners and retainers

That means, in regulatory terms, these products require registration and approval from HSA before they can be legally marketed or distributed in Singapore.

What is Not Considered a Medical Device?

Products such as massage tools, wellness gadgets, or body-toning machines that do not make specific medical claims and are not intended for medical purposes are generally not classified as medical devices under HSA.

Best to Check with us!

There are many different type of products that can be classified as medical devices, and it varies greatly between different countries. The risk classification may vary greatly, even within SEA. Send in a product enquiry for free to know the classification help you better plan your business strategy!

3. Medical Device Registration

We will assist companies to ensure that they comply with the regulatory requirements before any import, wholesale and manufacture of medical devices in Singapore.

Business Registration - Ensuring that your business entity is registered with the Accounting and Corporate Regulatory Authority (ACRA) locally.
Application for the relevant Dealer’s Licenses - Apply for the relevant Dealer License depending on your business activity.
Medical Device Registration - Medical devices must be registered with HSA before they can be supplied in Singapore.

The registration evaluation routes for registering a Medical Device in Singapore depends on its risk classification, the duration of safe marketing history, and whether it has prior approval by overseas reference regulatory bodies (Australia, Europe, Canada, Japan and the United States of America)

HSA classifies medical devices into Classes A, B, C, and D according to the Global Harmonization Task Force (GHTF) guidelines, based on the device’s risk level from low to high respectively.

  
  Registration Requirements by Risk Classification

    Risk Class
    Registration
    Evaluation Routes
    Conditions & Notes
  
      Class A
(Low Risk)
    
      NOT mandatory
    
      Product Notification
    
      Submit Product Notification Application.

      Dossiers must be maintained on file.
    
      Class B
(Low–Medium)
    
      Registration required
    
      Full Evaluation

      Abridged Evaluation

      Expedited Routes

      • ECR-1

      • ECR-2 / EDR
    
      Priority Review ~35% faster than full route.

      IBR allows immediate entry when conditions met.

      Review closure approx. 6 months.
    
      Class C
(Medium–High)
    
      Registration required
    
      Full Evaluation

      Abridged Evaluation

      Expedited Routes

      • ECR-1

      • ECR-2 / EDR
    
      Priority Review ~35% faster.

      Expedited routes ~2 months faster (stricter criteria).

      Immediate route only for standalone mobile apps.
    
      Class D
(High Risk)
    
      Registration required
    
      Full Evaluation

      Abridged Evaluation

      Expedited Routes

      • ECR-1

      • ECR-2 / EDR
    
      Same conditions as Class C for ECR/EDR.

      Combination medical devices require one submission only.

5.Turn-Around-Time (TAT)

Fees and processing times vary based on the selected evaluation route for your medical device. While Singapore does not impose a sunset clause on registrations, an annual retention fee is required to maintain the product's registration status.

Medical Device Registration	TAT (in working days)
Class B
Immediate Class B Registration	Immediate upon submission
Abridged evaluation	100
Full evaluation	160
Full evaluation (Priority Review Scheme Route 1 and Route 2)	104
Class C
Immediate evaluation	Immediate upon submission
Expedited evaluation	120
Abridged evaluation	160
Full evaluation	220
Full evaluation (Priority Review Scheme Route 1 and Route 2)	143
Class D
Expedited evaluation	180
Abridged evaluation	220
Full evaluation	310
Full evaluation (Priority Review Scheme Route 1 and Route 2)	202

Reference: [4] Fees and turnaround time for medical devices, reference here

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Risk Class	Registration	Evaluation Routes	Conditions & Notes
Class A (Low Risk)	NOT mandatory	Product Notification	Submit Product Notification Application. Dossiers must be maintained on file.
Class B (Low–Medium)	Registration required	Full Evaluation Abridged Evaluation Expedited Routes • ECR-1 • ECR-2 / EDR	Priority Review ~35% faster than full route. IBR allows immediate entry when conditions met. Review closure approx. 6 months.
Class C (Medium–High)	Registration required	Full Evaluation Abridged Evaluation Expedited Routes • ECR-1 • ECR-2 / EDR	Priority Review ~35% faster. Expedited routes ~2 months faster (stricter criteria). Immediate route only for standalone mobile apps.
Class D (High Risk)	Registration required	Full Evaluation Abridged Evaluation Expedited Routes • ECR-1 • ECR-2 / EDR	Same conditions as Class C for ECR/EDR. Combination medical devices require one submission only.