Medical Device Registration
Before any medical devices can be imported, distributed or marketed in Singapore, they have to be registered with the Health Sciences Authority (HSA). Only a license holder or Registrant of a local incorporated company can submit medical device registrations. Singapore HSA follows GHTF guidelines for medical device classification.
Medical devices in Singapore are classified based on a four-tier system, Class A, B, C and D, with Class A covering lowest-risk products and Class D covering highest-risk products. The registration process and requirements for each risk class varies in terms of information and depth of documentation required.
As long as annual listing fees are maintained and post-market vigilance requirements are met, registrations do not expire.
In registering your medical device, we will manage the submission from the point of introduction to relevant contact person from principal to the final approval of the product, including but not limited to the following activities:
1. Provide principal with the requirements to compile the dossier.
2. Provide templates and checklist wherever possible to simplify the process
3. Compile and submit dossiers as per local requirements under the online portal, Medics
4. Submit the dossiers in a timely manner to meet datelines
5. Ensure smooth and efficient registration process for your device
6. Act as liaison between HSA and the principal during evaluation process. Keeping track of datelines for responses, clarifying queries and meeting officers to resolve issues if required.
7. Closely follow up on registration progress
8. Responding to ministry’s queries including input requests upon screening of the dossiers
9. Seeing the process through till the completion of the registration process of the dossier
With our strong resources and expert knowledge, we will fully support your medical device registration with HSA. We can advise on the grouping of your medical devices in a single registration, saving registration costs and allowing higher efficiency for your products to be marketable in Singapore, in a timely manner.
If desired, we can use your Singapore registration dossier to ease your entry into other Southeast Asian markets such as Malaysia.