HSA Circular to Exhibition Attendees


Click here to download the circular

   

Legal Control for Medical Devices in Singapore


In Singapore, medical devices are subject to regulation under the Health Products Act. Under this law, all medical devices are required to be registered before any supply can be legally carried out, unless otherwise exempted under the provisions of the law. Thus, the supply of an unregistered medical device is an offence under Singapore’s law and is liable on conviction to a fine not exceeding $50,000 or to a jail term not exceeding 2 years or to both.    With this, the Health Sciences Authority would like to remind all exhibition attendees that any unregistered medical device which is permitted for display at the exhibition shall not be taken as samples or purchased for used locally.  
   

Notice to Healthcare Professionals


Healthcare professionals who wish to obtain any unregistered medical devices for local clinical use shall make an application to the HSA via the following authorization routes prior to supply:    GN‐26: Authorisation Route for Import and Supply of Unregistered Medical Device on Request by Qualified Practitioner for Use on his Patient  GN‐27: Authorisation Route for Import and supply of Unregistered Medical Devices to a Private Hospital, Medical Clinic or Clinical Laboratory licensed under the PHMC Act for the use on their patients
Further information regarding the Special Authorisation Routes of supply can be obtained via the weblink, http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Medical_Device/Overview/Authorisation_Routes.html
For further queries on the regulatory framework and process for registration of medical devices in Singapore, please contact:
Health Sciences Authority
Medical Device Branch
Email: HSA_MD_Info@hsa.gov.sg
Phone: (65) 6866 1111
[Registration of Health Products > Medical Devices Enquiry]
Fax:  (65) 6478 9028
Or visit our website at: http://www.hsa.gov.sg
   

Annex: Class A medical devices exempted from product registration