IVD Device Registration in Singapore

IVD product registration in Singapore is overseen by the Health Sciences Authority (HSA), before devices can be imported and placed on the market.  The registration process is considered highly transparent and predictable.  Applications must be submitted by a local entity that also acts as license holder, or Registrant.  The HSA closely follows GHTF guidelines for IVD device classification.  Cost and time for regulatory review will vary considerably with device classification and reference country registrations/approvals.

Class A IVD devices do not require pre-market registration, but must be listed with the HSA on an annual basis by the licensed importer.  However, sterile Class A IVD devices must be registered with the HSA.  The application fee is S$25 and processing time is 30 working days.

Class B IVD devices that have been registered in two reference countries for more than three years each without any “safety concerns” qualify for Immediate Registration (IBR).  HSA (application and evaluation) fees total $1,400 and processing time is 0 working days.  Class B IVD devices that have been registered in two reference countries, or one reference country for more than three years without any “safety concerns” qualify for Expedited Registration (EBR).  HSA (application and evaluation) fees total $1,400 and processing time is 60 working days.  Class B IVD devices that have been registered in one reference country qualify for Abridged Registration.  HSA (application and evaluation) fees total $2,300 and processing time is 100 working days.  All other Class B IVD devices undergo a Full Registration process.   HSA (application and evaluation) fees total $4,000 and processing time is 160 working days.

Class C IVD devices that have been registered in two reference countries, or one reference country for more than three years without any “safety concerns” qualify for Expedited Registration (ECR).  HSA (application and evaluation) fees total $3,500 and processing time is 120 working days.   Class C IVD devices that have been registered in one reference country qualify for Abridged Registration.  HSA (application and evaluation) fees total $4,000 and processing time is 160 working days.  All other Class C IVD devices undergo a Full Registration process.   HSA (application and evaluation) fees total $6,200 and processing time is 220 working days.

Class D IVD devices that have been registered in two reference countries, or one reference country for more than three years without any “safety concerns” qualify for Expedited Registration.  HSA (application and evaluation) fees total $6,100 and processing time is 180 working days.   Class D IVD devices that have been registered in one reference country qualify for Abridged Registration.  HSA (application and evaluation) fees total $6,300 and processing time is 220 working days.  All other Class D IVD devices undergo a Full Registration process.   HSA (application and evaluation) fees total $11,900 and processing time is 310 working days.

Contact Asia Actual for assistance to confirm the cost and time lines that apply to your  IVD products.  Asia Actual also has experienced, top level consultants in Singapore to manage the application process.