2. Introduction
• Health Sciences Authority (HSA)
Regulatory authority that regulates medical device in the country
according to the Health Product Act and Health Product (Medical
Devices) Regulations
Under the Act and Regulations, all medical devices in the country must be
registered for approval prior to placement in the Singapore market, unless it
is stated otherwise that registration is not required.
3. Medical Device Registration
Medical device dealers must
be ACRA registered
Product Registration Dealer's License
• Company has to be registered with the Accounting and Corporate
Regulatory Authority (ACRA)
• Company may be product owner’s subsidiary office in Singapore or
local distributor/independent entity appointed by the product owner
to handle premarket submission and to address any inquiries raised by
the regulatory authority prior and after product approval
5. Medical Device Registration
“Medical Device” means any instrument, apparatus, implement, machine,
appliance, implant, in vitro reagent or calibrator, software, material or other
similar or related article that is intended by its manufacturer to be used,
whether alone or in combination, for humans for one or more of the specific
purposes of:
• Diagnosis, prevention, monitoring, treatment or alleviation of any disease;
• Diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
• Investigation, replacement, modification, or support of the anatomy or of a physiological
process;
• Supporting or sustaining life;
• Control of conception;
• Disinfection of medical devices; or
• Providing information for medical or diagnostic purposes by means of in vitro examination of
specimens derived from the human body,
and which does not achieve its primary intended action in or on the human
body by pharmacological, immunological or metabolic means, but which may
be assisted in its intended function by such means.
6. Medical Device Registration
Class A
Low Risk
Class B
Low-moderate
Risk
Class C
Moderate-high
Risk
Class D
High Risk
Medical Device Classification
All medical devices must be registered for approval prior to their placement in the
Singapore market.
Exception is reserved for Class A non-sterile medical devices, whereby product
registration is not required (they shall conform to the Essential Principles for Safety and
Performance for Medical Devices as stated in the Regulations)
For Class A sterile medical devices and medical devices of all other classes, application
for product registration is required.
7. Medical Device Registration
1 Full Evaluation
Route
A medical device that has yet been approved by any of the HSA’s reference regulatory agencies
(namely US FDA, the European Union, Japan’s Ministry of Health, Labour and Welfare (MHLW), Health
Canada and Australia’s TGA) will be subjected to the full evaluation route.
2 Abridged
Evaluation Route
A medical device that has been registered with at least one of HSA’s reference regulatory agencies
(namely US FDA, the European Union, Japan’s Ministry of Health, Labour and Welfare (MHLW), Health
Canada and Australia’s TGA) for a labeled use identical to that intended for marketing in Singapore is
eligible for abridged evaluation route.
3 Expedited
Evaluation Route
Class B and Class C devices (with the exception of hip, knee and shoulder joint replacement non bio-
active implants), which have been either approved by at least one referenced agency and marketed
for minimum of 3 years without safety issues, or approved by minimum of two referenced agencies.
Expedited registration is also available for Class D devices with exception of active implantable
devices, implantable devices in direct contact with central circulatory/nervous system, hip, knee and
shoulder joint replacement, drug incorporating devices in ancillary role and IVD devices for HIV and
blood/tissue donor compatibility testing.
4 Immediate
Evaluation Route
Class B devices which have been approved by at least two independent referenced agencies without
prior rejection or withdrawal on registration and marketed for minimum of 3 years without safety
issues.
Medical Device Evaluation Route
8. Medical Device Registration
Risk Class Application Fees Evaluation Fees
Immediate Expedited Abridged Full
Class A (Non-Exempt) $25 - - - -
Class B $500 $900 $900 $1,800 $3,500
Class C $500 - $3,000 $3,500 $5,700
Class D $500 - $5,400 $5,700 $11,400
Class D, devices
incorporating medicinal
products
$500 $10,000 $75,000
Risk Class TAT for Registration (Working Days)
Class A (Sterile) 30
Immediate Expedited Abridged Full
Class B Immediate Registration upon
Submission
60 100 160
Class C - 120 160 220
Class D - 180 220 310
Class D, devices
incorporating medicinal
products
220 310
