HSA SMDR

MEDICAL DEVICE REGISTRATION IN SINGAPORE

GOVERNMENT AUTHORITY

Medical device product registration in Singapore is overseen by the Health Sciences Authority (HSA), before being imported and placed on the market.  When applying for product registration in Singapore, applications must be submitted by a local entity that also acts as license holder, or Registrant. The Singapore-based entity must be registered with the Accounting and Corporate Regulatory Authority (ACRA) of Singapore. Medical device registration processing is conducted through the HSA online Medical Device Information and Communication System (MEDICS). Successful applications will generate a registration certificate and a listing on the Singapore Medical Device Register (SMDR)

MEDICAL DEVICE STATUS

In Singapore, a medical device is any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for the purpose of  diagnosis, prevention, monitoring, treatment or alleviation of disease or injury. 

PRODUCT CLASSIFICATION

The HSA closely follows GHTF guidelines for medical device classification with Class A, B, C and D devices ranging from low to high risk. In Singapore, there are four different registration pathways. Class B, C and D devices that are registered in one reference country are eligible to apply for the Abridged registration. Devices without reference country approvals are subject to the Full registration process.

Requirements for the different registration pathways:

Immediate RegistrationExpedited RegistrationAbridged RegistrationFull Registration
Class An/an/an/an/a
Class B1 Reference Country with Identical label
+ 3 years in Reference country
+ No safety issues globally
+No prior rejection in SingaporeORApproval by 2 Reference Countries
+ No safety issues globally
+ No prior rejection in Singapore
n/a1 Reference Country’s approvalNo Reference Country approval
Class Cn/a1 Reference Country’s approval
+ 3 years in Reference country
+ No safety issues globally
+No prior rejection in SingaporeOR2 Reference countries
+ No prior rejection in Singapore
1 Reference Country’s approvalNo Reference Country approval
Class Dn/a2 Reference Countries’ approval
+ No prior rejection in Singapore
1 Reference Country’s approvalNo Reference Country approval

Click the following links to learn more classifying and grouping your devices in Singapore

See also  Are supplements HSA approved?

Expedited Review Options

Class C devices that are Standalone medical mobile applications qualify for an Immediate Registration (ICR): with 1 Reference country, no safety issues globally and no prior rejection in Singapore

Class C devices excluded from the Expedited registration (ECR):

  • Hip, knee and shoulder joint replacement
  • Non-bio-active implants. 

Class D devices excluded from the Expedited registration (EDR):

  • Active Implantable devices
  • Implantable devices connected circulatory system or central nervous system
  • Hip, knee, and shoulder joint replacement (bio-active implants)
  • Devices incorporating a registrable drug in an ancillary role
  • IVD devices for HIV
  • Blood/tissue donor compatibility

Cost and time for regulatory review will vary considerably with device classification and reference country registrations.

Immediate Registration (IRB)Expedited Registration (ECR)Abridged RegistrationFull Registration
Class An/an/an/an/a
Class BUS$ 635
Timeframe: 0 days
n/aUS$1,265
Timeframe: 100 days
US$2,465 Timeframe: 160 days
Class Cn/aUS$2,110
Timeframe: 120 days
US$2,465
Timeframe: 160 days
US$4,010
Timeframe: 220 days
Class Dn/aUS$3,800 Timeframe: 180 daysUS$4,010 Timeframe: 220 daysUS$8,020 Timeframe: 310 day s
Class D (Drug)n/an/aUS$7,035
Timeframe: 220 days
US$52,750 Timeframe: 310 days

In addition to the application processing fee, the HSA also charges a one-time application fee of S$500 for all classifications of devices.  There is also an annual listing fee of S$35, S$60 and S$120 for Class B, C and D devices respectively.

DEVICE CONFORMITY ASSESSMENT

Class A devices do not require pre-market registration, but must be listed with the HSA on an annual basis by the licensed importer.  

The HSA submission dossier  is based on the ASEAN CSDT (Common Submission Dossier Format). The required information varies based on the device classification and available registration route. In addition to documents required by the EU technical file, applications require a Declaration of Conformity to the Essential Principles.

See also  HSA Approved Products

QUALITY SYSTEMS CONFORMITY ASSESSMENT

Quality systems conformity assessment must be documented with ISO 13485 or an audit report from the FDA (e.g., Establishment Inspection Report) or Japanese PMDA.

REGULATORY EFFICIENCY

The Singapore medical device registration process is considered highly transparent and predictable.

REFERENCE COUNTRY APPROVAL REQUIREMENT

Reference Country Approvals can significantly influence the registration pathway of Class B, C and D devices. The following countries are acceptable Reference Countries.

REFERENCE COUNTRIES

Australia – Canada – European Union – Japan – United States