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Medical device registration in Singapore is overseen by the Health Sciences Authority (HSA). Medical device applications are submitted by a local entity that also acts as the license holder, locally referred to as the ‘Registrant.’ The Singapore-based entity will need to be registered with the Accounting and Corporate Regulatory Authority (ACRA) of Singapore. The medical device registration process is conducted through the HSA online Medical Device Information and Communication System (MEDICS). Successful applications will generate a registration certificate and listing on the Singapore Medical Device Register (SMDR).
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.
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, Immediate, Expedited, Abridged, and Full. Class B and C devices registered in 2 Reference Countries are eligible for the Immediate Route while Class B, C and D devices that are registered in one reference country are eligible for the Abridged registration. Devices without reference country approvals are subject to the Full registration process.
Requirements for the different registration pathways:
Immediate Registration | Expedited Registration | Abridged Registration | Full Registration | |
Class A | n/a | n/a | n/a | n/a |
Class B | 1 Reference Country with Identical label + 3 years in Reference country + No safety issues globally +No prior rejection in Singapore OR Approval by 2 Reference Countries | n/a | 1 Reference Country’s approval | No Reference Country approval |
Class C | Standalone medical device mobile software app + 1 Reference Country with Identical label + 3 years in Reference country + No safety issues globally +No prior rejection in Singapore | 1 Reference Country’s approval + 3 years in Reference country + No safety issues globally +No prior rejection in Singapore OR 2 Reference countries | 1 Reference Country’s approval | No Reference Country approval |
Class D | n/a | 2 Reference Countries’ approval + No prior rejection in Singapore | 1 Reference Country’s approval | No Reference Country approval |
Click the following links to learn more classifying and grouping your devices in Singapore
Expedited review options are available in Singapore and require at least 1 or 2 approvals from independent Reference Countries and strong safety records. Cost and time for regulatory review will vary considerably with device classification and reference country registrations. Approvals from the EU (CE Marking) and the Australian TGA will qualify if the applications were approved independently and not through the Mutual Recognition Agreement (MRA).
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. More information is found on the HSA’s website here.
Expedited Review is available to Class C devices with 1 Reference country, no safety issues globally and no prior rejection in Singapore. For Class C devices registered by 2 Reference Countries, there is an additional Expedited evaluation route 2 (ECR-2). More information is found on the HSA’s website here.
Class C devices excluded from the Expedited registration (ECR):
Expedited Review is available to Class D devices with 2 independent Reference country, no safety issues globally and no prior rejection in Singapore. More information if found on the HSA’s website here.
Class D devices excluded from the Expedited registration (EDR):
A full list of registration guidance documents published by the HSA is found here.
Immediate Registration (IRB) | Expedited Registration (ECR) | Abridged Registration | Full Registration | |
Application Fee | S$530 (US$415) | S$530 (US$415) | S$530 (US$415) | S$530 (US$415) |
Class A | n/a | n/a | n/a | n/a |
Class B | S$950 (US$750)
Timeframe: 0 days | n/a | S$1,910 (US$1,500)
Timeframe: 100 days | S$3,710 (US$2,925)
Timeframe: 160 days |
Class C | S$3,180 (US$2,500)
Timeframe: 0 days | S$3,180 (US$2,500)
Timeframe: 120 days | S$3,710 (US$2,925)
Timeframe: 160 days | S$6,050 (US$4,775)
Timeframe: 220 days |
Class D | n/a | S$5,730 (US$4,520)
Timeframe: 180 days | S$6,050 (US$4,775)
Timeframe: 220 days | S$11,800 (US$9,312)
Timeframe: 310 day s |
Class D (Drug) | n/a | n/a | S$10,400 (US$8,200)
Timeframe: 220 days | S$75,400 (US$59,500)
Timeframe: 310 days |
*HSA updated their fees on July 1, 2022 and more information can be found here.
In addition to the application processing fee, the HSA also charges a one-time application fee of S$530 (USD$410) for all classifications of devices. There is also an annual listing fee of S$37, S$64 and S$128 for Class B, C and D devices, respectively.
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. More information on the Singapore documentation requirements can be found here in the HSA guidance document: GN-17 Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN CSDT.
The quality system’s conformity assessment is documented with ISO 13485 or an audit report from the FDA (e.g., Establishment Inspection Report) or Japanese PMDA.
The Singapore medical device registration process is considered highly transparent and predictable.
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 include the USA, Canada, the EU, Australia, and Japan.
As long as annual listing fees are maintained, and post market vigilance requirements are met, registrations do not expire. Annual retention fees are as follows:
A local agent or registrant will need to submit the registration application and hold the license. Additionally, a Licensed Importer is needed for Customs clearance. The Licensed Importer requires an ISO 13485 and/or Good Distribution Practice Medical Device – Singapore (GDPMD-S) license and registered with the HSA.
Medical device registration applications are submitted by a local entity that also acts as license holder, or Registrant. The Registrant is the key point of contact for the Health Sciences Authority (HSA) regarding the device listing.
The Health Products Act provides for the transfer of Registrant related to an active listing. Guidance is provided in GN-24, Guidance on the Change of Registrant.
The Change of Registrant Application is processed by the HSA in 40 days at a fee of S$820 (US$595). One application may cover multiple medical device licenses (from one relinquishing Registrant to a single accepting Registrant). The annual listing fee is not affected by a Registrant change. The next payment date will remain the anniversary date of the listing.
Responsibility for devices imported under the relinquishing Registrant are e retained by the relinquishing Registrant or transferred to the new Registrant. The transfer process requires a Relinquishing Company Declaration Form executed by the incumbent Registrant, among other documents.
Contact Asia Actual for assistance to confirm the cost and time lines that apply to your medical devices. Asia Actual has experienced, top level consultants in Singapore to help you manage the application process.
Kenna Rasiklal Principal Consultant, Asia Actual Singapore
Kenna’s Regulatory Hint
“Singapore can be a difficult market to navigate, because of the varied registration routes. Asia Actual can help. ”
US: +1 512 898-9222
SG: +65 8800-3197
EMAIL: inquiry@asiaactual.com
Who can submit submit applications in Singapore?
A local entity, called a Registrant, must submit applications, hold the license, and correspond with the Health Science Authority (HSA).
How are products classified in Singapore?
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.
How long does it take to register my medical device in Singapore?
Registration timelines in Singapore are largely dependent on whether the product is registered in one or more reference countries. Products registered in either more than 1 reference country or 1 reference country with 3 years of safety will experience the quickest registration.
More information on Singapore’s registration timelines, please click here.
How much does it cost to register my device in Singapore?
Registration fees in Singapore depend on the registration route which relies on the product’s approval history.
How long are medical device licenses valid in Singapore?
As long as annual listing fees are maintained, and post market vigilance requirements are met, registrations do not expire.
Annual retention fees in Singapore are as follows and paid by the local Registrant:
Does the license holder need to import the products?
No, license holders do not need import the licensed products and manufacturers can work directly through their distributor.
Is there an expedited review pathway?
Yes, there are expedited review pathways for Class B, C, and/or D depending on the following criteria:
1 Reference Country’s approval + 3 years in Reference country + No safety issues globally +No prior rejection in Singapore
OR
2 Reference countries + No prior rejection in Singapore
Expedited Review Routes include the following:
Is ISO 13485 required for medical devices in Singapore?
Yes, ISO 13485 is required for registration in Singapore.
Is Home Country approval required?
No, home country approval is not required but Reference country approval will significantly improve the review time.
Do I need to translate any documents as part of the application process?
No, application documents are submitted in English and there are no additional requirements for labeling or Instructions for Use (IFUs).
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