Singapore

Medical Device Registration in Singapore

Government Authority: The Health Sciences Authority (HSA)

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).

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.

Classification and Regulatory Pathways

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 + No safety issues globally + No prior rejection in Singapore	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 + No prior rejection in Singapore	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

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).

Standalone Software

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 for Class C Devices

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):

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

Expedited Review for Class D Devices

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):

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

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.

Device Conformity Assessment and Documentation Requirements

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.

Quality Systems Conformity Assessment

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.

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 include the USA, Canada, the EU, Australia, and Japan.

Validity and Renewal

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:

Class B: (SG$37/US$30)
Class C: (SG$64/US$51)
Class D: (SG$128/US$102)

License Holder Requirements

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.

License Transfer

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.

Benefits of Independent License Holding through Asia Actual

Sell directly to multiple regional distributors, avoiding mark-up by a national importer
Increase transfer pricing
Improve leverage in distributor negotiations/responses
Add or change distributors as required
Keep intellectual property away from local commercial agents
Assure expert handling of post market vigilance and license maintenance

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. ”

Contact Us

US: +1 512 898-9222
SG: +65 8800-3197
EMAIL: inquiry@asiaactual.com

Frequently Asked Questions

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.

Class A are immediately listed
Class B will range from immediate to 160 working days for full registration
Class C will range from 120 days to 220 days
Class D will range 180 to 310 days
Class D with drugs will range from 220 to 310 days.

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.

Class A are free to list.
Class B costs between US$635 and US$2,465.
Class C costs between US$2,110 and US$4,010.
Class D costs between US$3,800 and US$8,020
Class D with a drug costs between US$7,035 and US$52,750

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:

Class A: US$27
Class B: US$46
Class C: US$91
Class D: US$91

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

2 Reference countries + No prior rejection in Singapore

Expedited Review Routes include the following:

Immediate: available to Class B
Expedited available to Class C and D
Abridged available to Class B, C, and D

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).