Singapore

Medical Device Registration

Navigating Medical Device Registration in Singapore

Discover how to navigate the intricacies of Medical Device Registration in Singapore with our expert guidance. The Health Sciences Authority (HSA) oversees this critical process, ensuring compliance with local regulations. As a consulting partner, we assist the ‘Registrant’ in managing both the application submission and license holding responsibilities. Following this, registration with the Accounting and Corporate Regulatory Authority (ACRA) is mandatory for the local entity.

Our seamless process leverages the HSA’s online Medical Device Information and Communication System (MEDICS), providing a user-friendly platform for application submission. Once approved, a registration certificate is promptly issued, securing your place in the esteemed Singapore Medical Device Register (SMDR).

Ensure your medical device enters the Singapore market efficiently with our comprehensive support. Let’s start the journey towards compliance and market readiness. Contact us today to begin.

Medical Device Status

Per Singapore regulations, 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.

Registering Medical Devices in Singapore

Classification and Regulatory Pathways

The Health Sciences Authority (HSA) in Singapore closely follows GHTF guidelines to classify medical devices into Class A, B, C, and D, based on their risk levels, ranging from low to high. The diverse registration pathways available—Immediate, Expedited, Abridged, and Full—provide flexibility to accommodate varying device classifications.

For a swift registration process, the Immediate Route is accessible to Class B and C devices with registrations in 2 Reference Countries. On the other hand, the Abridged registration pathway caters to Class B, C, and D devices that have obtained registration in a single reference country. Devices without approvals from reference countries are mandated to undergo the comprehensive Full registration process.

Expedited Review Options

Here are the specifications and criteria for each registration pathway:

Immediate Route:
- Eligible Devices: Class B and C
- Criteria: Registration in 2 Reference Countries
Abridged Registration:
- Eligible Devices: Class B, C, and D
- Criteria: Registration in a single reference country
Full Registration:
- Eligible Devices: All classes
- Criteria: Comprehensive registration process for devices lacking approvals from reference countries

These pathways and their corresponding criteria exemplify the tailored approach that the HSA employs in Singapore’s Medical Device Registration, ensuring efficiency and accuracy in the classification and approval of devices.

Expedited Review Specifications

The specifications and criteria for each registration pathway are outlined as follows:

	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

In Singapore, the option for expedited review is available, contingent upon obtaining a minimum of 1 or 2 approvals from independent Reference Countries and maintaining robust safety records. The cost and duration of the regulatory review process vary significantly, influenced by both device classification and the extent of reference country registrations.

Notably, approvals from the EU (CE Marking) and the Australian Therapeutic Goods Administration (TGA) are considered qualifying, provided these approvals were obtained independently and not through the Mutual Recognition Agreement (MRA).

Standalone Software

For Standalone medical mobile applications categorized as Class C devices, eligibility for Immediate Registration (ICR) is established under specific conditions: a single Reference country approval, a clean safety record globally, and no previous rejections in Singapore. For additional details, refer to the HSA’s website here.

Expedited Review for Class C Devices

Expedited Review is an option extended to Class C devices meeting specific criteria, including approval from a single Reference country, a clean global safety record, and no history of rejection in Singapore. Furthermore, for Class C devices registered by 2 Reference Countries, an additional Expedited evaluation route, termed ECR-2, is available. Further details are accessible on the HSA’s website, referenced here.

It’s important to note that certain Class C devices are excluded from Expedited registration (ECR), including:

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

Expedited Review for Class D Devices

Expedited Review is an available option for Class D devices meeting specific criteria, which include approvals from 2 independent Reference countries, a global safety record without issues, and no prior rejections in Singapore. Additional details can be accessed on the HSA’s website here.

However, it’s crucial to note that certain Class D devices are excluded from Expedited registration (EDR), including:

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

For a comprehensive understanding of the exclusion criteria, the HSA has published a full list of registration guidance documents, which can be found here.

	Application Fee	Immediate Registration (IRB)	Expedited Registration (ECR)	Abridged Registration	Full Registration
Class A	n/a	n/a	n/a	n/a	n/a
Class B	S$560	S$1,000 Timeframe: 0 days	n/a	S$2,010 Timeframe: 100 days	S$3,900 Timeframe: 160 days
Class C	S$560	S$3,340 Timeframe: 0 days	S$3,180 Timeframe: 120 days	S$3,900 Timeframe: 160 days	S$6,250 Timeframe: 220 days
Class D	S$560	n/a	S$5,730 Timeframe: 180 days	S$6,250 Timeframe: 220 days	S$12,000 Timeframe: 310 day s
Class D (Drug)	S$560	n/a	n/a	S$10,600 Timeframe: 220 days	S$75,600 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$39, S$67 and S$134 for Class B, C and D devices, respectively.

Device Conformity Assessment and Documentation Requirements

For Class A devices, pre-market registration is not mandatory; however, licensed importers must annually list them with the HSA.

The HSA submission dossier follows the ASEAN CSDT (Common Submission Dossier Format). Required information varies based on device classification and the selected registration route. In addition to EU technical file documents, applications must include a Declaration of Conformity to the Essential Principles. Further details on documentation requirements in Singapore can be found in the HSA guidance document, GN-17 Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN CSDT, accessible here.

Quality Systems Conformity Assessment

Documentation for the quality system’s conformity assessment includes 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 highly transparent and predictable.

Reference Country Approval Requirement

Reference Country Approvals can significantly impact the registration pathway of Class B, C, and D devices. Acceptable Reference Countries include the USA, Canada, the EU, Australia, and Japan.

Maintaining Validity

Manufacturers, in coordination with their local license holder, are obligated by Singapore’s HSA to notify the authorities of any changes to the product before implementing them in Singapore. This is especially important for Software-only devices (SaMD) as version updates require notification prior to implementation. For additional details regarding Change Notifications, including associated fees and review timelines, you can find comprehensive information here.

Annual Retention (Renewal)

Registrations remain valid as long as annual listing fees are consistently maintained, and post-market vigilance requirements are satisfactorily fulfilled. The 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 in Singapore

A local agent or registrant must submit the registration application and hold the license. Additionally, a Licensed Importer needs an ISO 13485 and/or Good Distribution Practice Medical Device – Singapore (GDPMD-S) license and must be registered with the HSA for Customs clearance.

Transferring a Singapore Medical Device License

A local entity, serving as the license holder or Registrant, submits medical device registration applications and acts as the primary point of contact for the Health Sciences Authority (HSA) regarding the device listing.

The Health Products Act facilitates the transfer of the Registrant related to an active listing, with guidance provided in GN-24, Guidance on the Change of Registrant.

The HSA processes the Change of Registrant Application within 40 days, with a fee of S$820 (US$595). A single application may cover multiple medical device licenses, transferring from one relinquishing Registrant to a single accepting Registrant. Importantly, a Registrant change does not affect the annual listing fee, and the next payment date remains the anniversary date of the listing.

The relinquishing Registrant can retain responsibility for devices imported, or transfer it to the new Registrant. The transfer process mandates the relinquishing Registrant to sign a Declaration Form, permitting the transfer.

Benefits of Independent License Holding through Asia Actual

Maintain steady, reliable market access
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
“Navigating the Singapore medical device registration landscape can be challenging due to its diverse registration routes. Let Asia Actual guide you through the process with expertise and ease. ”

Contact Us

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

Singapore Medical Device Registration FAQs

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).

Singapore

Navigating Medical Device Registration in Singapore

Medical Device Status

Registering Medical Devices in Singapore

Classification and Regulatory Pathways

Expedited Review Options

Expedited Review Specifications

Expedited Review Options

Standalone Software

Expedited Review for Class C Devices

Expedited Review for Class D Devices

Device Conformity Assessment and Documentation Requirements

Quality Systems Conformity Assessment

Regulatory Efficiency

Reference Country Approval Requirement

Maintaining Validity

Annual Retention (Renewal)

License Holder Requirements in Singapore

Transferring a Singapore Medical Device License

Benefits of Independent License Holding through Asia Actual

Singapore Regulatory Support

Singapore Sales Support

Contact Us

Latest Market Updates

Singapore Medical Device Registration FAQs

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