Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Class B device registration, abridged evaluation (Abridged evaluation route)

Singapore · Health Sciences Authority · Medical devices

Reliance route, abridged reviewHigh confidenceLast verified October 3, 2026

Review target

100 working days

performance goal

Legal time limit

Not published

Steps

8 requirements

What is the Class B device registration, abridged evaluation in Singapore?

For a Class B device approved for the same labeled use by at least one of the agency's reference regulators, or registered in Malaysia under the reliance program. The target is 100 working days from receipt of the application, without stop-clock time. A Class B device with a qualifying approval in Australia, Canada, the EU, Japan, the United States or Malaysia.

How long does the Class B device registration, abridged evaluation take?

The official review target is 100 working days (performance goal). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.

How much does the Class B device registration, abridged evaluation cost?

The evaluation fee, class b, abridged route is SGD 2,010 for Fee list updated 26 March 2026.

What are the steps of the Class B device registration, abridged evaluation?

1. Online application; 2. Screening; 3. Evaluation (100 days); 4. Input request (clock stopped); 5. Decision and listing.

Does the Class B device registration, abridged evaluation rely on other regulators?

Yes. It relies on approvals from Australia, Canada, European Union, Japan, Malaysia, United States (shorter review, shorter review, shorter review, shorter review, shorter review, shorter review).

Outcome: Listing on the Singapore Medical Device Register. A yearly retention fee keeps the listing.

Legal basis: Health Products Act 2007; Health Products (Medical Devices) Regulations 2010

Steps

In order, with the official target for each step

1. Online applicationFiled online. The application fee is charged at filing.
2. ScreeningThe agency checks eligibility for the route and completeness. The evaluation fee is charged at acceptance.
3. Evaluation100 working daysTarget: 100 working days counted from receipt of the application, without stop-clock time.
4. Input request (clock stopped)clock stopped, only in some casesThe clock stops until a complete and satisfactory answer arrives.
5. Decision and listingApproved devices are listed on the Singapore Medical Device Register after payment.

Requirements

What the applicant must provide or meet

Other

Dossier format: ASEAN CSDTThe dossier follows the ASEAN Common Submission Dossier Template. The software device guidance also allows the IMDRF table of contents format.

Language

Documents in EnglishAll documents are in English.

Quality system

Quality management system proofProof of at least one quality system: ISO 13485, MDSAP, US FDA quality system rules, or Japan MHLW Ordinance 169.

Clinical evaluation

Preclinical summaries and clinical evaluation report if applicableSummaries of preclinical studies, including sterilization and shelf-life studies where relevant, and a clinical evaluation report where applicable. More clinical data may be requested for labeled uses beyond normal use.

Local presence

Letter of authorization from the product ownerThe product owner authorizes the registrant to apply on its behalf. Importers and suppliers need a dealer's licence.

After approval

Adverse event reportingReport within 48 hours for a serious threat to public health, 10 days for a death or serious deterioration, and 30 days for an event that could cause one if it happened again.
Change notification and yearly retentionChanges to a registered device are notified to the agency. A yearly retention fee keeps the listing; a listing is cancelled if the fee is not paid within 60 days after the due date.

Reference approval

One reference approval for the same labeled useApproval from at least one reference regulator (TGA, Health Canada, Japan MHLW, US FDA or an EU notified body), or registration in Malaysia under the reliance program, for the same labeled use. Approvals as Class I or Class II exempt abroad do not count.

Fee	Amount
Evaluation fee, Class B, abridged routeApplication · Fee list updated 26 March 2026	SGD 2,010

Reliance on other regulators

AustraliaShorter review, target 100 daysApproval for the same labeled use. Approvals as Class I or Class II exempt abroad do not count.
CanadaShorter review, target 100 daysApproval for the same labeled use. Approvals as Class I or Class II exempt abroad do not count.
European UnionShorter review, target 100 daysApproval for the same labeled use. Approvals as Class I or Class II exempt abroad do not count.
JapanShorter review, target 100 daysApproval for the same labeled use. Approvals as Class I or Class II exempt abroad do not count.
MalaysiaShorter review, target 100 daysDevice registered with Malaysia's Medical Device Authority after full conformity assessment by a recognized conformity assessment body, for the same labeled use. Not for devices with a medicinal product or devices classified differently by the two agencies.
United StatesShorter review, target 100 daysApproval for the same labeled use. Approvals as Class I or Class II exempt abroad do not count.

Rule changes

Device reliance on Malaysia's Medical Device AuthorityIn force, March 10, 2026, effective March 10, 2026

Class B device registration, abridged evaluation (Abridged evaluation route)

What is the Class B device registration, abridged evaluation in Singapore?

How long does the Class B device registration, abridged evaluation take?

How much does the Class B device registration, abridged evaluation cost?

What are the steps of the Class B device registration, abridged evaluation?

Does the Class B device registration, abridged evaluation rely on other regulators?

How the pathway works

Timeline with clock stops

Steps

Requirements

Other

Language

Quality system

Clinical evaluation

Local presence

After approval

Reference approval

Official time targets

Fees

Reliance on other regulators

Rule changes