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HSA · South & Southeast Asia

Singapore medical device regulatory resources

Every Singapore dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

20,860 registration records11 free resources25/25 requirements covered71 regulations trackedAug 2026 fees reviewed
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Medical device registration database

Search official HSA device registration records.

Medical device registry insights

Explore market trends, registrations, manufacturers, and local representatives.

Medical device regulations

Browse official HSA regulations and guidance documents.

Registration timeline

Compare official and realistic approval times by device class and pathway.

Government registration fees

Review current HSA application, review, and renewal fees.

AI registration cost and timeline planner

Estimate the likely HSA pathway, government fees, dossier preparation time, review timeline, and registration steps.

Medical device regulation news

Follow recent HSA policy, guidance, and compliance updates.

AI medical device classifier

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Additional certification and licence checker

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AI similar registered product finder

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Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Structured regulatory requirements

Explore all 56 source-linked facts →

25 of 25 research dimensions currently covered · 32 official sources · latest verification 2026-09-07

Market entry

D01

Authority & regime

Verified
Competent authority
The Health Sciences Authority (HSA) is 'the Authority' that administers the Health Products Act 2007 and the Health Products (Medical Devices) Regulations 2010 for medical devices.
1 source-linked fact
Checked 2026-08-25
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D02

Legal basis & guidance

Verified
Primary legislation and principal regulations
Medical devices are regulated under the Health Products Act 2007 and the Health Products (Medical Devices) Regulations 2010 (S 436/2010, current as at 26 Aug 2026, latest amended by S 809/2…
1 source-linked fact
Checked 2026-08-25
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D03

Device definition & scope

Verified
Medical device definition and scope
A 'medical device' means a medical device referred to in the First Schedule to the Health Products Act; in vitro diagnostic products are separately defined in reg 2 of the Medical Devices R…
1 source-linked fact
Checked 2026-08-25
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D04

Classification rules

Verified
Risk classes A through D for general devices and IVDs.
Class A, Class B, Class C, Class D
1 maintained scheme
Checked 2026-08-25
Open details →
D05

Registration pathways

Verified
Prohibition on supply of unregistered devices
A person must not supply a health product (device) unless it is registered, except in prescribed cases; contravention is punishable by fine up to $50,000 and/or imprisonment up to 2 years.
Class A exemption and product notification
Class A medical devices are exempt from product registration (reg 10B) but must be notified to HSA via a product notification application in SHARE (Class A database) before supply.
3 source-linked facts
Checked 2026-08-25
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D06

Reliance & recognition

Verified
Australia TGA reference approval
TGA (Australia) is one of HSA's overseas reference regulatory agencies; its prior approval qualifies a device for Abridged, and with marketing history or a second approval for Expedited/Imm…
EU notified body certificates (MDR/IVDR and directives)
EU notified body certificates qualify as reference approvals: MDR Annex IX/XI A, IVDR Annex IX, and legacy directive certificates (93/42/EEC, 98/79/EC) as specified on HSA's registration ov…
5 source-linked facts
Checked 2026-08-25
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D07

Economic-operator roles

Verified
Local registrant and licence holder
Registration and dealer's licences are held by Singapore registered entities identified by their ACRA issued UEN; foreign manufacturers place devices through a local registrant, and the sam…
Change of registrant process
Changing the registrant of a registered device is a formal application under GN 24 (R2, 2025) submitted via SHARE; the current fee is S$880 with a 40 working day turnaround.
2 source-linked facts
Checked 2026-08-25
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D08

Establishment, import & distribution

Verified
Dealer's licence requirement
A dealer's licence is required to manufacture, import or wholesale medical devices in Singapore (HPA ss 12 14); unlicensed activity carries fines up to $50,000 and/or 2 years' imprisonment…
Licence issue requirements (QMS/GDP)
Manufacturer's licence requires ability to comply with ISO 13485 (reg 2A); importer's and wholesaler's licences require ability to comply with the Good Distribution Practice Standard for Me…
4 source-linked facts
Checked 2026-08-27
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D09

Dossier requirements

Verified
Registration approval standard
Registration requires that the device's overall intended benefits to the end user outweigh the overall risks, and that based on conformity with the safety and performance requirements publi…
Dossier format: ASEAN CSDT
Registration submissions are prepared in the ASEAN Common Submission Dossier Template format per GN 17/GN 18 (R4, Oct 2025) and submitted electronically; HSA also publishes an E Submission…
2 source-linked facts
Checked 2026-08-25
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D10

Official forms & portals

Verified
SHARE e-service portal
SHARE is HSA's online portal for device transactions: new product registration, change notification, change of registrant, withdrawal, fulfilment of approval conditions, cancellation, Class…
Prescribed adverse-event report forms
Adverse event reports must use Form MDAR1 for events not related to a clinical trial, and Form CTB MD AE for events related to a clinical trial (submitted to the Clinical Trials Branch). Su…
2 source-linked facts
Checked 2026-08-27
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Submission & evidence

D11

Label, IFU & language

Verified
Information to accompany devices
Devices must be supplied with the information specified in reg 15, including an appropriate control number such as a batch code, lot number or serial number, and statements such as 'For Cli…
English labelling requirement
All information on the label of a medical device must be provided in English and may in addition be provided in any other language (reg 16(2)).
3 source-linked facts
Checked 2026-08-27
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D12

QMS, audit & inspection

Verified
Accepted QMS evidence
Manufacturers must maintain a QMS conforming to ISO 13485; Class B/C/D manufacturers need ISO 13485 certification by SAC accredited certification bodies, and MDSAP certification is accepted…
1 source-linked fact
Checked 2026-08-25
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D13

Standards, testing & ancillary approvals

Verified
HSA electrical/EMC evidence
Electrical safety
IMDA ESER/SER/GER equipment registration
Wireless / radio
NEA radiation licence
Radiation
3 maintained overlays
Checked 2026-09-07
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D15

Review clocks

Verified
Class A · Notification
Immediate
Class B · IBR/Expedited/Full Route
0-160 working days
Class C · IBR/Expedited/Full Route
0-220 working days
4 maintained pathways · 1 related fact
Checked 2026-08-30
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D16

Approval validity & renewal

Verified
Registration duration
Device registration remains in force indefinitely so long as the registrant continues to pay the prescribed annual retention fee within the prescribed time and the registration is not suspe…
Lapse for non-payment
Registration is cancelled if the retention fee is not paid within the prescribed time, which is 60 days after the anniversary of the date of registration (reg 26A, for the purposes of s 37(…
3 source-linked facts
Checked 2026-08-25
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Lifecycle & post-market

D17

Change control

Verified
Change control outcomes
GN 21 classifies changes into approval requiring changes (technical changes to Class C and D devices; review changes for Class B), notification changes, and administrative changes (6Aii/6Ai…
Triggers for new registration instead of change notification
A new registration application (not a change notification) is required for: change in risk classification, change in intended use of the device, addition of a model that does not fulfil the…
3 source-linked facts
Checked 2026-08-25
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D18

UDI, listing & traceability

Verified
UDI system guidance and data submission
HSA publishes GN 36 R2 Guidance on the Medical Device UDI System (July 2022); UDI implementation requirements and submission of UDI information into the SMDR and Class A Medical Device Data…
UDI must appear in HRI and AIDC
The UDI on the label or on the device itself and on all higher levels of device packaging must be presented in both human readable interpretation (HRI) format and AIDC forms such as linear…
3 source-linked facts
Checked 2026-08-27
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D19

Clinical investigation & performance

Verified
Clinical research supply exception and use limits
Unregistered devices may be supplied where the planned use is a clinical purpose in clinical research (reg 10A), with prior notice to the Authority under reg 51 from the manufacturer; such…
Clinical research sponsor duties
Sponsors must ensure devices in clinical research are used only for the clinical purpose and, where the research requires institutional review board approval, with that approval; unused dev…
3 source-linked facts
Checked 2026-08-27
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D20

Special access & derogation

Verified
Custom-made and laboratory-developed test exception
Custom made medical devices and laboratory developed tests are exempt from the registration prohibition under reg 6, subject to the conditions in that regulation (manufacture exceptions in…
Emergency medical devices exception
Emergency medical devices may be manufactured, imported and supplied without registration under reg 13C where the Minister designates the device for Government use and the Authority is sati…
3 source-linked facts
Checked 2026-08-25
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D21

Manufacturer PMS

Verified
Complaint records duty
Manufacturers, importers, wholesalers, registrants and persons supplying unregistered devices under the regulations must maintain a record of every complaint received pertaining to the devi…
15-day adverse information reporting
Every licensee and registrant must inform the Authority within 15 days of receiving any information which adversely affects the validity of data furnished to the Authority relating to the q…
2 source-linked facts
Checked 2026-08-25
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D22

Vigilance & incident reporting

Verified
Who must report adverse events
All companies dealing in medical devices importers, manufacturers, suppliers and registrants must report adverse events of their products, whether registered or unregistered; reports are ma…
48-hour reporting clock (serious public health threat)
Defects or adverse effects that may seriously threaten public health must be reported to the Authority within 48 hours.
5 source-linked facts
Checked 2026-08-25
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D23

Recall, FSCA & market surveillance

Verified
24-hour recall pre-notification
A manufacturer, importer, supplier or registrant who intends to recall a device must notify the Authority of the intended recall at least 24 hours before the time of the intended recall; th…
FSCA pre-notification
A manufacturer must notify the Authority of the intended field safety corrective action before carrying out any FSCA; the Authority may require a public statement; offences up to $10,000/6…
4 source-linked facts
Checked 2026-08-27
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D24

Advertising, claims & promotion

Verified
Advertisement restrictions
Advertisements must not contain statements that expressly or implicitly suggest the device's use is promoted or endorsed by the Authority (statements of registration and the registration nu…
Restriction on advertising for specified diseases
Advertisements promoting medical devices for diseases and conditions specified in the Second Schedule are restricted (reg 22; only distribution to qualified practitioners, pharmacists, nurs…
3 source-linked facts
Checked 2026-08-27
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D25

Submission communications & appeal

Verified
Appeal to the Minister
Persons affected by HSA decisions refusal of registration (s 30), imposition of conditions (s 32), reclassification (s 36), suspension or cancellation (s 37) may appeal in writing to the Mi…
1 source-linked fact
Checked 2026-08-25
Open details →

Government fees

Full fee schedule (37 lines) →

HSA registration fees in SGD · reviewed 2026-08-25

Fee lineAmountProvenance
Class A Product RegistrationSGD 0Verified
Application Fee - Class B/C/DSGD 560Verified
Evaluation - Immediate (Class B)SGD 1,000Verified
Evaluation - Abridged (Class B)SGD 2,010Verified
33 more fee lines on the full schedule · 37 of 37 rows source-verified

Registration timeline

Full registration timeline →

Health Sciences Authority (HSA) review clocks and planning ranges · 4-class (A, B, C, D) classification

Class / pathwayReview clockPlanning totalProvenance
Class A(Notification)ImmediateImmediateVerified
Class B(IBR/Expedited/Full Route)0-160 working days3-9 monthsVerified
Class C(IBR/Expedited/Full Route)0-220 working days6-12 monthsVerified
Class D(IBR/Expedited/Full Route)180-310 working days9-18 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(Immediate)
  5. 5Registration Approval(1-2 weeks)

Latest regulation news

All Singapore regulation news →

Newest official HSA headlines from the daily-refreshed feed — every row links directly to the authority publication.

Aug 28HSHealth Sciences AuthorityHSA Announces Registration Support Initiative for Unregistered Medical DevicesSingaporeAug 14HSHealth Sciences AuthorityHSA Summary of Responses on Medical Device Cybersecurity Best Practices GuideSingaporeJul 17HSHealth Sciences AuthorityRecall of BD ChloraPrep 1 mL Applicator - Clear (17 July 2026)SingaporeSep 03, 25HSHealth Sciences AuthorityArchived Regulatory GuidancesSingaporeSep 03, 25HSHealth Sciences AuthorityGN-08-R2 Guidance on Medical Device Advertisements and Sales PromotionSingapore

Key regulations

All 71 Singapore regulations →

Official HSA rules and guidance · 71 of 71 documents linked to official sources

Act 15 of 2007 (2020 Rev Ed)Health Products Act 2007
GeneralVerified
S 436/2010Health Products (Medical Devices) Regulations 2010
GeneralVerified
S 450/2022Health Products (Fees) Regulations 2022
RegistrationVerified
HSA Medical DevicesHealth Sciences Authority - Medical Devices Overview
GeneralVerified

Registry insights

Full registry statistics →

Computed from 20,860 official HSA registration records · data as of 2026-08-21

New registrations by year
2020202120222023202420252026
VerifiedHSA registry · as of 2026-08-21
20,860
Registrations
4,190
Product Owners
870
Registrants
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Singapore dossier reuse and delta

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Singapore change notification workpaper

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Singapore regulatory change impact

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Singapore cybersecurity evidence review

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