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Singapore medical device regulations

Official sources linked

HSA rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.

71 documents9 categories100% linked to official sourcesauthority HSA66 readable HTML
CodeRegulationCategoryEffectiveProvenance
GN-15
Guidance on Medical Device Product Registration
HSA GN-15 Revision 13 (March 2026) product-registration guidance. Linked from the official HSA guidance-documents page. The previous default-source URL returned 404.
RegistrationMarch 2026Official
S 450/2022
Health Products (Fees) Regulations 2022
Prescribed-fee schedule for all Health Products Act regimes, ingested as the official informal consolidation in force from 1 July 2024 (incorporating S 833/2023). Regulations 1–5 (fees payable, time for payment, waiver or refund) plus all nine Schedules are in the corpus; the Sixth Schedule carries every medical-device fee as its own searchable item — registration application ($560), evaluation by class and process (e.g. Class B abridged $2,010, Class D full $12,000, drug-device combination full $75,600), annual retention ($39/$67/$134 by class), licence and variation fees.
RegistrationJuly 1, 2022Official
S 436/2010
Health Products (Medical Devices) Regulations 2010
Core medical-device subsidiary legislation made under sections 45, 71 and 72 of the Health Products Act, ingested as the official informal consolidation in force from 18 December 2023 (latest amendment S 809/2023). All 79 regulation blocks across Parts I–X are in the corpus — licensing (regs 2A–2B), licence exceptions (Part II), supply and wholesaling (Part III), emergency-use exception (Part IIIA), labelling and advertisements (Parts IV–V), registration and evaluation (Part VI, including the reg 26 evaluation processes and reg 26A cancellation-for-non-payment rule), export certification (Part VII), and duties of licensees/registrants (Part VIII) — with regulation 2 definitions split per term and the Third Schedule risk-classification criteria reproduced. Numbering gaps (no reg 50; the deleted stubs 27–29 and deleted Parts/Schedules) mirror the official consolidation.
GeneralAugust 10, 2010Official
Act 15 of 2007 (2020 Rev Ed)
Health Products Act 2007
Parent statute of Singapore health-product regulation, ingested as the 2020 Revised Edition served by Singapore Statutes Online (in operation since 31 December 2021, incorporating amendments to 5 December 2025 including the Statutes (Miscellaneous Amendments) Act 2025). All 75 sections across 14 Parts are in the corpus, with section 2 definitions split per term; the First Schedule carries the statutory definition of "medical device" (category 1). The 11 passage-specific fact URLs in the registry resolve onto stable section anchors in this document.
GeneralNovember 1, 2007Official
3D-Printed
Regulatory Guidelines for 3D-Printed Medical Devices
HSA guideline (July 2021, stating the current position as of 01 August 2022 in its conclusion) on additive-manufactured devices: categorisation of mass-produced versus custom-made and patient-matched devices with the in-line decision flowchart; regulatory controls by category (product registration including the Annex 2 for GN-17 list of configurations, the Table A basic dossier considerations for all 3D-printed devices, and dealer licensing with post-market obligations); plus IMDRF references. Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-4 with annex-references, the Table A considerations kept as tabular text with repeated table headers, and sub-sections 3.1–3.4 as anchored blocks.
Registration—Official
Aesthetic 2018
Regulatory Guidelines for Devices Intended for Modification of Appearance or Anatomy (Aesthetic-Related Guidelines)
HSA guideline (June 2018) on the risk-based approach to devices intended for modification of appearance or anatomy: the Annex A positive list of high-risk products, the in-line categorisation decision flowchart, and the Table 2 safety concerns and documentary requirements per product (implants, fillers, and other listed devices) feeding product registration and dealer controls. Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-4 with the multi-page Table 2 kept as tabular text including its repeated (continued) captions.
General—Official
Dealer License
Medical Device Dealer License
Dealer licensing requirements for importers, wholesalers, and manufacturers of medical devices in Singapore. License required before conducting business activities. The HSA site restructure removed the old /medical-devices/licensing path (now 404); the current licensing page lives under manufacturing-import-and-supply/dealers-licence and publishes no documents — the licensing GNs are linked from the guidance-documents collection.
Registration—Official
GL-04
Regulatory Guidelines for Software Medical Devices — A Life Cycle Approach
HSA GL-04 Revision 4 (December 2025), the life-cycle guidelines for software medical devices and Software as a Medical Device, covering change notification to registered software, cybersecurity, machine learning-enabled devices, and the Change Management Programme. Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-11 (References).
Software/SaMD—Official
GL-06
Medical Devices Product Classification Guide
HSA GL-06 Revision 2 (October 2023) on classifying borderline products: medical-related-purpose products against First Schedule versions, general purpose products, assistive technology, sports/fitness, and PPE. Exact PDF from the official guidance-documents collection. Ingested as six banner sections with the product-by-product classification tables kept as tabular text.
Classification—Official
GL-07
Guidelines on the Risk Classification of Software as a Medical Device and Clinical Decision Support Software
HSA GL-07 Revision 2 (July 2025) applying the IMDRF risk categorization framework to SaMD and setting out when clinical decision support software is regulated. Exact PDF from the official guidance-documents collection. Ingested as four banner sections (Introduction, Classification, Clinical Decision Support Software, References) with the risk-classification matrix kept as tabular text.
Software/SaMD—Official
GL-08
Regulatory Guidelines for Laboratory Developed Tests (LDTs)
HSA GL-08 Revision 2 (September 2025). Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-3 plus Annex 1.
General—Official
GL-10
Best Practices Guide for Medical Device Cybersecurity
HSA GL-10 Revision 1 (August 2026). Exact PDF resolved from the official go.gov.sg/gl-10-r1-14-08-2026 collection shortlink. Ingested as sec-1 through sec-9.
Software/SaMD—Official
GL-17
E-Submission Guide for General Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in SHARE
HSA GL-17 Revision 4 (October 2025). E-submission guide for general medical device product registration in SHARE, for submissions based on the ASEAN CSDT or the IMDRF ToC; section 2 covers the SHARE application form and responses to input-request queries, and section 3 is the Table 1 summary of submission requirements. Exact PDF from the official guidance-documents collection; ingested as the printed cover plus sec-1 through sec-3.
Registration—Official
GL-18
E-Submission Guide for In Vitro Diagnostic Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in SHARE
HSA GL-18 Revision 4 (October 2025). E-submission guide for IVD medical device product registration in SHARE, for submissions based on the ASEAN CSDT or the IVD ToC; section 2 covers the SHARE application form and responses to input-request queries, and section 3 is the Table 1 summary of submission requirements. Exact PDF from the official guidance-documents collection; ingested as the printed cover plus sec-1 through sec-3.
Registration—Official
GN-02
Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices
HSA GN-02 Revision 8 (April 2026). Exact PDF resolved from the official go.gov.sg/gn02r8 collection shortlink. Ingested as sec-1 through sec-9 plus Annexes 1, 2, and 5. Annexes 3 and 4 are separate templates, not this PDF.
GMP/QMS—Official
GN-03
Guidance on Preparation of a Site Master File for Licensing
HSA GN-03 Revision 3 (June 2011). Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-4 plus Annex 1.
GMP/QMS—Official
GN-04
Guidance on Medical Device Recall
HSA GN-04 Revision 2.2 (November 2017). Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-3 plus Annexes 1–2.
Vigilance—Official
GN-05
Guidance on the Reporting of Adverse Events
HSA GN-05 Revision 3 (8 September 2023). Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-9.
Vigilance—Official
GN-06
Guidance on Distribution Records for Medical Devices
HSA GN-06 Revision 3 (November 2022). Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-7.
GMP/QMS—Official
GN-07
Guidance on Complaint Handling
HSA GN-07 Revision 3 (September 2023). Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-4.
Vigilance—Official
GN-08
Guidance on Medical Device Advertisements and Sales Promotion
HSA GN-08 Revision 2 (June 2018). Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-7 plus Appendix A.
General—Official
GN-09
Guidance on the Component Elements of a Dear Healthcare Professional Letter
HSA GN-09 Revision 4 (July 2025). Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-2 plus Annex 1.
Vigilance—Official
GN-10
Guidance on Medical Device Field Safety Corrective Action
HSA GN-10 Revision 4 (July 2025). Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-14 plus Annex 1.
Vigilance—Official
GN-11
Guidance on the Declaration of Conformity
HSA GN-11 Revision 1.3 (November 2022). Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-3 plus Annex 1.
Registration—Official
GN-12-1
Guidance on Grouping of Medical Devices for Product Registration – General Grouping Criteria
HSA GN-12-1 Revision 3 (June 2026). Exact PDF resolved from the official go.gov.sg collection shortlink. Ingested as sec-1 through sec-3, including grouping categories sec-3-1 through sec-3-5.
Registration—Official
Exports carry source + retrieval date

Changes after registration in Singapore

Source-linked rules for common changes to a registered medical device. Read the scope and conditions with each rule; unverified details are listed separately.

Does changing a device brand name or logo require an update?

A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Registered name versus artwork changes

Fact-level verified

GN 21 covers registered MDs and IVDs. Product-name/identifier changes under 6C and product-owner name/address changes under 6D are Administrative CNs requiring approval before implementation. Listed colour, font, layout/design-only changes need no CN only under their stated safety/visibility conditions. Class A is outside this registered-device CN process, but its listing and dealer obligations remain. Assess each simultaneous change separately; an office address update is not automatically a manufacturing-site move.

GN-21 R7: Change Notification for Registered Medical Devices, August 2026 body

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Labels and identifiers

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Supporting documents

Use the exact 6C or 6D document column

Fact-level verified

For 6C name/identifier changes, the matrix calls for updated list of configurations, highlighted/final labels, DoC, LOA and the stated no-change declaration. For 6D full product-owner name changes it calls for labels, DoC, LOA and the owner undertaking on continued postmarket support where applicable. Address-only 6D instead marks labels and LOA; its column does not mark the DoC/undertaking. Other technical/site changes have their own matrix. These differences apply to the actual product-owner and change branch, not merely a commercial brand owner.

Health Products Act 2007, current 5 December 2025 expression

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Change-specific government fees

Notification-category CN has nil fee

Fact-level verified

The current fee table and Sixth Schedule specify nil fee for Notification-category CN. This does not cover Administrative 6C/6D or Technical/Review categories; those have their own fees. Multiple changes use the applicable highest category rather than an assumed per-field or nil fee.

Health Products (Fees) Regulations 2022, Sixth Schedule, current 1 July 2024 expressionGN-21 R7: Change Notification for Registered Medical Devices, August 2026 body

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Change-specific review time

CN review category and stop clock

Fact-level verified

HSA lists Administrative CN30 working days, Class B Review 45, Class C Technical 75 and Class D Technical 90 working days. These start at submission with applicant stop-clock time excluded. Notification-category implementation follows the acknowledgement email under its conditions; that is not a guaranteed zero-day Administrative approval. Select the highest applicable category for multiple changes and do not substitute new-registration clocks.

Annual retention, change of registrant and dealer-licence fees

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Labels and identifiers

Product-owner and registered identity on labels

Fact-level verified

Regulations 15/16 require the applicable product-owner name/trading name, address, telephone and email, device identity/brand and other particulars, with English legible information. GN 23 gives contact presentation examples including direct links; do not treat those examples as deleting the statutory fields. Update approved labels and applicable IFU versions for the actual 6C/6D change. Both MDs and IVDs fall within the Act definition.

GN-23 Guidance on Labelling for Medical Devices (Revision 2)Health Products Act 2007, current 5 December 2025 expression

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Labels and identifiers

Commercial REF is not automatically a new UDI

Fact-level verified

GN 36 says a new UDI-DI should be considered for changes such as brand, version/model and applicable packaging characteristics; use GN 21 to decide CN versus new registration. The UDI-only service changes specified DI/DM-DI/issuing-agency information for up to 30 listings and cannot change registered product information. The phased table has an earlier 1 November 2022 date for coronary stents, orthopaedic joint replacement implants and intraocular lenses, followed by all Class D devices on 1 November 2024, Class C on 1 November 2026 and Class B on 1 November 2028, with its tentative/future qualifications; Class A is voluntary. An order REF must be mapped to the actual registered identifiers before those rules are applied.

Conditions
  • The published GN 36 phased dates are subject to adjustment. Apply the actual HSA compliance date for the device category and import/supply date, including the earlier Phase 1 category where applicable.
MedicalDeviceUDI FAQ updated 18 July 2022; footerAugust 2021 retainedGN-21 R7: Change Notification for Registered Medical Devices, August 2026 body

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Existing stock and transition

Concurrent stock and owner-name phase-out are conditional

Fact-level verified

GN 21 permits old/new versions concurrently after CN approval only when both meet essential requirements and can be differentiated/traced through inventory and lots. For 6D product-owner changes, the submission proposes the old-contact-label phase-out timeline, HSA reviews/allows it, and consignees must be informed. Safety/FSCA directions override this arrangement. Approval is not an automatic unlimited old-owner stock grace.

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Existing stock and transition

The six-month UDI stock rule has an import-date condition

Fact-level verified

The UDI depletion period is six months only for stock imported before the applicable UDI compliance date. The FAQ says retain old/new UDI versions on the SMDR until old stock is depleted, then use CN to remove the old version. Neither statement grants every post-change brand/owner label six months of unrestricted sale.

MedicalDeviceUDI FAQ updated 18 July 2022; footerAugust 2021 retained

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Free sale certificate impact

CFS eligibility and issued-certificate changes

Fact-level verified

The current certificate service is available to the registered registrant or applicable Class A listing holder; Export Certificates concern local manufacturers of unregistered devices. Underlying company, licence, listing, site, device/model and product-number information must be accurate. Once issued, a certificate cannot be amended: a new application is needed for a replacement. Whether one is needed depends on the importing country and actual export. This is not a blanket CFS requirement for an ordinary CN.

HSA SHARE (Medical Device)Annual retention, change of registrant and dealer-licence feesHealth Products (Fees) Regulations 2022, Sixth Schedule, current 1 July 2024 expression

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Change-specific government fees

Conditions for this question

  • Only the applicable Class B CN: Administrative or Review as classified; not a nil Notification category.
  • Change-specific government fees

Conditions for this question

  • Only Class C Administrative CN, including eligible 6C/6D changes.
  • Change-specific government fees

Conditions for this question

  • Only an actual Class C Technical CN; do not classify an identifier-only 6C change as technical.
  • Change-specific government fees

Conditions for this question

  • Only Class D Administrative CN, including eligible 6C/6D changes.
  • Change-specific government fees

Conditions for this question

  • Only an actual Class D Technical CN; the ancillary medicinal-product branch has separate TAT conditions.
  • Change-specific government fees

Conditions for this question

  • Only a separate eligible certificate application; do not charge this automatically for CN.
  • This is the separate export-certificate facet, not the fee for the question main CN transaction.
  • Change-specific government fees

Conditions for this question

  • Only the actual certificate device/country processing scope. The service page and statutory wording differ on additional-country wording; no unsupported total is calculated.
  • This is the separate export-certificate facet, not the fee for the question main CN transaction.
Change control →Label, IFU & language →UDI, listing & traceability →

How do I update a manufacturer's name without changing the legal entity?

The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Registered name versus artwork changes

Fact-level verified

GN 21 covers registered MDs and IVDs. Product-name/identifier changes under 6C and product-owner name/address changes under 6D are Administrative CNs requiring approval before implementation. Listed colour, font, layout/design-only changes need no CN only under their stated safety/visibility conditions. Class A is outside this registered-device CN process, but its listing and dealer obligations remain. Assess each simultaneous change separately; an office address update is not automatically a manufacturing-site move.

GN-21 R7: Change Notification for Registered Medical Devices, August 2026 body

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Supporting documents

Use the exact 6C or 6D document column

Fact-level verified

For 6C name/identifier changes, the matrix calls for updated list of configurations, highlighted/final labels, DoC, LOA and the stated no-change declaration. For 6D full product-owner name changes it calls for labels, DoC, LOA and the owner undertaking on continued postmarket support where applicable. Address-only 6D instead marks labels and LOA; its column does not mark the DoC/undertaking. Other technical/site changes have their own matrix. These differences apply to the actual product-owner and change branch, not merely a commercial brand owner.

Health Products Act 2007, current 5 December 2025 expression

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Change-specific government fees

Notification-category CN has nil fee

Fact-level verified

The current fee table and Sixth Schedule specify nil fee for Notification-category CN. This does not cover Administrative 6C/6D or Technical/Review categories; those have their own fees. Multiple changes use the applicable highest category rather than an assumed per-field or nil fee.

Health Products (Fees) Regulations 2022, Sixth Schedule, current 1 July 2024 expressionGN-21 R7: Change Notification for Registered Medical Devices, August 2026 body

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Change-specific review time

CN review category and stop clock

Fact-level verified

HSA lists Administrative CN30 working days, Class B Review 45, Class C Technical 75 and Class D Technical 90 working days. These start at submission with applicant stop-clock time excluded. Notification-category implementation follows the acknowledgement email under its conditions; that is not a guaranteed zero-day Administrative approval. Select the highest applicable category for multiple changes and do not substitute new-registration clocks.

Annual retention, change of registrant and dealer-licence fees

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Labels and identifiers

Product-owner and registered identity on labels

Fact-level verified

Regulations 15/16 require the applicable product-owner name/trading name, address, telephone and email, device identity/brand and other particulars, with English legible information. GN 23 gives contact presentation examples including direct links; do not treat those examples as deleting the statutory fields. Update approved labels and applicable IFU versions for the actual 6C/6D change. Both MDs and IVDs fall within the Act definition.

GN-23 Guidance on Labelling for Medical Devices (Revision 2)Health Products Act 2007, current 5 December 2025 expression

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Labels and identifiers

Commercial REF is not automatically a new UDI

Fact-level verified

GN 36 says a new UDI-DI should be considered for changes such as brand, version/model and applicable packaging characteristics; use GN 21 to decide CN versus new registration. The UDI-only service changes specified DI/DM-DI/issuing-agency information for up to 30 listings and cannot change registered product information. The phased table has an earlier 1 November 2022 date for coronary stents, orthopaedic joint replacement implants and intraocular lenses, followed by all Class D devices on 1 November 2024, Class C on 1 November 2026 and Class B on 1 November 2028, with its tentative/future qualifications; Class A is voluntary. An order REF must be mapped to the actual registered identifiers before those rules are applied.

Conditions
  • The published GN 36 phased dates are subject to adjustment. Apply the actual HSA compliance date for the device category and import/supply date, including the earlier Phase 1 category where applicable.
MedicalDeviceUDI FAQ updated 18 July 2022; footerAugust 2021 retainedGN-21 R7: Change Notification for Registered Medical Devices, August 2026 body

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Labels and identifiers

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Existing stock and transition

Concurrent stock and owner-name phase-out are conditional

Fact-level verified

GN 21 permits old/new versions concurrently after CN approval only when both meet essential requirements and can be differentiated/traced through inventory and lots. For 6D product-owner changes, the submission proposes the old-contact-label phase-out timeline, HSA reviews/allows it, and consignees must be informed. Safety/FSCA directions override this arrangement. Approval is not an automatic unlimited old-owner stock grace.

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Existing stock and transition

The six-month UDI stock rule has an import-date condition

Fact-level verified

The UDI depletion period is six months only for stock imported before the applicable UDI compliance date. The FAQ says retain old/new UDI versions on the SMDR until old stock is depleted, then use CN to remove the old version. Neither statement grants every post-change brand/owner label six months of unrestricted sale.

MedicalDeviceUDI FAQ updated 18 July 2022; footerAugust 2021 retained

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Free sale certificate impact

CFS eligibility and issued-certificate changes

Fact-level verified

The current certificate service is available to the registered registrant or applicable Class A listing holder; Export Certificates concern local manufacturers of unregistered devices. Underlying company, licence, listing, site, device/model and product-number information must be accurate. Once issued, a certificate cannot be amended: a new application is needed for a replacement. Whether one is needed depends on the importing country and actual export. This is not a blanket CFS requirement for an ordinary CN.

HSA SHARE (Medical Device)Annual retention, change of registrant and dealer-licence feesHealth Products (Fees) Regulations 2022, Sixth Schedule, current 1 July 2024 expression

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Combined filing

CN grouping depends on dossiers, risk and actual change

Fact-level verified

Multiple changes within one dossier/single risk class may be included in a CN with the highest applicable category/fee/time. Across dossiers of the same class, the specified identical Administrative/Notification changes or limited device-identical technical changes may be grouped. Mixed-risk grouping is confined to 6D, 1A and 1E. An active listing may have at most two pending CNs; the third application is rejected in full without refund. These rules do not authorise every brand/REF/transfer combination in one application.

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Apply GN 21 section 4 to the actual dossier, risk class, identical change and product owner. Combining 6C with 6D across different risk classes is not established by the mixed-risk 6D/1A/1E-only allowance. A GN 24 local registrant transfer is a separate process.
  • Change-specific government fees

Conditions for this question

  • Only the applicable Class B CN: Administrative or Review as classified; not a nil Notification category.
  • Change-specific government fees

Conditions for this question

  • Only Class C Administrative CN, including eligible 6C/6D changes.
  • Change-specific government fees

Conditions for this question

  • Only an actual Class C Technical CN; do not classify an identifier-only 6C change as technical.
  • Change-specific government fees

Conditions for this question

  • Only Class D Administrative CN, including eligible 6C/6D changes.
  • Change-specific government fees

Conditions for this question

  • Only an actual Class D Technical CN; the ancillary medicinal-product branch has separate TAT conditions.
  • Change-specific government fees

Conditions for this question

  • Only a separate eligible certificate application; do not charge this automatically for CN.
  • This is the separate export-certificate facet, not the fee for the question main CN transaction.
  • Change-specific government fees

Conditions for this question

  • Only the actual certificate device/country processing scope. The service page and statutory wording differ on additional-country wording; no unsupported total is calculated.
  • This is the separate export-certificate facet, not the fee for the question main CN transaction.
Change control →Economic-operator roles →Label, IFU & language →

What changes when the manufacturer's office address changes?

An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Registered name versus artwork changes

Fact-level verified

GN 21 covers registered MDs and IVDs. Product-name/identifier changes under 6C and product-owner name/address changes under 6D are Administrative CNs requiring approval before implementation. Listed colour, font, layout/design-only changes need no CN only under their stated safety/visibility conditions. Class A is outside this registered-device CN process, but its listing and dealer obligations remain. Assess each simultaneous change separately; an office address update is not automatically a manufacturing-site move.

GN-21 R7: Change Notification for Registered Medical Devices, August 2026 body

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Supporting documents

Use the exact 6C or 6D document column

Fact-level verified

For 6C name/identifier changes, the matrix calls for updated list of configurations, highlighted/final labels, DoC, LOA and the stated no-change declaration. For 6D full product-owner name changes it calls for labels, DoC, LOA and the owner undertaking on continued postmarket support where applicable. Address-only 6D instead marks labels and LOA; its column does not mark the DoC/undertaking. Other technical/site changes have their own matrix. These differences apply to the actual product-owner and change branch, not merely a commercial brand owner.

Health Products Act 2007, current 5 December 2025 expression

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Change-specific government fees

Notification-category CN has nil fee

Fact-level verified

The current fee table and Sixth Schedule specify nil fee for Notification-category CN. This does not cover Administrative 6C/6D or Technical/Review categories; those have their own fees. Multiple changes use the applicable highest category rather than an assumed per-field or nil fee.

Health Products (Fees) Regulations 2022, Sixth Schedule, current 1 July 2024 expressionGN-21 R7: Change Notification for Registered Medical Devices, August 2026 body

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Change-specific review time

CN review category and stop clock

Fact-level verified

HSA lists Administrative CN30 working days, Class B Review 45, Class C Technical 75 and Class D Technical 90 working days. These start at submission with applicant stop-clock time excluded. Notification-category implementation follows the acknowledgement email under its conditions; that is not a guaranteed zero-day Administrative approval. Select the highest applicable category for multiple changes and do not substitute new-registration clocks.

Annual retention, change of registrant and dealer-licence fees

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Labels and identifiers

Product-owner and registered identity on labels

Fact-level verified

Regulations 15/16 require the applicable product-owner name/trading name, address, telephone and email, device identity/brand and other particulars, with English legible information. GN 23 gives contact presentation examples including direct links; do not treat those examples as deleting the statutory fields. Update approved labels and applicable IFU versions for the actual 6C/6D change. Both MDs and IVDs fall within the Act definition.

GN-23 Guidance on Labelling for Medical Devices (Revision 2)Health Products Act 2007, current 5 December 2025 expression

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Labels and identifiers

Commercial REF is not automatically a new UDI

Fact-level verified

GN 36 says a new UDI-DI should be considered for changes such as brand, version/model and applicable packaging characteristics; use GN 21 to decide CN versus new registration. The UDI-only service changes specified DI/DM-DI/issuing-agency information for up to 30 listings and cannot change registered product information. The phased table has an earlier 1 November 2022 date for coronary stents, orthopaedic joint replacement implants and intraocular lenses, followed by all Class D devices on 1 November 2024, Class C on 1 November 2026 and Class B on 1 November 2028, with its tentative/future qualifications; Class A is voluntary. An order REF must be mapped to the actual registered identifiers before those rules are applied.

Conditions
  • The published GN 36 phased dates are subject to adjustment. Apply the actual HSA compliance date for the device category and import/supply date, including the earlier Phase 1 category where applicable.
MedicalDeviceUDI FAQ updated 18 July 2022; footerAugust 2021 retainedGN-21 R7: Change Notification for Registered Medical Devices, August 2026 body

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Labels and identifiers

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Existing stock and transition

Concurrent stock and owner-name phase-out are conditional

Fact-level verified

GN 21 permits old/new versions concurrently after CN approval only when both meet essential requirements and can be differentiated/traced through inventory and lots. For 6D product-owner changes, the submission proposes the old-contact-label phase-out timeline, HSA reviews/allows it, and consignees must be informed. Safety/FSCA directions override this arrangement. Approval is not an automatic unlimited old-owner stock grace.

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Existing stock and transition

The six-month UDI stock rule has an import-date condition

Fact-level verified

The UDI depletion period is six months only for stock imported before the applicable UDI compliance date. The FAQ says retain old/new UDI versions on the SMDR until old stock is depleted, then use CN to remove the old version. Neither statement grants every post-change brand/owner label six months of unrestricted sale.

MedicalDeviceUDI FAQ updated 18 July 2022; footerAugust 2021 retained

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Free sale certificate impact

CFS eligibility and issued-certificate changes

Fact-level verified

The current certificate service is available to the registered registrant or applicable Class A listing holder; Export Certificates concern local manufacturers of unregistered devices. Underlying company, licence, listing, site, device/model and product-number information must be accurate. Once issued, a certificate cannot be amended: a new application is needed for a replacement. Whether one is needed depends on the importing country and actual export. This is not a blanket CFS requirement for an ordinary CN.

HSA SHARE (Medical Device)Annual retention, change of registrant and dealer-licence feesHealth Products (Fees) Regulations 2022, Sixth Schedule, current 1 July 2024 expression

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Combined filing

CN grouping depends on dossiers, risk and actual change

Fact-level verified

Multiple changes within one dossier/single risk class may be included in a CN with the highest applicable category/fee/time. Across dossiers of the same class, the specified identical Administrative/Notification changes or limited device-identical technical changes may be grouped. Mixed-risk grouping is confined to 6D, 1A and 1E. An active listing may have at most two pending CNs; the third application is rejected in full without refund. These rules do not authorise every brand/REF/transfer combination in one application.

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Apply GN 21 section 4 to the actual dossier, risk class, identical change and product owner. Combining 6C with 6D across different risk classes is not established by the mixed-risk 6D/1A/1E-only allowance. A GN 24 local registrant transfer is a separate process.
  • Change-specific government fees

Conditions for this question

  • Only the applicable Class B CN: Administrative or Review as classified; not a nil Notification category.
  • Change-specific government fees

Conditions for this question

  • Only Class C Administrative CN, including eligible 6C/6D changes.
  • Change-specific government fees

Conditions for this question

  • Only an actual Class C Technical CN; do not classify an identifier-only 6C change as technical.
  • Change-specific government fees

Conditions for this question

  • Only Class D Administrative CN, including eligible 6C/6D changes.
  • Change-specific government fees

Conditions for this question

  • Only an actual Class D Technical CN; the ancillary medicinal-product branch has separate TAT conditions.
  • Change-specific government fees

Conditions for this question

  • Only a separate eligible certificate application; do not charge this automatically for CN.
  • This is the separate export-certificate facet, not the fee for the question main CN transaction.
  • Change-specific government fees

Conditions for this question

  • Only the actual certificate device/country processing scope. The service page and statutory wording differ on additional-country wording; no unsupported total is calculated.
  • This is the separate export-certificate facet, not the fee for the question main CN transaction.
Change control →Economic-operator roles →Label, IFU & language →

Does a catalogue or reference code change affect registration or UDI?

Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Triggers for new registration instead of change notification

Fact-level verified

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 grouping criteria, and change of the registrable drug in a device.

Conditions
  • applies to registered devices

Confirms baseline triggers fact.

  • Filing route and prior approval

Registered name versus artwork changes

Fact-level verified

GN 21 covers registered MDs and IVDs. Product-name/identifier changes under 6C and product-owner name/address changes under 6D are Administrative CNs requiring approval before implementation. Listed colour, font, layout/design-only changes need no CN only under their stated safety/visibility conditions. Class A is outside this registered-device CN process, but its listing and dealer obligations remain. Assess each simultaneous change separately; an office address update is not automatically a manufacturing-site move.

GN-21 R7: Change Notification for Registered Medical Devices, August 2026 body

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Supporting documents

Use the exact 6C or 6D document column

Fact-level verified

For 6C name/identifier changes, the matrix calls for updated list of configurations, highlighted/final labels, DoC, LOA and the stated no-change declaration. For 6D full product-owner name changes it calls for labels, DoC, LOA and the owner undertaking on continued postmarket support where applicable. Address-only 6D instead marks labels and LOA; its column does not mark the DoC/undertaking. Other technical/site changes have their own matrix. These differences apply to the actual product-owner and change branch, not merely a commercial brand owner.

Health Products Act 2007, current 5 December 2025 expression

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Change-specific government fees

Notification-category CN has nil fee

Fact-level verified

The current fee table and Sixth Schedule specify nil fee for Notification-category CN. This does not cover Administrative 6C/6D or Technical/Review categories; those have their own fees. Multiple changes use the applicable highest category rather than an assumed per-field or nil fee.

Health Products (Fees) Regulations 2022, Sixth Schedule, current 1 July 2024 expressionGN-21 R7: Change Notification for Registered Medical Devices, August 2026 body

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Change-specific review time

CN review category and stop clock

Fact-level verified

HSA lists Administrative CN30 working days, Class B Review 45, Class C Technical 75 and Class D Technical 90 working days. These start at submission with applicant stop-clock time excluded. Notification-category implementation follows the acknowledgement email under its conditions; that is not a guaranteed zero-day Administrative approval. Select the highest applicable category for multiple changes and do not substitute new-registration clocks.

Annual retention, change of registrant and dealer-licence fees

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Labels and identifiers

Product-owner and registered identity on labels

Fact-level verified

Regulations 15/16 require the applicable product-owner name/trading name, address, telephone and email, device identity/brand and other particulars, with English legible information. GN 23 gives contact presentation examples including direct links; do not treat those examples as deleting the statutory fields. Update approved labels and applicable IFU versions for the actual 6C/6D change. Both MDs and IVDs fall within the Act definition.

GN-23 Guidance on Labelling for Medical Devices (Revision 2)Health Products Act 2007, current 5 December 2025 expression

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Labels and identifiers

Commercial REF is not automatically a new UDI

Fact-level verified

GN 36 says a new UDI-DI should be considered for changes such as brand, version/model and applicable packaging characteristics; use GN 21 to decide CN versus new registration. The UDI-only service changes specified DI/DM-DI/issuing-agency information for up to 30 listings and cannot change registered product information. The phased table has an earlier 1 November 2022 date for coronary stents, orthopaedic joint replacement implants and intraocular lenses, followed by all Class D devices on 1 November 2024, Class C on 1 November 2026 and Class B on 1 November 2028, with its tentative/future qualifications; Class A is voluntary. An order REF must be mapped to the actual registered identifiers before those rules are applied.

Conditions
  • The published GN 36 phased dates are subject to adjustment. Apply the actual HSA compliance date for the device category and import/supply date, including the earlier Phase 1 category where applicable.
MedicalDeviceUDI FAQ updated 18 July 2022; footerAugust 2021 retainedGN-21 R7: Change Notification for Registered Medical Devices, August 2026 body

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Labels and identifiers

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Existing stock and transition

Concurrent stock and owner-name phase-out are conditional

Fact-level verified

GN 21 permits old/new versions concurrently after CN approval only when both meet essential requirements and can be differentiated/traced through inventory and lots. For 6D product-owner changes, the submission proposes the old-contact-label phase-out timeline, HSA reviews/allows it, and consignees must be informed. Safety/FSCA directions override this arrangement. Approval is not an automatic unlimited old-owner stock grace.

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Existing stock and transition

The six-month UDI stock rule has an import-date condition

Fact-level verified

The UDI depletion period is six months only for stock imported before the applicable UDI compliance date. The FAQ says retain old/new UDI versions on the SMDR until old stock is depleted, then use CN to remove the old version. Neither statement grants every post-change brand/owner label six months of unrestricted sale.

MedicalDeviceUDI FAQ updated 18 July 2022; footerAugust 2021 retained

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Free sale certificate impact

CFS eligibility and issued-certificate changes

Fact-level verified

The current certificate service is available to the registered registrant or applicable Class A listing holder; Export Certificates concern local manufacturers of unregistered devices. Underlying company, licence, listing, site, device/model and product-number information must be accurate. Once issued, a certificate cannot be amended: a new application is needed for a replacement. Whether one is needed depends on the importing country and actual export. This is not a blanket CFS requirement for an ordinary CN.

HSA SHARE (Medical Device)Annual retention, change of registrant and dealer-licence feesHealth Products (Fees) Regulations 2022, Sixth Schedule, current 1 July 2024 expression

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Combined filing

CN grouping depends on dossiers, risk and actual change

Fact-level verified

Multiple changes within one dossier/single risk class may be included in a CN with the highest applicable category/fee/time. Across dossiers of the same class, the specified identical Administrative/Notification changes or limited device-identical technical changes may be grouped. Mixed-risk grouping is confined to 6D, 1A and 1E. An active listing may have at most two pending CNs; the third application is rejected in full without refund. These rules do not authorise every brand/REF/transfer combination in one application.

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Apply GN 21 section 4 to the actual dossier, risk class, identical change and product owner. Combining 6C with 6D across different risk classes is not established by the mixed-risk 6D/1A/1E-only allowance. A GN 24 local registrant transfer is a separate process.
  • Change-specific government fees

Conditions for this question

  • Only the applicable Class B CN: Administrative or Review as classified; not a nil Notification category.
  • Change-specific government fees

Conditions for this question

  • Only Class C Administrative CN, including eligible 6C/6D changes.
  • Change-specific government fees

Conditions for this question

  • Only an actual Class C Technical CN; do not classify an identifier-only 6C change as technical.
  • Change-specific government fees

Conditions for this question

  • Only Class D Administrative CN, including eligible 6C/6D changes.
  • Change-specific government fees

Conditions for this question

  • Only an actual Class D Technical CN; the ancillary medicinal-product branch has separate TAT conditions.
  • Change-specific government fees

Conditions for this question

  • Only a separate eligible certificate application; do not charge this automatically for CN.
  • This is the separate export-certificate facet, not the fee for the question main CN transaction.
  • Change-specific government fees

Conditions for this question

  • Only the actual certificate device/country processing scope. The service page and statutory wording differ on additional-country wording; no unsupported total is calculated.
  • This is the separate export-certificate facet, not the fee for the question main CN transaction.
Change control →UDI, listing & traceability →Label, IFU & language →

Can several changes be filed together?

Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Registered name versus artwork changes

Fact-level verified

GN 21 covers registered MDs and IVDs. Product-name/identifier changes under 6C and product-owner name/address changes under 6D are Administrative CNs requiring approval before implementation. Listed colour, font, layout/design-only changes need no CN only under their stated safety/visibility conditions. Class A is outside this registered-device CN process, but its listing and dealer obligations remain. Assess each simultaneous change separately; an office address update is not automatically a manufacturing-site move.

GN-21 R7: Change Notification for Registered Medical Devices, August 2026 body

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Combined filing
  • Filing route and prior approval
  • Supporting documents

Formal local registrant transfer is distinct from product ownership

Fact-level verified

GN 24 changes the local registrant for already-registered devices. The accepting company applies in SHARE, separately for each product owner, with no pending applications: complete or withdraw those first. The accepting company must ensure each SMDR listing remains valid for at least the next two months before its retention due date. Supply the product-owner letter of authorisation appointing the accepting registrant (GN 15 template), the separate product-owner request letter in Annex 1, and the relinquishing registrant declaration in Annex 2; the actual owner appointment precedes the request. Transfer takes effect on HSA approval. This does not itself change the foreign legal product owner, which must separately follow the applicable GN 21/new-registration assessment.

GN-21 R7: Change Notification for Registered Medical Devices, August 2026 bodyHSA SHARE (Medical Device)

Conditions for this question

  • Only if the local sponsor/registrant/company also changes; this does not substitute for a true foreign legal-manufacturer/product-owner transfer.
  • Only the expressly cited sequence or pending-application constraint is supported for the actual local role/process. This does not establish one combined application, total fee or shared approval date for a REF/brand/name/office/manufacturer-transfer tuple.
  • Filing route and prior approval

Same-UEN company synchronisation versus a new legal entity

Fact-level verified

For the same UEN, update the company name/business address in ACRA; SHARE synchronises on next login. HSA states that licences and certificates cannot transfer between UENs; the new UEN must obtain the required new licences/certificates. Product-registration change-of-registrant remains a distinct GN 24 process. This local company synchronisation is not a procedure for renaming a foreign manufacturer/product owner.

GN-24 R2: Change of Registrant, July 2025

Conditions for this question

  • Only if the local sponsor/registrant/company also changes; this does not substitute for a true foreign legal-manufacturer/product-owner transfer.
  • Filing route and prior approval

Triggers for new registration instead of change notification

Fact-level verified

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 grouping criteria, and change of the registrable drug in a device.

Conditions
  • applies to registered devices

Confirms baseline triggers fact.

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Supporting documents

Use the exact 6C or 6D document column

Fact-level verified

For 6C name/identifier changes, the matrix calls for updated list of configurations, highlighted/final labels, DoC, LOA and the stated no-change declaration. For 6D full product-owner name changes it calls for labels, DoC, LOA and the owner undertaking on continued postmarket support where applicable. Address-only 6D instead marks labels and LOA; its column does not mark the DoC/undertaking. Other technical/site changes have their own matrix. These differences apply to the actual product-owner and change branch, not merely a commercial brand owner.

Health Products Act 2007, current 5 December 2025 expression

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Change-specific government fees

Notification-category CN has nil fee

Fact-level verified

The current fee table and Sixth Schedule specify nil fee for Notification-category CN. This does not cover Administrative 6C/6D or Technical/Review categories; those have their own fees. Multiple changes use the applicable highest category rather than an assumed per-field or nil fee.

Health Products (Fees) Regulations 2022, Sixth Schedule, current 1 July 2024 expressionGN-21 R7: Change Notification for Registered Medical Devices, August 2026 body

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Change-specific review time

CN review category and stop clock

Fact-level verified

HSA lists Administrative CN30 working days, Class B Review 45, Class C Technical 75 and Class D Technical 90 working days. These start at submission with applicant stop-clock time excluded. Notification-category implementation follows the acknowledgement email under its conditions; that is not a guaranteed zero-day Administrative approval. Select the highest applicable category for multiple changes and do not substitute new-registration clocks.

Annual retention, change of registrant and dealer-licence fees

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Change-specific review time

Formal change-of-registrant review target

Fact-level verified

The current HSA table specifies 40 working days for a formal change of registrant, subject to the stated service conditions. This is distinct from Administrative CN30 working days and from the underlying owner appointment or applicant response time. No pending-applications prerequisite means simultaneous pending transfer and CN cannot simply be assumed.

GN-24 R2: Change of Registrant, July 2025

Conditions for this question

  • Only if the local sponsor/registrant/company also changes; this does not substitute for a true foreign legal-manufacturer/product-owner transfer.
  • Labels and identifiers

Product-owner and registered identity on labels

Fact-level verified

Regulations 15/16 require the applicable product-owner name/trading name, address, telephone and email, device identity/brand and other particulars, with English legible information. GN 23 gives contact presentation examples including direct links; do not treat those examples as deleting the statutory fields. Update approved labels and applicable IFU versions for the actual 6C/6D change. Both MDs and IVDs fall within the Act definition.

GN-23 Guidance on Labelling for Medical Devices (Revision 2)Health Products Act 2007, current 5 December 2025 expression

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Labels and identifiers

Commercial REF is not automatically a new UDI

Fact-level verified

GN 36 says a new UDI-DI should be considered for changes such as brand, version/model and applicable packaging characteristics; use GN 21 to decide CN versus new registration. The UDI-only service changes specified DI/DM-DI/issuing-agency information for up to 30 listings and cannot change registered product information. The phased table has an earlier 1 November 2022 date for coronary stents, orthopaedic joint replacement implants and intraocular lenses, followed by all Class D devices on 1 November 2024, Class C on 1 November 2026 and Class B on 1 November 2028, with its tentative/future qualifications; Class A is voluntary. An order REF must be mapped to the actual registered identifiers before those rules are applied.

Conditions
  • The published GN 36 phased dates are subject to adjustment. Apply the actual HSA compliance date for the device category and import/supply date, including the earlier Phase 1 category where applicable.
MedicalDeviceUDI FAQ updated 18 July 2022; footerAugust 2021 retainedGN-21 R7: Change Notification for Registered Medical Devices, August 2026 body

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Labels and identifiers

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Existing stock and transition

Concurrent stock and owner-name phase-out are conditional

Fact-level verified

GN 21 permits old/new versions concurrently after CN approval only when both meet essential requirements and can be differentiated/traced through inventory and lots. For 6D product-owner changes, the submission proposes the old-contact-label phase-out timeline, HSA reviews/allows it, and consignees must be informed. Safety/FSCA directions override this arrangement. Approval is not an automatic unlimited old-owner stock grace.

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Existing stock and transition

The six-month UDI stock rule has an import-date condition

Fact-level verified

The UDI depletion period is six months only for stock imported before the applicable UDI compliance date. The FAQ says retain old/new UDI versions on the SMDR until old stock is depleted, then use CN to remove the old version. Neither statement grants every post-change brand/owner label six months of unrestricted sale.

MedicalDeviceUDI FAQ updated 18 July 2022; footerAugust 2021 retained

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Free sale certificate impact

CFS eligibility and issued-certificate changes

Fact-level verified

The current certificate service is available to the registered registrant or applicable Class A listing holder; Export Certificates concern local manufacturers of unregistered devices. Underlying company, licence, listing, site, device/model and product-number information must be accurate. Once issued, a certificate cannot be amended: a new application is needed for a replacement. Whether one is needed depends on the importing country and actual export. This is not a blanket CFS requirement for an ordinary CN.

HSA SHARE (Medical Device)Annual retention, change of registrant and dealer-licence feesHealth Products (Fees) Regulations 2022, Sixth Schedule, current 1 July 2024 expression

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Combined filing

CN grouping depends on dossiers, risk and actual change

Fact-level verified

Multiple changes within one dossier/single risk class may be included in a CN with the highest applicable category/fee/time. Across dossiers of the same class, the specified identical Administrative/Notification changes or limited device-identical technical changes may be grouped. Mixed-risk grouping is confined to 6D, 1A and 1E. An active listing may have at most two pending CNs; the third application is rejected in full without refund. These rules do not authorise every brand/REF/transfer combination in one application.

Conditions for this question

  • Apply only the actual change and legal actor described in this fact; the question does not make every potential filing compulsory.
  • Apply GN 21 section 4 to the actual dossier, risk class, identical change and product owner. Combining 6C with 6D across different risk classes is not established by the mixed-risk 6D/1A/1E-only allowance. A GN 24 local registrant transfer is a separate process.
  • Change-specific government fees

Conditions for this question

  • Only the applicable Class B CN: Administrative or Review as classified; not a nil Notification category.
  • Change-specific government fees

Conditions for this question

  • Only Class C Administrative CN, including eligible 6C/6D changes.
  • Change-specific government fees

Conditions for this question

  • Only an actual Class C Technical CN; do not classify an identifier-only 6C change as technical.
  • Change-specific government fees

Conditions for this question

  • Only Class D Administrative CN, including eligible 6C/6D changes.
  • Change-specific government fees

Conditions for this question

  • Only an actual Class D Technical CN; the ancillary medicinal-product branch has separate TAT conditions.
  • Change-specific government fees

Conditions for this question

  • Only the separate formal local change-of-registrant application, not foreign-owner 6D or same-UEN synchronisation.
  • Change-specific government fees

Conditions for this question

  • Only a separate eligible certificate application; do not charge this automatically for CN.
  • This is the separate export-certificate facet, not the fee for the question main CN transaction.
  • Change-specific government fees

Conditions for this question

  • Only the actual certificate device/country processing scope. The service page and statutory wording differ on additional-country wording; no unsupported total is calculated.
  • This is the separate export-certificate facet, not the fee for the question main CN transaction.
Change control →Official forms & portals →Dossier requirements →
Regulation codes

What these codes are

Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.

Use this market context

Continue from regulations into practical research

Keep Singapore as the target market while you move into registration records, classification, cross-country product research, or pathway planning.

Classify a device for Singapore

Check a preliminary HSA risk class.

Search registered products

Inspect public HSA records.

Compare products across markets

Search the same product in multiple country registries.

Build a registration plan

Estimate pathway, government fees, preparation, and review time.

Build a reusable product master

Structure company, product, model, approval, and evidence facts once.

Map dossier reuse and deltas

Compare existing evidence against Singapore needs.

Build a market-launch workpaper

Connect route, evidence, labels, representatives, and launch dependencies.

Assess a regulatory change

Test a current HSA update against one product and its evidence.

Keep researching this market

More Singapore medical device resources

View the Singapore resource hub →
Compare regulations across all countries →
Continue with this market
Tracked from official HSA publications · row IDs are stable — cite as regulations:singapore:sg-3d-printed-devices