HSA GN-21 R7 Change Notification: 6Aii/6Aiii Approval, Two-CN Cap, & August Clock

For regulatory affairs directors, qualified Singapore registrants, authorized dealers, and international manufacturers managing Class B, Class C, and Class D medical devices listed on the Singapore Medical Device Register (SMDR), post-market change management hit a procedural inflection point on 1 August 2026.

In August 2026, the Singapore Health Sciences Authority (HSA) issued a 60-page revision of GN-21: Guidance on Change Notification for Registered Medical Devices, Revision 7 (shortlink: go.gov.sg/gn-21-r7-31-07-2026), accompanied by Annex 2 to GN-21: Summary Table of Change Notification (August 2026 Word file). The guidance tells registrants how to notify changes under the Health Products (Medical Devices) Regulations 2010. It is not itself a statute.

Search results have not caught up:

1. HSA's HTML how-to (Notify changes to registered medical devices, last updated 13 March 2026) still tells readers they may implement Administrative changes that fall under 6Aii/6Aiii of Flowchart 6A immediately upon the acknowledgement email.
2. HSA's 4 July 2025 announcement (Updates to GN-21) still ranks. It describes Revision 6, effective 14 July 2025, including Flowchart 2.5 for Machine Learning-enabled Medical Devices (MLMD) and change type 6E. It is not the August 2026 operating text.
3. The PDF itself uses two labels for the same file: the cover says Revision 7 (August 2026); the revision-history table on page 4 records GN-21: Revision 6.1 (01 Aug 2026).
4. Consultant restatements of Revision 6 still omit the Revision 7 Administrative paragraph that requires approval before implementing 6Aii/6Aiii public listing updates, and they omit Annex 2's two-active-CN cap.

Direct Answer. HSA's current change-notification guidance is GN-21 Revision 7, cover dated August 2026 (60 pages). The revision-history table labels that same file GN-21: Revision 6.1 (01 Aug 2026). HSA's guidance list (last updated 26 August 2026) publishes GN-21-R7 (2026 Jul) plus Annex 2 (2026 Aug) and marks GN-21-R6 archived on 31 July 2026. Until HSA refreshes the March 2026 HTML how-to, use the Revision 7 PDF and the August 2026 Annex 2 .docx as the operating text. Do not treat the HTML page or the 4 July 2025 announcement as the current implementation rule.

Under the Revision 7 Administrative paragraph (page 11), changes to administrative documents and information submitted at registration, and all other changes to device particulars published on the public SMDR listing that fall under 6Aii/6Aiii of Flowchart 6A, require HSA's approval prior to implementation in Singapore. Flowchart 6A classifies 6Aii as same-design additions (models within the existing registered size range, pack-count changes without breaching individual primary packaging, volume changes that do not affect specifications, or repackaged combinations of existing models) and 6Aiii as adding a new device or software identifier with no change to performance characteristics or specifications. Both are Administrative for Class B, C, and D.

Notification changes may still be implemented immediately upon the SHARE (Singapore Health Product Access and Regulatory E-System) acknowledgement email: deletions or removals of published listing particulars, and other changes that are not Administrative, Technical, or Review, unless section 2.3 says no Change Notification is required. Incorrectly classified Notification applications are rejected on review, and further supply of the affected device is prohibited until the change is approved in the correct category. Class A devices: do not submit a GN-21 Change Notification; list them on the Class A Medical Device Database per GN-22.

Annex 2 (August 2026): at submission there can be no more than two active CN applications for the same listing. If any listing in the application already has two active CNs, the entire application is rejected and fees paid are not refunded.

Table 2 TAT is in working days from submission, excludes applicant stop-clock, and follows the highest category in the filing: Class B Review 45 / Administrative 30; Class C Administrative 30 / Technical 75; Class D Administrative 30 / Technical 90. Official fees (HSA schedule, last updated 26 March 2026, SGD): Notification none; Administrative $560; Class B Review $560; Class C Technical $1,890; Class D Technical $3,120. All submitted SHARE fees are non-refundable.

Do not count 20,860 public SMDR listing records in a 3 September 2026 extract of the data.gov.sg registered-device dataset, or the 12,629 rows with a populated change-notification approval date, as an active SHARE job queue or a 6Aii census. That extract is a listing inventory.

Dimension	GN-21 Revision 7	What to do
Guidance status	Cover: Revision 7 (August 2026); history: Revision 6.1 (01 Aug 2026); R6 archived 31 July 2026	Follow the R7 PDF and August 2026 Annex 2. The March 2026 HTML Implementation bullets are stale.
6Aii / 6Aiii SMDR additions	Administrative; HSA approval before implementation in Singapore	Do not import or sell the new size, pack, identifier, or software ID on SHARE acknowledgement.
Notification	Deletions of published particulars, plus residual non-Admin/Review/Technical changes (unless section 2.3 exempts them)	May implement on the SHARE acknowledgement email; file within 6 months of first global implementation.
Misclassified Notification	Rejected on review; further supply of the affected device prohibited	Re-file in the correct category and wait for approval before supplying.
Two-active-CN cap (Annex 2)	No more than two active CNs per listing at submission; third filing rejected in entirety	Audit SHARE jobs per listing before filing. Rejection forfeits submitted fees.
Table 2 TAT	Working days, stop-clock excluded, highest category: Admin 30; Class B Review 45; Class C Tech 75; Class D Tech 90	Do not treat 1 August 2026 as application expiry. Contact HSA for TAT on medicinal-product changes in Class D combination devices.
Statutory fees (SGD, 26 March 2026)	Notification $0; Admin $560; Class B Review $560; Class C Tech $1,890; Class D Tech $3,120	Fees are official HSA amounts, per application, non-refundable once submitted via SHARE.
Class A	Out of GN-21; Class A Medical Device Database / GN-22	Do not file a GN-21 CN for Class A devices.
Public SMDR extract	20,860 listing rows as of 3 September 2026; 12,629 with a CN approval date	Listing inventory only. Not a SHARE backlog.

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Is GN-21 Revision 7 Already the Operating File, or Do We Still Follow Revision 6 and the March 2026 HTML Page?

The friction is the split between HSA's PDF, its archived announcement, and its public website.

HSA's HTML page Notify changes to registered medical devices (last updated 13 March 2026) still says, in the Implementation section, that Notification changes and Administrative changes that fall under 6Aii/6Aiii of Flowchart 6A may be implemented immediately upon the acknowledgement email. Search also still surfaces the 4 July 2025 announcement, which launched Revision 6 (effective 14 July 2025).

Layer	Instrument	Date	Operational status
Statute / regulations	Health Products Act 2007; Health Products (Medical Devices) Regulations 2010	In force (as amended)	Binding. Registrants must notify changes concerning registered medical devices.
Operational guidance	GN-21 Revision 7 (cover August 2026; history Revision 6.1, 01 Aug 2026)	Effective 1 August 2026	Current. Sets the 6Aii/6Aiii prior-approval rule.
Procedural annex	Annex 2 to GN-21 (Word .docx)	August 2026	Current. Two-active-CN cap and the summary table.
Superseded guidance	GN-21 Revision 6	Effective 14 July 2025; archived 31 July 2026	Not the file for new SHARE Change Notifications.
Contrast announcement	Updates to GN-21	4 July 2025	Revision 6 launch only.
Contrast web how-to	Notify changes to registered medical devices	Last updated 13 March 2026	Informational page whose Implementation bullets still list 6Aii/6Aiii as implement-on-acknowledgement.

Revision 7 versus Revision 6.1

The 31 July 2026 PDF uses two labels for one document:

• Cover: GN-21: Guidance on Change Notification for Registered Medical Devices, Revision 7, August 2026.
• Revision history (page 4): R7 ► GN-21: Revision 6.1 (01 Aug 2026). The table does not add a separate prose summary of the R7 edits; those edits are marked with R7 ► in the body, including the Administrative paragraph on page 11.
• Guidance list (last updated 26 August 2026): GN-21-R7 (2026 Jul) plus Annex 2 (2026 Aug); GN-21-R6 (2025 Jul) archived on 31 July 2026.

Treat them as the same authentic file, not as two laws. In SHARE correspondence, follow the guidance-list label GN-21-R7.

The HTML page is not a defence for commercializing unapproved line extensions. GN-21 is guidance on how HSA expects Change Notifications to be classified and implemented. The Regulations still require notification of changes. If the how-to and the PDF disagree, use the PDF and Annex 2 until HSA updates the HTML Implementation section.

For how devices get onto the SMDR in the first place, see the Singapore HSA medical device registration guide and the ASEAN country-by-country registration overview. Those pages own registration routes, not this Revision 7 implementation gate.

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When Must 6Aii/6Aiii Public SMDR Listing Changes Wait for HSA Approval, and When May Notification Changes Still Go Live on SHARE Acknowledgement?

The material Revision 7 change is the gating of public SMDR listing additions that sit in Flowchart 6A as 6Aii or 6Aiii.

Under Revision 6, those Administrative additions could be implemented when SHARE sent the acknowledgement email, while HSA verified the paperwork. Revision 7 ends that practice for 6Aii/6Aiii public listing modifications.

The Revision 7 Administrative paragraph

On page 11, under Categories of Changes, HSA states:

Changes to the administrative documents and information submitted at the point of registration of the medical device as well as all other changes to device particulars which are published on public SMDR listing that fall under 6Aii/6Aiii of the Flowchart 6A. These require HSA's approval prior to implementation of the change(s) in Singapore.

Proposed change	GN-21 category (Class B / C / D)	Implement in Singapore
6Ai: addition beyond the existing registered size range, or addition that affects design, specifications, or performance	Review (Class B) or Technical (Class C/D)	After HSA approval
6Aii: same-design addition within the registered size range; pack-count change without breaching individual primary packaging; volume change that does not affect specifications; repackaging of existing models in the same listing	Administrative (all classes)	After HSA approval (not on SHARE acknowledgement)
6Aiii: new device or software identifier with no change to performance characteristics or specifications	Administrative (all classes)	After HSA approval (not on SHARE acknowledgement)
6B: deletion of models from the listing	Notification (all classes)	On SHARE acknowledgement email
6C: product name and/or product identifier of the registered device	Administrative (all classes)	After HSA approval
6D: product-owner name/address	Administrative (all classes)	After HSA approval
6E: submit UDI data elements for registered devices	Notification (all classes)	On SHARE acknowledgement email
Residual change that is not Admin/Review/Technical, and is not listed in section 2.3	Notification	On SHARE acknowledgement email
Section 2.3 examples (layout/font/colour with no change in warning prominence; adding UDI on the label without changing listing information; certification-body change with no QMS-scope change; and the other listed exemptions)	No Change Notification	Follow section 2.3; do not file a Notification just to "be safe" if the change is exempt

Flowchart 6A boundaries

Flowchart 6A (page 30) and the Annex 3 change-type list are the classification tools. The PDF's own examples matter more than catalogue folklore.

6Ai (Review or Technical). Adding models that sit beyond the existing range of registered sizes, and/or that affect device design, specifications, and/or performance. The PDF example is adding two new stent lengths that are not within the already-registered size range of a stent family.

6Aii (Administrative — approval required). Adding a new device of the same design that only involves:

• new models within the existing range of sizes already registered; and/or
• increase or reduction in the number of identical devices in a pack of a registered device without breach of individual primary packaging; and/or
• increase or reduction of volume that does not affect specifications (the PDF lists shelf life, stability, performance, sterility as examples); and/or
• new models from repackaging existing models within the same SMDR listing in different combinations, again without breaching individual primary packaging.

6Aiii (Administrative — approval required). Adding a new device or software identifier with no change to performance characteristics or specifications. The PDF examples are:

• changes that improve device ergonomics or aesthetic modification of the device (when that addition is filed as a new identifier on the listing);
• software changes solely to correct an inadvertent software error that does not add new functions, does not pose a safety risk, and is intended to bring the system to specification.

Do not dump every identifier problem into 6Aiii. Product name and/or product identifier of an already-registered device is 6C (Administrative). Submitting UDI data elements for registered devices is 6E (Notification). Adding a UDI on the physical label without changing listing information can be a section 2.3 no-CN labelling change. Those are different SHARE jobs from 6Aiii.

What remains implementable on SHARE acknowledgement

Notification is preserved. Registrants may implement immediately upon the SHARE acknowledgement email for:

1. 6B deletions of published models from the listing.
2. Other changes that are not Administrative, Technical, or Review, unless section 2.3 says no CN is required.
3. 6E UDI data-element submissions (Notification for all risk classes).

Typical Notification examples elsewhere in the flowcharts include an update of QMS certificate validity date with no site or scope change. That is not a licence to re-label a 6Aii pack-count change as Notification.

Section 2.3 still carves out changes that do not require a CN at all, including several labelling layout/font/barcode/UDI-on-label items, a certification-body change with no QMS-scope change, and a design change that does not affect performance or specifications (the PDF's ergonomics/aesthetic example). Filing those as Notification is unnecessary; filing a 6Aii addition as if it were a section 2.3 aesthetic tweak is the opposite error.

If the change is in the context of a reportable AE or an ongoing FSCA, GN-21 says implementation can proceed only after those cases have been reported to the Medical Devices Cluster, and AE/FSCA-related changes require prior HSA approval regardless of the selected category unless HSA has given written advice otherwise.

The misclassification supply stop

The NOTE on page 12 is not tucked inside section 2.1 (Class A). It sits under Categories of Changes:

'Notification' changes which are incorrectly classified will be rejected upon review and further supply of the affected device will be prohibited. Subsequent supply will be subject to approval of the change in the correct Change Notification category.

If a registrant files three new catheter diameters that belong in 6Aii as a Notification in order to ship a hospital tender on acknowledgement, HSA can reject the file. Further supply of the affected device is then prohibited until the correct category is approved. GN-21 is the operating rule. Separately, section 15 of the Health Products Act prohibits supply of unregistered health products except as prescribed. New models that are not yet on the SMDR listing are the practical risk. For classification questions, GN-21 points registrants to the Medical Devices Cluster.

Notification bundling is also on page 11, not in section 2.2 (AE/FSCA). Eligible Notification changes may be bundled in one CN, or submitted with the next Review/Technical change, whichever comes first. Any such change must still be submitted within a maximum of 6 months from the point of first implementation, globally. Companies must keep inventory records for traceability. Bundled Notification does not apply to MLMD that incorporates generative AI and continuous learning, to changes to the drug substance/medicinal product of combination products, or to AE/FSCA-related changes.

For how this Singapore gate sits next to FDA/EU/Asia change tiers, see the medical device post-approval change management guide.

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What Does the Annex 2 Two-Active-CN Cap Reject, and Is the Fee Refunded?

The companion Annex 2 (August 2026) is an official Word file on file.go.gov.sg, not a PDF. The R7 note in that annex states:

At the point of submission, there can be no more than two (2) CN applications that are active for the same listing. A CN application will be rejected in its entirety if any listing within it already has two (2) active CN applications. There will be no refund of any fees paid.

SHARE situation at submission	Result
Listing A has 0 or 1 active CN	A further CN on that listing may be submitted (until it would become a third active file)
Listing B already has 2 active CNs	A new CN that includes listing B is rejected in its entirety
One dossier covers listings A, B, C, and D, and only B already has 2 active CNs	The whole application is rejected. A, C, and D are not split out and reviewed

What the cap actually does

Listing-level test, dossier-level rejection. The limit is per SMDR listing. Bundling several listings into one CN does not create a spare slot. If one listing in the bundle is already at two active CNs, Annex 2 rejects the application as a whole.

No fee refund. Section 6 of GN-21: all fees are non-refundable once the application has been submitted via SHARE. Withdrawal or rejection forfeits the fees charged. The HSA fees page says the same. If a Class D Technical CN (SGD 3,120 on the 26 March 2026 schedule) is rejected under the two-CN cap, that official fee is not credited, rolled over, or transferred.

Shared listing, shared cap. The registrant files Change Notifications in SHARE. If more than one person can originate jobs against the same listing — for example a corporate RA team and a local registrant using the same SHARE company account — they still share the two-active-CN ceiling. Do not assume a second dealer can open a third job because they hold a separate importer's licence.

Practical queue controls

• Before upload, inspect every target listing's active CN status in SHARE. If two jobs are already open, wait for an approval or close-out on at least one.
• Do not bundle a high-churn consumable listing with a static capital-equipment listing if the consumable listing is already near the cap.
• If you need both a 6Aii Administrative addition (30 working-day TAT) and a Class C Technical change (75 working days), decide whether to file them separately in sequence or together under the Technical TAT and Technical fee. Section 4 of GN-21 charges fees and TAT on a per-application, highest-category basis.

This is a Singapore SHARE rule. It is not Malaysia's MeDC@St "pending CN hides the re-registration button" gate; that instrument is covered in the Malaysia MDA automated re-registration guide.

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Which Clock Applies: Table 2 Working-Day TAT, Notification Acknowledgement, or a New Application Expiry?

Do not collapse four clocks into one.

Clock	What it is	What it is not
1 August 2026	Effective date of GN-21 Revision 6.1 / Revision 7	Not SMDR expiry. Not a new product-registration deadline.
Notification acknowledgement	Implement eligible Notification changes when the SHARE acknowledgement email arrives	Not approval of 6Aii/6Aiii, 6C, 6D, Review, or Technical changes
Table 2 TAT	HSA working-day target from submission, excluding applicant stop-clock; highest category in the application	Not calendar days. Not a guarantee.
Six-month Notification window	File eligible Notification changes within 6 months of first global implementation	Not a 6-month licence to skip the category test

Table 2 (page 36):

Change category	Risk class	Table 2 TAT (working days)	Official fee (SGD, 26 March 2026)	Implementation
Notification	Class B, C, D	Immediate acknowledgement (not a Table 2 evaluation TAT)	$0	On SHARE acknowledgement
Administrative (including 6Aii/6Aiii, 6C, 6D)	Class B, C, D	30	$560	After HSA approval
Review (closed list)	Class B	45	$560	After HSA approval
Technical	Class C	75	$1,890	After HSA approval
Technical	Class D	90	$3,120	After HSA approval
Administrative	Class D with registrable drug	Contact HSA (fees page)	$560	After HSA approval
Changes to the medicinal product in a Class D device with a registrable medicinal product in an ancillary role	Class D combination	Contact HSA (Table 2 footnote)	Contact HSA; do not invent a Technical tariff	After HSA approval

Working days exclude Saturdays, Sundays, and Singapore public holidays. Stop-clock is the time HSA spends waiting for the applicant to answer an input request. A file can be non-approvable if the applicant misses the time stated in that input request. Use the deadline on the SHARE query; GN-21 does not publish one universal response period.

Highest-category bundling is explicit: a Class C Technical change plus an Administrative 6Aii addition in one application takes the Class C Technical TAT and the Class C Technical fee.

The Table 2 footnote is narrower than a blanket "all Class D combination-product Technical TATs are unpublished." It applies to changes to the medicinal product in Class D devices that incorporate a registrable medicinal product in an ancillary role. The fees page, separately, tells applicants to contact HSA for TAT on Administrative CNs for Class D with registrable drug. Those 195 public SMDR rows labelled "D WITH MEDICINAL PRODUCT" in the 3 September 2026 extract are a listing mix, not a CN-type mix and not a published TAT table.

1 August 2026 is an effective date

SMDR listings do not expire on 1 August 2026. They remain on the register subject to the annual retention fees on the HSA fees page (Class B SGD 39, Class C SGD 67, Class D SGD 134, Class D with registrable drug SGD 134). GN-21 Revision 7 does not publish a grandfathering clause for Change Notifications already sitting in SHARE before 1 August 2026. For those in-flight files, ask the Medical Devices Cluster rather than assuming Revision 6 still governs them.

After approval, section 4.2 allows concurrent supply of the original and changed device if both conform to the Essential Requirements, with traceability records. Concurrent supply of AE/FSCA-driven changes follows HSA's written advice in that case file, not the default 4.2 paragraph.

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What Fails If You Treat the July 2025 Announcement, the R6 PDF, or 20,860 SMDR Rows as the Legal Text?

Failure mode	Cause	What actually happens	Prevention
Shipping 6Aii/6Aiii SKUs on SHARE acknowledgement	Following the 13 March 2026 HTML Implementation bullets	GN-21 requires prior approval; further supply can be prohibited if the file was also misclassified as Notification	Freeze Singapore supply of the new identifier until HSA approves the CN and the SMDR listing shows it
Third active CN on one listing	Ignoring Annex 2	Entire application rejected; submitted fees forfeited	Census active SHARE jobs per listing before upload
Bundling a capped listing with clean listings	One composite dossier	Clean listings are rejected too	File the capped listing separately after a slot opens
GN-21 CN for a Class A device	Treating the Class A database like SMDR	GN-21 section 2.1: do not submit	Use GN-22 and the Class A Medical Device Database
Using GN-15 evaluation-route memos as the CN category	Mixing pre-market routes with post-listing changes	Wrong dossier shape and stop-clock	Classify with GN-21 flowcharts; pull CSDT evidence from Annex 1
Counting 20,860 SMDR rows as open SHARE jobs	Reading a public listing extract as a queue	Bad capacity and backlog stories	Use SHARE, not data.gov.sg, for active CN status

Premature commercialization

A supply-chain lead reads the March 2026 HTML page, sees 6Aii/6Aiii under "implement upon acknowledgement," and releases new catheter lengths. Under Revision 7 those lengths need approval first. If the CN was also filed as Notification, page 12 prohibits further supply of the affected device until the correct category is approved.

Multi-listing cap forfeiture

Ten analyzers go into one Administrative 6Aiii identifier CN at SGD 560. Analyzer 4 already has two active CNs. Annex 2 rejects the application for all ten. The SGD 560 is not refunded.

Class A filing

Section 2.1: do not submit Change Notification for Class A devices (including adding Class A devices to registered listings or changing identifiers of Class A listed devices). Class A devices are listed in the Class A Medical Device Database. Dealer licensing and post-market duties still apply. The companion document is GN-22: Guidance for Dealers on Class A Medical Devices Exempted from Product Registration (currently GN-22 R8, July 2025).

Public dataset fallacy (20,860 rows are not SHARE jobs)

A 3 September 2026 extract of HSA's public Listing of Registered Medical Devices on data.gov.sg contains 20,860 listing records: 11,968 Class B, 6,296 Class C, 2,401 Class D, and 195 Class D with medicinal product. 12,629 rows have a populated change-notification approval date; 8,231 are blank. The extract describes registered SMDR listings. It does not include SHARE-job, GN-21 category, or 6Aii fields.

That approval-date column is a listing attribute — the date a change notification was last recorded as approved for that row — not a count of pending jobs. Dates in the extract span many years. It cannot support a claim that "HSA has 12,629 open CNs" or that "60% of devices are in 6Aii review." Class A devices are not in this register.

An earlier on-site census used 20,599 rows from a June 2026 extract of the same public dataset. The two counts are different extracts, not proof that one article miscounted. See the 2026 Singapore SMDR approved-devices analysis.

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GN-21 R7 30/60/90-Day SKU Map: Stop Implementing 6Aii/6Aiii on Ack, Clear the Two-CN Queue, Keep Notification Bundling Inside Six Months

This is an operational plan, not an HSA-mandated timetable.

Window	Job	Done when
Days 1–30	Stop 6Aii/6Aiii implementation on acknowledgement; census active CNs per listing	Any SKU shipped since 1 August 2026 on acknowledgement alone is on hold; listings at two active CNs are blocked for new files
Days 31–60	Close input requests; de-bundle risky composites; re-classify the pipeline against Flowchart 6A (6Ai / 6Aii / 6Aiii / 6B) and against 6C / 6E / section 2.3	Upcoming files have a category, a listing-level slot check, and Annex 1 evidence
Days 61–90	Put the R7 approval gate into the Singapore QMS annex; track the 6-month Notification clock from first global implementation	ERP/customs identifiers match the approved SMDR listing

Days 1–30. Review SKUs, pack configurations, and catalog numbers released in Singapore since 1 August 2026. If a 6Aii line extension or 6Aiii identifier went to hospital inventory on a SHARE receipt alone, hold further supply until the CN is approved. In SHARE, list every active CN against every company listing. Block new filings on listings that already have two active applications.

Days 31–60. Answer outstanding input requests so older Technical/Review files can close and free a slot. Split composite dossiers so a high-velocity listing cannot poison a static one. Pull documentary requirements from Annex 1; for technical evidence structure see the ASEAN CSDT guide and the ASEAN distributor qualification and test-report reuse matrix.

Days 61–90. Amend the Singapore country annex of change-control SOPs so 6Aii/6Aiii, 6C, and 6D cannot be released on submission receipt. Track eligible Notification items so they are filed inside six months of first global implementation — the PDF's clock, not a five-month house rule presented as law. Align warehouse and customs identifiers with the approved SMDR listing.

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What Does This Cost: Notification Is Free Versus Administrative $560 and Technical $1,890/$3,120, All Non-Refundable Once Submitted?

Separate HSA statutory fees from registrant, testing, and labelling costs.

Fee source basis: official HSA medical device fees page, last updated 26 March 2026, amounts in Singapore dollars, charged per Change Notification application. TAT on that page excludes applicant stop-clock. These figures are not a guaranteed project cost and are not converted from another currency.

Change category	Class	Official HSA fee (SGD)	Refundable if rejected?	Table 2 / fees-page TAT
Notification	B, C, D	$0	N/A	Acknowledgement
Administrative	B, C, D	$560	No	30 working days
Review	B	$560	No	45 working days
Technical	C	$1,890	No	75 working days
Technical	D	$3,120	No	90 working days
Administrative	D with registrable drug	$560	No	Contact HSA
Medicinal-product change in a Class D combination device	D	Contact HSA	No	Contact HSA

Notification remains zero on the official schedule. Administrative is SGD 560 whether the listing is Class B or Class D. Section 6 and Annex 2 together mean a two-CN rejection still forfeits whatever fee was paid. Change of registrant is a different HSA transaction (SGD 880 / 40 working days on the same fees page), not a GN-21 category.

Manufacturer-side costs still include the Singapore registrant's SHARE work, any testing needed for Annex 1, and labelling/IFU updates. Those are provider or internal costs, not HSA fees. For how registrant commercial models sit next to the government schedule, see Singapore registrant pricing.

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Frequently Asked Questions (FAQs)

Does GN-21 Revision 7 already replace Revision 6, and why does the revision history say Revision 6.1?

Yes, for new operating guidance. The August 2026 PDF is the current GN-21 file. The guidance list archived Revision 6 on 31 July 2026. Revision 6.1 (01 Aug 2026) in the page-4 history table is HSA's revision-history label for that same Revision 7 PDF, not a third instrument. Follow GN-21-R7 plus Annex 2 (August 2026).

Can we still implement 6Aii or 6Aiii SMDR listing changes when SHARE sends the acknowledgement email?

No. The page-11 Administrative paragraph requires HSA approval before implementing 6Aii/6Aiii public listing changes in Singapore. That covers same-design additions within the registered size range, pack-count changes that do not breach individual primary packaging, volume changes that do not affect specifications, repackaged combinations of existing models, and new device or software identifiers with no performance or specification change. The March 2026 HTML Implementation section is not the current rule.

Are Notification changes still implement-on-acknowledgement after 1 August 2026?

Yes, for true Notification changes. Deletions of published listing particulars (6B), UDI data-element submissions (6E), and other changes that are not Administrative, Review, or Technical — and are not exempt under section 2.3 — may still go live on the SHARE acknowledgement email. File them within 6 months of first global implementation. Do not use that clock to relabel a 6Aii addition as Notification.

What happens if we file a third change notification on a listing that already has two active CNs?

The entire application is rejected. Annex 2 allows no more than two active CNs per listing at submission. If any listing in the dossier is already at two, the whole file is rejected and fees paid are not refunded.

Do Class A devices need a GN-21 change notification?

No. Section 2.1 says Change Notification should not be submitted for Class A devices. Maintain them in the Class A Medical Device Database under GN-22: Guidance for Dealers on Class A Medical Devices Exempted from Product Registration.

Is there an HSA fee for a Notification-category change, and are rejected CN fees refunded?

Notification is SGD 0 on the 26 March 2026 HSA schedule. Administrative and Class B Review are SGD 560; Class C Technical SGD 1,890; Class D Technical SGD 3,120. Rejected and withdrawn applications do not get a refund once submitted via SHARE, including two-CN-cap rejections.

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How Pure Global Supports Singapore HSA Device Registration and Change Notifications

Managing SMDR listings, preparing SHARE Change Notification dossiers, and sequencing post-listing variations is execution work, not a PDF recitation. Pure Global provides regulatory strategy, Singapore registrant services, and submission management for manufacturers entering Singapore and the wider ASEAN corridor.

Pure Global's Singapore practice can:

• Act as qualified Singapore Registrant, keep SMDR listings current, and handle HSA correspondence.
• Classify proposed engineering and labelling changes against GN-21 Revision 7 (Notification, Administrative including 6Aii/6Aiii, Review, or Technical) instead of the March 2026 HTML Implementation bullets.
• Sequence SHARE jobs so a listing does not hit Annex 2's two-active-CN cap.
• Assemble Annex 1 / CSDT-aligned evidence so input requests do not burn a non-refundable fee.
• Quote registrant and variation work against published service pricing.

To classify a pipeline of Singapore changes or to hand SHARE filing to a registrant, contact Pure Global.

Pure Global provides professional regulatory affairs and commercial consulting. It is not the Health Sciences Authority, not a Singapore competent authority, and does not issue statutory approvals.

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Sources

1. GN-21: Guidance on Change Notification for Registered Medical Devices — Revision 7 (PDF) — Health Sciences Authority, August 2026 (revision history: Revision 6.1, 01 Aug 2026). Retrieved 7 September 2026.
2. Annex 2 to GN-21 — Summary Table of Change Notification (DOCX) — Health Sciences Authority, August 2026. Two-active-CN note. Retrieved 7 September 2026.
3. Guidance documents for medical devices — Health Sciences Authority, last updated 26 August 2026 (GN-21-R7 published; GN-21-R6 archived 31 July 2026).
4. Notify changes to registered medical devices — Health Sciences Authority, last updated 13 March 2026 (stale HTML contrast; Implementation section still lists 6Aii/6Aiii as implement-on-acknowledgement).
5. Updates to GN-21 — Health Sciences Authority, 4 July 2025 (Revision 6 announcement; MLMD Flowchart 2.5 and change type 6E).
6. Fees and turnaround time for medical devices — Health Sciences Authority, last updated 26 March 2026 (official SGD Change Notification schedule).
7. Listing of Registered Medical Devices — Health Sciences Authority / data.gov.sg. A 3 September 2026 extract of this public listing dataset had 20,860 records and 12,629 populated change-notification approval dates. Used only as a listing-inventory contrast, not a SHARE census.
8. Health Products (Medical Devices) Regulations 2010 and Health Products Act 2007, section 15 — Singapore Statutes Online.
9. Introducing SHARE — Health Sciences Authority, 23 June 2025 (SHARE = Singapore Health Product Access and Regulatory E-System).