Singapore medical device regulations

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.

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.

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.

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 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.

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.

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.

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.

SGD 560

Per application

SGD 560

Per application

SGD 1,890

Per application

SGD 560

Per application

SGD 3,120

Per application

SGD 57

Per application

SGD 57

Per device and country

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.

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.

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.

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 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.

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.

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.

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.

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.

SGD 560

Per application

SGD 560

Per application

SGD 1,890

Per application

SGD 560

Per application

SGD 3,120

Per application

SGD 57

Per application

SGD 57

Per device and country

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.

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.

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.

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 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.

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.

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.

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.

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.

SGD 560

Per application

SGD 560

Per application

SGD 1,890

Per application

SGD 560

Per application

SGD 3,120

Per application

SGD 57

Per application

SGD 57

Per device and country

GN 21 requires a new product registration for the specified intended-purpose/risk changes, added models outside grouping/permissible variants and other enumerated triggers. It additionally addresses differing proprietary names and their grouping exception. These rules apply within the MD definition expressly including IVDs. An orderable REF rename is not automatically an added model or a new device; use its actual registered identity.

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.

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.

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.

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 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.

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.

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.

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.

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.

SGD 560

Per application

SGD 560

Per application

SGD 1,890

Per application

SGD 560

Per application

SGD 3,120

Per application

SGD 57

Per application

SGD 57

Per device and country

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.

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 21 requires a new product registration for the specified intended-purpose/risk changes, added models outside grouping/permissible variants and other enumerated triggers. It additionally addresses differing proprietary names and their grouping exception. These rules apply within the MD definition expressly including IVDs. An orderable REF rename is not automatically an added model or a new device; use its actual registered identity.

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.

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.

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.

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.

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 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.

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.

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.

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.

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.

SGD 560

Per application

SGD 560

Per application

SGD 1,890

Per application

SGD 560

Per application

SGD 3,120

Per application

SGD 880

Per application

40 working-day TAT

SGD 57

Per application

SGD 57

Per device and country

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.

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 21 requires a new product registration for the specified intended-purpose/risk changes, added models outside grouping/permissible variants and other enumerated triggers. It additionally addresses differing proprietary names and their grouping exception. These rules apply within the MD definition expressly including IVDs. An orderable REF rename is not automatically an added model or a new device; use its actual registered identity.

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.

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.

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.

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.

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 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.

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.

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.

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.

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.

SGD 560

Per application

SGD 560

Per application

SGD 1,890

Per application

SGD 560

Per application

SGD 3,120

Per application

SGD 880

Per application

40 working-day TAT

SGD 57

Per application

SGD 57

Per device and country