Canada medical device regulations

Before the following changes, the manufacturer must apply for a medical device licence amendment: a significant change to a Class III or IV device; a change affecting classification; the manufacturer's name; the device name; the device identifier; or, for a Class II device other than a decorative contact lens, the medical conditions, purposes or uses for which it is manufactured, sold or represented.

Conditions

Applies to licensed Class II-IV medical devices and IVDs (not Class I); the significant-change trigger in paragraph (a) applies to Class III and IV devices.
Paragraph (e) includes an identifier of a medical device that is part of a system, test kit, medical device group, medical device family or medical device group family.
Section 26 is subject to section 37; applicable IVDD batch-licensing requirements remain separate.

Independently checked against section 34(a)-(f). This record does not establish a route for unlisted changes, permission to combine changes, a fee or a review clock.

Filing route and prior approval

Pure artwork versus a licensed-name change

Guidance for interpreting significant changes to medical devices — 2026

Section 34 separately requires an amendment before a licensed manufacturer/device-name or identifier change, even if not scientifically significant. A pure graphic edit must be assessed for significant/cumulative safety, effectiveness and labelling impact; Class III/IV significant changes need amendment. Section 43 annual reporting excludes changes separately required under 34/43.1 and cannot replace those mandatory amendments.

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.

Filing route and prior approval

Product-licence changes concern Class II-IV

MDR26 requires the manufacturer-held licence/amended licence for Class II, III and IV devices, subject to Section 37. This includes IVDDs under the definition. The Section 34 product-licence amendment answer does not impose an MDL on Class I; the applicable establishment and other obligations remain separate.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Supporting documents

REP product amendment files

Medical Devices Regulations (SOR/98-282) — consolidated text

A product regulatory transaction uses the current RT XML and AI template where that transaction type requires it, with the relevant Section 32 evidence. A device-details workbook is required if the amendment affects the catalogue listing; initial transaction attestation requirements remain. Do not file superseded licence/minor-change faxback forms alongside REP XML. Company amendments are a separate preceding process where company information changes.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Change-specific government fees

Class III/IV non-scientific amendments have no fee

The current fee guidance expressly says there is no Class III/IV amendment-application fee where scientific review is not required, with device name, identifier and manufacturer name as examples. If the actual change instead triggers a scientific amendment category, use its applicable current fee row. This exemption is not an exemption from making a required amendment, or the fee for a Class II amendment/private-label 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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Change-specific review time

Change-specific screening and first-decision targets

The 2026 management table includes Class II amendment target 15 calendar days for regulatory screening/administrative processing, minor-change regulatory screening 4 plus administrative 3 days, and significant Class III/IV review targets 60/75 calendar days from the screening-acceptance letter to first decision, including 3 administrative days. Separate initial screening and applicant-response/clock pauses apply. A company-only CO amendment is not automatically a seven-day product minor-change application.

Conditions

These are target timelines/performance standards with their stated commencement and exceptions, not guaranteed end-to-end authorisation dates.
Generic month conversions in initial-registration context are not substituted for these change-specific calendar-day figures.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Labels and identifiers

Manufacturer, device identity and language on labels

MDR21 requires the device name, manufacturer name/address, device identifier and applicable other particulars on a legible/permanent/prominent label. Section 23 permits the specified English/French arrangements and requires both languages for the stated general-public items. These shared MDR provisions include IVDDs under the definition; they are not an automatic old-label or stock-transition permission.

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

Actual device identifier rather than an assumed UDI

Section 34(e) requires amendment for the licensed identifier, including members of systems, test kits, groups and families. The statutory identifier is the manufacturer-assigned identifying series of letters, numbers or barcode. Map an orderable REF to the recorded device identifier/name and labels before selecting that route; the definition does not make every commercial REF a UDI or a new model.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Labels and identifiers

Prior-notified import relabelling is not sell-through

Sections 21.1/21.2 permit specified noncompliantly labelled imports only with prior import notice and manufacturer relabelling within three months after import, before sale; notify the relabeller identity when done on the manufacturer behalf. This is a conditional pre-sale correction route, not three months of unrestricted sale of old-brand/old-owner stock.

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 is a separate voluntary Canadian-manufacturer service

GUI0097 provides a voluntary, no-application-fee Manufacturer Certificate to Export/CFS service for eligible manufacturers located in Canada holding the appropriate MDEL/MDL/authorisation. Use current FRM0539 with actual manufacturer/device/licence and identifiers; one form may list multiple devices. Foreign-owner products merely imported for packaging/labelling are excluded. The guidance states no service standard; ordinary name/REF amendments do not themselves make every company eligible or require CFS reissue.

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

Amendment - Class II licence

CAD 331

Per amendment

Effective from 2026-04-01

Conditions for this question

Only a Class II medical-device licence amendment, including an IVDD licensed under the same MDR class regime.
Only the actual chargeable scientific-review or Class II MDL amendment branch named by this row. No automatic fee for a company-only CO update, Class III/IV non-scientific amendment, Class I device or private-label/special authorisation transaction with a different fee category. An office-only update is not a manufacturing-process/site change.

Change-specific government fees

Amendment - Class III/IV changes in manufacturing

CAD 4,470

Per amendment

Effective from 2026-04-01

Conditions for this question

Only an actual Class III/IV manufacturing-change amendment needing scientific review; an office-only change is not a factory move.
Only the actual chargeable scientific-review or Class II MDL amendment branch named by this row. No automatic fee for a company-only CO update, Class III/IV non-scientific amendment, Class I device or private-label/special authorisation transaction with a different fee category. An office-only update is not a manufacturing-process/site change.

Change-specific government fees

Amendment - Class III significant changes not related to manufacturing

CAD 11,369

Per amendment

Effective from 2026-04-01

Conditions for this question

Only the applicable Class III significant, non-manufacturing scientific amendment.
Only the actual chargeable scientific-review or Class II MDL amendment branch named by this row. No automatic fee for a company-only CO update, Class III/IV non-scientific amendment, Class I device or private-label/special authorisation transaction with a different fee category. An office-only update is not a manufacturing-process/site change.

Change-specific government fees

Amendment - Class IV significant changes not related to manufacturing

Change control →Label, IFU & language →UDI, listing & traceability →

CAD 16,251

Per amendment

Effective from 2026-04-01

Conditions for this question

Only the applicable Class IV significant, non-manufacturing scientific amendment.
Only the actual chargeable scientific-review or Class II MDL amendment branch named by this row. No automatic fee for a company-only CO update, Class III/IV non-scientific amendment, Class I device or private-label/special authorisation transaction with a different fee category. An office-only update is not a manufacturing-process/site change.

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

Filing route and prior approval ↓
Supporting documents ↓
Change-specific government fees ↓
Change-specific review time ↓
Labels and identifiers ↓
Free sale certificate impact ↓
Combined filing ↓

Read each rule with its scope and conditions.

Filing route and prior approval

Change requiring licence amendment

Before the following changes, the manufacturer must apply for a medical device licence amendment: a significant change to a Class III or IV device; a change affecting classification; the manufacturer's name; the device name; the device identifier; or, for a Class II device other than a decorative contact lens, the medical conditions, purposes or uses for which it is manufactured, sold or represented.

Conditions

Applies to licensed Class II-IV medical devices and IVDs (not Class I); the significant-change trigger in paragraph (a) applies to Class III and IV devices.
Paragraph (e) includes an identifier of a medical device that is part of a system, test kit, medical device group, medical device family or medical device group family.
Section 26 is subject to section 37; applicable IVDD batch-licensing requirements remain separate.

Independently checked against section 34(a)-(f). This record does not establish a route for unlisted changes, permission to combine changes, a fee or a review clock.

Filing route and prior approval

Pure artwork versus a licensed-name change

Guidance for interpreting significant changes to medical devices — 2026

Section 34 separately requires an amendment before a licensed manufacturer/device-name or identifier change, even if not scientifically significant. A pure graphic edit must be assessed for significant/cumulative safety, effectiveness and labelling impact; Class III/IV significant changes need amendment. Section 43 annual reporting excludes changes separately required under 34/43.1 and cannot replace those mandatory amendments.

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.

Filing route and prior approval

Company name/address and real ownership transfer

Company enrolment (CO) template — instructions and ownership-transfer fields New and amended Class II-IV medical device licences Medical Devices Regulations (SOR/98-282) — consolidated text

Current REP uses a Company (CO) amendment for manufacturer name/address, facility address and transfers of licences between manufacturers, identifying all impacted licences. Health Canada verifies the change and returns final company XML and updated licences. This replaces the legacy manufacturer-name/address faxback. A same-entity office change is not automatically a factory move; actual ownership transfer is different from a local importer/distributor change.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Filing route and prior approval

Product-licence changes concern Class II-IV

MDR26 requires the manufacturer-held licence/amended licence for Class II, III and IV devices, subject to Section 37. This includes IVDDs under the definition. The Section 34 product-licence amendment answer does not impose an MDL on Class I; the applicable establishment and other obligations remain separate.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Supporting documents

REP product amendment files

Medical Devices Regulations (SOR/98-282) — consolidated text

A product regulatory transaction uses the current RT XML and AI template where that transaction type requires it, with the relevant Section 32 evidence. A device-details workbook is required if the amendment affects the catalogue listing; initial transaction attestation requirements remain. Do not file superseded licence/minor-change faxback forms alongside REP XML. Company amendments are a separate preceding process where company information changes.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Supporting documents

Current company-amendment supporting documents

Guidance on the regulatory enrolment process for medical devices — regulatory process

The current CO instructions request each affected licence cover, updated labelling, a valid MDSAP certificate reflecting the changed manufacturer name/address, a completed F202 fee form and signed attestation as applicable. The form expressly asks whether ownership is transferred and for all affected licence numbers and rationale. Preserve the actual change-specific scope rather than requiring every certificate to be reissued for pure artwork.

Conditions

Use the current interactive F202 and attestation forms in a compatible reader; do not substitute the superseded faxback.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Change-specific government fees

Class III/IV non-scientific amendments have no fee

The current fee guidance expressly says there is no Class III/IV amendment-application fee where scientific review is not required, with device name, identifier and manufacturer name as examples. If the actual change instead triggers a scientific amendment category, use its applicable current fee row. This exemption is not an exemption from making a required amendment, or the fee for a Class II amendment/private-label 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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Change-specific review time

Change-specific screening and first-decision targets

The 2026 management table includes Class II amendment target 15 calendar days for regulatory screening/administrative processing, minor-change regulatory screening 4 plus administrative 3 days, and significant Class III/IV review targets 60/75 calendar days from the screening-acceptance letter to first decision, including 3 administrative days. Separate initial screening and applicant-response/clock pauses apply. A company-only CO amendment is not automatically a seven-day product minor-change application.

Conditions

These are target timelines/performance standards with their stated commencement and exceptions, not guaranteed end-to-end authorisation dates.
Generic month conversions in initial-registration context are not substituted for these change-specific calendar-day figures.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Labels and identifiers

Manufacturer, device identity and language on labels

MDR21 requires the device name, manufacturer name/address, device identifier and applicable other particulars on a legible/permanent/prominent label. Section 23 permits the specified English/French arrangements and requires both languages for the stated general-public items. These shared MDR provisions include IVDDs under the definition; they are not an automatic old-label or stock-transition permission.

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

Actual device identifier rather than an assumed UDI

Section 34(e) requires amendment for the licensed identifier, including members of systems, test kits, groups and families. The statutory identifier is the manufacturer-assigned identifying series of letters, numbers or barcode. Map an orderable REF to the recorded device identifier/name and labels before selecting that route; the definition does not make every commercial REF a UDI or a new model.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Labels and identifiers

Prior-notified import relabelling is not sell-through

Sections 21.1/21.2 permit specified noncompliantly labelled imports only with prior import notice and manufacturer relabelling within three months after import, before sale; notify the relabeller identity when done on the manufacturer behalf. This is a conditional pre-sale correction route, not three months of unrestricted sale of old-brand/old-owner stock.

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 is a separate voluntary Canadian-manufacturer service

GUI0097 provides a voluntary, no-application-fee Manufacturer Certificate to Export/CFS service for eligible manufacturers located in Canada holding the appropriate MDEL/MDL/authorisation. Use current FRM0539 with actual manufacturer/device/licence and identifiers; one form may list multiple devices. Foreign-owner products merely imported for packaging/labelling are excluded. The guidance states no service standard; ordinary name/REF amendments do not themselves make every company eligible or require CFS reissue.

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

Complete company amendment before the product transaction

If company information changes and a regulatory transaction is needed, complete CO enrolment/amendment first because Health Canada may assign a new company ID. The guidance describes up to five business days for processing but also asks companies to allow a minimum seven business days; retain both statements. Neither is a universal product-amendment review period nor permission to merge the company and product transactions.

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.
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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Change-specific government fees

Amendment - Class II licence

CAD 331

Per amendment

Effective from 2026-04-01

Conditions for this question

Only a Class II medical-device licence amendment, including an IVDD licensed under the same MDR class regime.
Only the actual chargeable scientific-review or Class II MDL amendment branch named by this row. No automatic fee for a company-only CO update, Class III/IV non-scientific amendment, Class I device or private-label/special authorisation transaction with a different fee category. An office-only update is not a manufacturing-process/site change.

Change-specific government fees

Amendment - Class III/IV changes in manufacturing

CAD 4,470

Per amendment

Effective from 2026-04-01

Conditions for this question

Only an actual Class III/IV manufacturing-change amendment needing scientific review; an office-only change is not a factory move.
Only the actual chargeable scientific-review or Class II MDL amendment branch named by this row. No automatic fee for a company-only CO update, Class III/IV non-scientific amendment, Class I device or private-label/special authorisation transaction with a different fee category. An office-only update is not a manufacturing-process/site change.

Change-specific government fees

Amendment - Class III significant changes not related to manufacturing

CAD 11,369

Per amendment

Effective from 2026-04-01

Conditions for this question

Only the applicable Class III significant, non-manufacturing scientific amendment.
Only the actual chargeable scientific-review or Class II MDL amendment branch named by this row. No automatic fee for a company-only CO update, Class III/IV non-scientific amendment, Class I device or private-label/special authorisation transaction with a different fee category. An office-only update is not a manufacturing-process/site change.

Change-specific government fees

Amendment - Class IV significant changes not related to manufacturing

Change control →Economic-operator roles →Label, IFU & language →

CAD 16,251

Per amendment

Effective from 2026-04-01

Conditions for this question

Only the applicable Class IV significant, non-manufacturing scientific amendment.
Only the actual chargeable scientific-review or Class II MDL amendment branch named by this row. No automatic fee for a company-only CO update, Class III/IV non-scientific amendment, Class I device or private-label/special authorisation transaction with a different fee category. An office-only update is not a manufacturing-process/site change.

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

Filing route and prior approval ↓
Supporting documents ↓
Change-specific government fees ↓
Change-specific review time ↓
Labels and identifiers ↓
Free sale certificate impact ↓
Combined filing ↓

Read each rule with its scope and conditions.

Filing route and prior approval

Change requiring licence amendment

Before the following changes, the manufacturer must apply for a medical device licence amendment: a significant change to a Class III or IV device; a change affecting classification; the manufacturer's name; the device name; the device identifier; or, for a Class II device other than a decorative contact lens, the medical conditions, purposes or uses for which it is manufactured, sold or represented.

Conditions

Applies to licensed Class II-IV medical devices and IVDs (not Class I); the significant-change trigger in paragraph (a) applies to Class III and IV devices.
Paragraph (e) includes an identifier of a medical device that is part of a system, test kit, medical device group, medical device family or medical device group family.
Section 26 is subject to section 37; applicable IVDD batch-licensing requirements remain separate.

Independently checked against section 34(a)-(f). This record does not establish a route for unlisted changes, permission to combine changes, a fee or a review clock.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Filing route and prior approval

Pure artwork versus a licensed-name change

Guidance for interpreting significant changes to medical devices — 2026

Section 34 separately requires an amendment before a licensed manufacturer/device-name or identifier change, even if not scientifically significant. A pure graphic edit must be assessed for significant/cumulative safety, effectiveness and labelling impact; Class III/IV significant changes need amendment. Section 43 annual reporting excludes changes separately required under 34/43.1 and cannot replace those mandatory amendments.

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.

Filing route and prior approval

Company name/address and real ownership transfer

Company enrolment (CO) template — instructions and ownership-transfer fields New and amended Class II-IV medical device licences Medical Devices Regulations (SOR/98-282) — consolidated text

Current REP uses a Company (CO) amendment for manufacturer name/address, facility address and transfers of licences between manufacturers, identifying all impacted licences. Health Canada verifies the change and returns final company XML and updated licences. This replaces the legacy manufacturer-name/address faxback. A same-entity office change is not automatically a factory move; actual ownership transfer is different from a local importer/distributor change.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Filing route and prior approval

Product-licence changes concern Class II-IV

MDR26 requires the manufacturer-held licence/amended licence for Class II, III and IV devices, subject to Section 37. This includes IVDDs under the definition. The Section 34 product-licence amendment answer does not impose an MDL on Class I; the applicable establishment and other obligations remain separate.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Supporting documents

REP product amendment files

Medical Devices Regulations (SOR/98-282) — consolidated text

A product regulatory transaction uses the current RT XML and AI template where that transaction type requires it, with the relevant Section 32 evidence. A device-details workbook is required if the amendment affects the catalogue listing; initial transaction attestation requirements remain. Do not file superseded licence/minor-change faxback forms alongside REP XML. Company amendments are a separate preceding process where company information changes.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Supporting documents

Current company-amendment supporting documents

Guidance on the regulatory enrolment process for medical devices — regulatory process

The current CO instructions request each affected licence cover, updated labelling, a valid MDSAP certificate reflecting the changed manufacturer name/address, a completed F202 fee form and signed attestation as applicable. The form expressly asks whether ownership is transferred and for all affected licence numbers and rationale. Preserve the actual change-specific scope rather than requiring every certificate to be reissued for pure artwork.

Conditions

Use the current interactive F202 and attestation forms in a compatible reader; do not substitute the superseded faxback.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Change-specific government fees

Class III/IV non-scientific amendments have no fee

The current fee guidance expressly says there is no Class III/IV amendment-application fee where scientific review is not required, with device name, identifier and manufacturer name as examples. If the actual change instead triggers a scientific amendment category, use its applicable current fee row. This exemption is not an exemption from making a required amendment, or the fee for a Class II amendment/private-label 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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Change-specific review time

Change-specific screening and first-decision targets

The 2026 management table includes Class II amendment target 15 calendar days for regulatory screening/administrative processing, minor-change regulatory screening 4 plus administrative 3 days, and significant Class III/IV review targets 60/75 calendar days from the screening-acceptance letter to first decision, including 3 administrative days. Separate initial screening and applicant-response/clock pauses apply. A company-only CO amendment is not automatically a seven-day product minor-change application.

Conditions

These are target timelines/performance standards with their stated commencement and exceptions, not guaranteed end-to-end authorisation dates.
Generic month conversions in initial-registration context are not substituted for these change-specific calendar-day figures.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Labels and identifiers

Manufacturer, device identity and language on labels

MDR21 requires the device name, manufacturer name/address, device identifier and applicable other particulars on a legible/permanent/prominent label. Section 23 permits the specified English/French arrangements and requires both languages for the stated general-public items. These shared MDR provisions include IVDDs under the definition; they are not an automatic old-label or stock-transition permission.

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

Actual device identifier rather than an assumed UDI

Section 34(e) requires amendment for the licensed identifier, including members of systems, test kits, groups and families. The statutory identifier is the manufacturer-assigned identifying series of letters, numbers or barcode. Map an orderable REF to the recorded device identifier/name and labels before selecting that route; the definition does not make every commercial REF a UDI or a new model.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Labels and identifiers

Prior-notified import relabelling is not sell-through

Sections 21.1/21.2 permit specified noncompliantly labelled imports only with prior import notice and manufacturer relabelling within three months after import, before sale; notify the relabeller identity when done on the manufacturer behalf. This is a conditional pre-sale correction route, not three months of unrestricted sale of old-brand/old-owner stock.

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 is a separate voluntary Canadian-manufacturer service

GUI0097 provides a voluntary, no-application-fee Manufacturer Certificate to Export/CFS service for eligible manufacturers located in Canada holding the appropriate MDEL/MDL/authorisation. Use current FRM0539 with actual manufacturer/device/licence and identifiers; one form may list multiple devices. Foreign-owner products merely imported for packaging/labelling are excluded. The guidance states no service standard; ordinary name/REF amendments do not themselves make every company eligible or require CFS reissue.

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

Complete company amendment before the product transaction

If company information changes and a regulatory transaction is needed, complete CO enrolment/amendment first because Health Canada may assign a new company ID. The guidance describes up to five business days for processing but also asks companies to allow a minimum seven business days; retain both statements. Neither is a universal product-amendment review period nor permission to merge the company and product transactions.

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.
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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Change-specific government fees

Amendment - Class II licence

CAD 331

Per amendment

Effective from 2026-04-01

Conditions for this question

Only a Class II medical-device licence amendment, including an IVDD licensed under the same MDR class regime.
Only the actual chargeable scientific-review or Class II MDL amendment branch named by this row. No automatic fee for a company-only CO update, Class III/IV non-scientific amendment, Class I device or private-label/special authorisation transaction with a different fee category. An office-only update is not a manufacturing-process/site change.

Change-specific government fees

Amendment - Class III/IV changes in manufacturing

CAD 4,470

Per amendment

Effective from 2026-04-01

Conditions for this question

Only an actual Class III/IV manufacturing-change amendment needing scientific review; an office-only change is not a factory move.
Only the actual chargeable scientific-review or Class II MDL amendment branch named by this row. No automatic fee for a company-only CO update, Class III/IV non-scientific amendment, Class I device or private-label/special authorisation transaction with a different fee category. An office-only update is not a manufacturing-process/site change.

Change-specific government fees

Amendment - Class III significant changes not related to manufacturing

CAD 11,369

Per amendment

Effective from 2026-04-01

Conditions for this question

Only the applicable Class III significant, non-manufacturing scientific amendment.
Only the actual chargeable scientific-review or Class II MDL amendment branch named by this row. No automatic fee for a company-only CO update, Class III/IV non-scientific amendment, Class I device or private-label/special authorisation transaction with a different fee category. An office-only update is not a manufacturing-process/site change.

Change-specific government fees

Amendment - Class IV significant changes not related to manufacturing

Change control →Economic-operator roles →Label, IFU & language →

CAD 16,251

Per amendment

Effective from 2026-04-01

Conditions for this question

Only the applicable Class IV significant, non-manufacturing scientific amendment.
Only the actual chargeable scientific-review or Class II MDL amendment branch named by this row. No automatic fee for a company-only CO update, Class III/IV non-scientific amendment, Class I device or private-label/special authorisation transaction with a different fee category. An office-only update is not a manufacturing-process/site change.

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

Filing route and prior approval ↓
Supporting documents ↓
Change-specific government fees ↓
Change-specific review time ↓
Labels and identifiers ↓
Combined filing ↓
Free sale certificate impact ↓

Read each rule with its scope and conditions.

Filing route and prior approval

Change requiring licence amendment

Before the following changes, the manufacturer must apply for a medical device licence amendment: a significant change to a Class III or IV device; a change affecting classification; the manufacturer's name; the device name; the device identifier; or, for a Class II device other than a decorative contact lens, the medical conditions, purposes or uses for which it is manufactured, sold or represented.

Conditions

Applies to licensed Class II-IV medical devices and IVDs (not Class I); the significant-change trigger in paragraph (a) applies to Class III and IV devices.
Paragraph (e) includes an identifier of a medical device that is part of a system, test kit, medical device group, medical device family or medical device group family.
Section 26 is subject to section 37; applicable IVDD batch-licensing requirements remain separate.

Independently checked against section 34(a)-(f). This record does not establish a route for unlisted changes, permission to combine changes, a fee or a review clock.

Filing route and prior approval

Pure artwork versus a licensed-name change

Guidance for interpreting significant changes to medical devices — 2026

Section 34 separately requires an amendment before a licensed manufacturer/device-name or identifier change, even if not scientifically significant. A pure graphic edit must be assessed for significant/cumulative safety, effectiveness and labelling impact; Class III/IV significant changes need amendment. Section 43 annual reporting excludes changes separately required under 34/43.1 and cannot replace those mandatory amendments.

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.

Filing route and prior approval

Company name/address and real ownership transfer

Company enrolment (CO) template — instructions and ownership-transfer fields New and amended Class II-IV medical device licences Medical Devices Regulations (SOR/98-282) — consolidated text

Current REP uses a Company (CO) amendment for manufacturer name/address, facility address and transfers of licences between manufacturers, identifying all impacted licences. Health Canada verifies the change and returns final company XML and updated licences. This replaces the legacy manufacturer-name/address faxback. A same-entity office change is not automatically a factory move; actual ownership transfer is different from a local importer/distributor change.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Filing route and prior approval
Labels and identifiers

Actual device identifier rather than an assumed UDI

Section 34(e) requires amendment for the licensed identifier, including members of systems, test kits, groups and families. The statutory identifier is the manufacturer-assigned identifying series of letters, numbers or barcode. Map an orderable REF to the recorded device identifier/name and labels before selecting that route; the definition does not make every commercial REF a UDI or a new model.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Filing route and prior approval

Product-licence changes concern Class II-IV

MDR26 requires the manufacturer-held licence/amended licence for Class II, III and IV devices, subject to Section 37. This includes IVDDs under the definition. The Section 34 product-licence amendment answer does not impose an MDL on Class I; the applicable establishment and other obligations remain separate.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Supporting documents

REP product amendment files

Medical Devices Regulations (SOR/98-282) — consolidated text

A product regulatory transaction uses the current RT XML and AI template where that transaction type requires it, with the relevant Section 32 evidence. A device-details workbook is required if the amendment affects the catalogue listing; initial transaction attestation requirements remain. Do not file superseded licence/minor-change faxback forms alongside REP XML. Company amendments are a separate preceding process where company information changes.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Supporting documents

Current company-amendment supporting documents

Guidance on the regulatory enrolment process for medical devices — regulatory process

The current CO instructions request each affected licence cover, updated labelling, a valid MDSAP certificate reflecting the changed manufacturer name/address, a completed F202 fee form and signed attestation as applicable. The form expressly asks whether ownership is transferred and for all affected licence numbers and rationale. Preserve the actual change-specific scope rather than requiring every certificate to be reissued for pure artwork.

Conditions

Use the current interactive F202 and attestation forms in a compatible reader; do not substitute the superseded faxback.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Change-specific government fees

Class III/IV non-scientific amendments have no fee

The current fee guidance expressly says there is no Class III/IV amendment-application fee where scientific review is not required, with device name, identifier and manufacturer name as examples. If the actual change instead triggers a scientific amendment category, use its applicable current fee row. This exemption is not an exemption from making a required amendment, or the fee for a Class II amendment/private-label 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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Change-specific review time

Change-specific screening and first-decision targets

The 2026 management table includes Class II amendment target 15 calendar days for regulatory screening/administrative processing, minor-change regulatory screening 4 plus administrative 3 days, and significant Class III/IV review targets 60/75 calendar days from the screening-acceptance letter to first decision, including 3 administrative days. Separate initial screening and applicant-response/clock pauses apply. A company-only CO amendment is not automatically a seven-day product minor-change application.

Conditions

These are target timelines/performance standards with their stated commencement and exceptions, not guaranteed end-to-end authorisation dates.
Generic month conversions in initial-registration context are not substituted for these change-specific calendar-day figures.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Labels and identifiers

Manufacturer, device identity and language on labels

MDR21 requires the device name, manufacturer name/address, device identifier and applicable other particulars on a legible/permanent/prominent label. Section 23 permits the specified English/French arrangements and requires both languages for the stated general-public items. These shared MDR provisions include IVDDs under the definition; they are not an automatic old-label or stock-transition permission.

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

Prior-notified import relabelling is not sell-through

Sections 21.1/21.2 permit specified noncompliantly labelled imports only with prior import notice and manufacturer relabelling within three months after import, before sale; notify the relabeller identity when done on the manufacturer behalf. This is a conditional pre-sale correction route, not three months of unrestricted sale of old-brand/old-owner stock.

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 is a separate voluntary Canadian-manufacturer service

GUI0097 provides a voluntary, no-application-fee Manufacturer Certificate to Export/CFS service for eligible manufacturers located in Canada holding the appropriate MDEL/MDL/authorisation. Use current FRM0539 with actual manufacturer/device/licence and identifiers; one form may list multiple devices. Foreign-owner products merely imported for packaging/labelling are excluded. The guidance states no service standard; ordinary name/REF amendments do not themselves make every company eligible or require CFS reissue.

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

Complete company amendment before the product transaction

If company information changes and a regulatory transaction is needed, complete CO enrolment/amendment first because Health Canada may assign a new company ID. The guidance describes up to five business days for processing but also asks companies to allow a minimum seven business days; retain both statements. Neither is a universal product-amendment review period nor permission to merge the company and product transactions.

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.
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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Change-specific government fees

Amendment - Class II licence

CAD 331

Per amendment

Effective from 2026-04-01

Conditions for this question

Only a Class II medical-device licence amendment, including an IVDD licensed under the same MDR class regime.
Only the actual chargeable scientific-review or Class II MDL amendment branch named by this row. No automatic fee for a company-only CO update, Class III/IV non-scientific amendment, Class I device or private-label/special authorisation transaction with a different fee category. An office-only update is not a manufacturing-process/site change.

Change-specific government fees

Amendment - Class III/IV changes in manufacturing

CAD 4,470

Per amendment

Effective from 2026-04-01

Conditions for this question

Only an actual Class III/IV manufacturing-change amendment needing scientific review; an office-only change is not a factory move.
Only the actual chargeable scientific-review or Class II MDL amendment branch named by this row. No automatic fee for a company-only CO update, Class III/IV non-scientific amendment, Class I device or private-label/special authorisation transaction with a different fee category. An office-only update is not a manufacturing-process/site change.

Change-specific government fees

Amendment - Class III significant changes not related to manufacturing

CAD 11,369

Per amendment

Effective from 2026-04-01

Conditions for this question

Only the applicable Class III significant, non-manufacturing scientific amendment.
Only the actual chargeable scientific-review or Class II MDL amendment branch named by this row. No automatic fee for a company-only CO update, Class III/IV non-scientific amendment, Class I device or private-label/special authorisation transaction with a different fee category. An office-only update is not a manufacturing-process/site change.

Change-specific government fees

Amendment - Class IV significant changes not related to manufacturing

Change control →UDI, listing & traceability →Label, IFU & language →

CAD 16,251

Per amendment

Effective from 2026-04-01

Conditions for this question

Only the applicable Class IV significant, non-manufacturing scientific amendment.
Only the actual chargeable scientific-review or Class II MDL amendment branch named by this row. No automatic fee for a company-only CO update, Class III/IV non-scientific amendment, Class I device or private-label/special authorisation transaction with a different fee category. An office-only update is not a manufacturing-process/site change.

Can a registration transfer to a different legal entity?

A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.

Verified guidance on

Filing route and prior approval ↓
Supporting documents ↓
Change-specific government fees ↓
Change-specific review time ↓
Labels and identifiers ↓
Existing stock and transition ↓
Free sale certificate impact ↓
Combined filing ↓

Read each rule with its scope and conditions.

Filing route and prior approval

Change requiring licence amendment

Before the following changes, the manufacturer must apply for a medical device licence amendment: a significant change to a Class III or IV device; a change affecting classification; the manufacturer's name; the device name; the device identifier; or, for a Class II device other than a decorative contact lens, the medical conditions, purposes or uses for which it is manufactured, sold or represented.

Conditions

Applies to licensed Class II-IV medical devices and IVDs (not Class I); the significant-change trigger in paragraph (a) applies to Class III and IV devices.
Paragraph (e) includes an identifier of a medical device that is part of a system, test kit, medical device group, medical device family or medical device group family.
Section 26 is subject to section 37; applicable IVDD batch-licensing requirements remain separate.

Independently checked against section 34(a)-(f). This record does not establish a route for unlisted changes, permission to combine changes, a fee or a review clock.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Filing route and prior approval

Pure artwork versus a licensed-name change

Guidance for interpreting significant changes to medical devices — 2026

Section 34 separately requires an amendment before a licensed manufacturer/device-name or identifier change, even if not scientifically significant. A pure graphic edit must be assessed for significant/cumulative safety, effectiveness and labelling impact; Class III/IV significant changes need amendment. Section 43 annual reporting excludes changes separately required under 34/43.1 and cannot replace those mandatory amendments.

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.

Filing route and prior approval

Company name/address and real ownership transfer

Company enrolment (CO) template — instructions and ownership-transfer fields New and amended Class II-IV medical device licences Medical Devices Regulations (SOR/98-282) — consolidated text

Current REP uses a Company (CO) amendment for manufacturer name/address, facility address and transfers of licences between manufacturers, identifying all impacted licences. Health Canada verifies the change and returns final company XML and updated licences. This replaces the legacy manufacturer-name/address faxback. A same-entity office change is not automatically a factory move; actual ownership transfer is different from a local importer/distributor change.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Filing route and prior approval

Product-licence changes concern Class II-IV

MDR26 requires the manufacturer-held licence/amended licence for Class II, III and IV devices, subject to Section 37. This includes IVDDs under the definition. The Section 34 product-licence amendment answer does not impose an MDL on Class I; the applicable establishment and other obligations remain separate.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Supporting documents

REP product amendment files

Medical Devices Regulations (SOR/98-282) — consolidated text

A product regulatory transaction uses the current RT XML and AI template where that transaction type requires it, with the relevant Section 32 evidence. A device-details workbook is required if the amendment affects the catalogue listing; initial transaction attestation requirements remain. Do not file superseded licence/minor-change faxback forms alongside REP XML. Company amendments are a separate preceding process where company information changes.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Supporting documents

Current company-amendment supporting documents

Guidance on the regulatory enrolment process for medical devices — regulatory process

The current CO instructions request each affected licence cover, updated labelling, a valid MDSAP certificate reflecting the changed manufacturer name/address, a completed F202 fee form and signed attestation as applicable. The form expressly asks whether ownership is transferred and for all affected licence numbers and rationale. Preserve the actual change-specific scope rather than requiring every certificate to be reissued for pure artwork.

Conditions

Use the current interactive F202 and attestation forms in a compatible reader; do not substitute the superseded faxback.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Change-specific government fees

Class III/IV non-scientific amendments have no fee

The current fee guidance expressly says there is no Class III/IV amendment-application fee where scientific review is not required, with device name, identifier and manufacturer name as examples. If the actual change instead triggers a scientific amendment category, use its applicable current fee row. This exemption is not an exemption from making a required amendment, or the fee for a Class II amendment/private-label 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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Change-specific review time

Change-specific screening and first-decision targets

The 2026 management table includes Class II amendment target 15 calendar days for regulatory screening/administrative processing, minor-change regulatory screening 4 plus administrative 3 days, and significant Class III/IV review targets 60/75 calendar days from the screening-acceptance letter to first decision, including 3 administrative days. Separate initial screening and applicant-response/clock pauses apply. A company-only CO amendment is not automatically a seven-day product minor-change application.

Conditions

These are target timelines/performance standards with their stated commencement and exceptions, not guaranteed end-to-end authorisation dates.
Generic month conversions in initial-registration context are not substituted for these change-specific calendar-day figures.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Labels and identifiers

Manufacturer, device identity and language on labels

MDR21 requires the device name, manufacturer name/address, device identifier and applicable other particulars on a legible/permanent/prominent label. Section 23 permits the specified English/French arrangements and requires both languages for the stated general-public items. These shared MDR provisions include IVDDs under the definition; they are not an automatic old-label or stock-transition permission.

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

Actual device identifier rather than an assumed UDI

Section 34(e) requires amendment for the licensed identifier, including members of systems, test kits, groups and families. The statutory identifier is the manufacturer-assigned identifying series of letters, numbers or barcode. Map an orderable REF to the recorded device identifier/name and labels before selecting that route; the definition does not make every commercial REF a UDI or a new model.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Labels and identifiers

Prior-notified import relabelling is not sell-through

Sections 21.1/21.2 permit specified noncompliantly labelled imports only with prior import notice and manufacturer relabelling within three months after import, before sale; notify the relabeller identity when done on the manufacturer behalf. This is a conditional pre-sale correction route, not three months of unrestricted sale of old-brand/old-owner stock.

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

Former owner cannot continue selling transferred devices

The current implementation guidance says that once the manufacturer-name change associated with changed ownership is processed, the previous manufacturer must stop selling the devices for which ownership changed. Apply that express ownership condition; it is not a rule that a same legal person disappears after a spelling/name update or a general stock-destruction rule.

Conditions

Trace the actual licence ownership and the party making the sale.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Free sale certificate impact

CFS is a separate voluntary Canadian-manufacturer service

GUI0097 provides a voluntary, no-application-fee Manufacturer Certificate to Export/CFS service for eligible manufacturers located in Canada holding the appropriate MDEL/MDL/authorisation. Use current FRM0539 with actual manufacturer/device/licence and identifiers; one form may list multiple devices. Foreign-owner products merely imported for packaging/labelling are excluded. The guidance states no service standard; ordinary name/REF amendments do not themselves make every company eligible or require CFS reissue.

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

Complete company amendment before the product transaction

If company information changes and a regulatory transaction is needed, complete CO enrolment/amendment first because Health Canada may assign a new company ID. The guidance describes up to five business days for processing but also asks companies to allow a minimum seven business days; retain both statements. Neither is a universal product-amendment review period nor permission to merge the company and product transactions.

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.
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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Change-specific government fees

Amendment - Class II licence

CAD 331

Per amendment

Effective from 2026-04-01

Conditions for this question

Only a Class II medical-device licence amendment, including an IVDD licensed under the same MDR class regime.
Only the actual chargeable scientific-review or Class II MDL amendment branch named by this row. No automatic fee for a company-only CO update, Class III/IV non-scientific amendment, Class I device or private-label/special authorisation transaction with a different fee category. An office-only update is not a manufacturing-process/site change.

Change-specific government fees

Amendment - Class III/IV changes in manufacturing

CAD 4,470

Per amendment

Effective from 2026-04-01

Conditions for this question

Only an actual Class III/IV manufacturing-change amendment needing scientific review; an office-only change is not a factory move.
Only the actual chargeable scientific-review or Class II MDL amendment branch named by this row. No automatic fee for a company-only CO update, Class III/IV non-scientific amendment, Class I device or private-label/special authorisation transaction with a different fee category. An office-only update is not a manufacturing-process/site change.

Change-specific government fees

Amendment - Class III significant changes not related to manufacturing

CAD 11,369

Per amendment

Effective from 2026-04-01

Conditions for this question

Only the applicable Class III significant, non-manufacturing scientific amendment.
Only the actual chargeable scientific-review or Class II MDL amendment branch named by this row. No automatic fee for a company-only CO update, Class III/IV non-scientific amendment, Class I device or private-label/special authorisation transaction with a different fee category. An office-only update is not a manufacturing-process/site change.

Change-specific government fees

Amendment - Class IV significant changes not related to manufacturing

Change control →Economic-operator roles →

CAD 16,251

Per amendment

Effective from 2026-04-01

Conditions for this question

Only the applicable Class IV significant, non-manufacturing scientific amendment.
Only the actual chargeable scientific-review or Class II MDL amendment branch named by this row. No automatic fee for a company-only CO update, Class III/IV non-scientific amendment, Class I device or private-label/special authorisation transaction with a different fee category. An office-only update is not a manufacturing-process/site change.

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

Combined filing ↓
Filing route and prior approval ↓
Supporting documents ↓
Change-specific government fees ↓
Change-specific review time ↓
Labels and identifiers ↓
Existing stock and transition ↓
Free sale certificate impact ↓

Read each rule with its scope and conditions.

Filing route and prior approval

Change requiring licence amendment

Before the following changes, the manufacturer must apply for a medical device licence amendment: a significant change to a Class III or IV device; a change affecting classification; the manufacturer's name; the device name; the device identifier; or, for a Class II device other than a decorative contact lens, the medical conditions, purposes or uses for which it is manufactured, sold or represented.

Conditions

Applies to licensed Class II-IV medical devices and IVDs (not Class I); the significant-change trigger in paragraph (a) applies to Class III and IV devices.
Paragraph (e) includes an identifier of a medical device that is part of a system, test kit, medical device group, medical device family or medical device group family.
Section 26 is subject to section 37; applicable IVDD batch-licensing requirements remain separate.

Independently checked against section 34(a)-(f). This record does not establish a route for unlisted changes, permission to combine changes, a fee or a review clock.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Filing route and prior approval

Pure artwork versus a licensed-name change

Guidance for interpreting significant changes to medical devices — 2026

Section 34 separately requires an amendment before a licensed manufacturer/device-name or identifier change, even if not scientifically significant. A pure graphic edit must be assessed for significant/cumulative safety, effectiveness and labelling impact; Class III/IV significant changes need amendment. Section 43 annual reporting excludes changes separately required under 34/43.1 and cannot replace those mandatory amendments.

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.

Filing route and prior approval

Company name/address and real ownership transfer

Company enrolment (CO) template — instructions and ownership-transfer fields New and amended Class II-IV medical device licences Medical Devices Regulations (SOR/98-282) — consolidated text

Current REP uses a Company (CO) amendment for manufacturer name/address, facility address and transfers of licences between manufacturers, identifying all impacted licences. Health Canada verifies the change and returns final company XML and updated licences. This replaces the legacy manufacturer-name/address faxback. A same-entity office change is not automatically a factory move; actual ownership transfer is different from a local importer/distributor change.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Filing route and prior approval
Labels and identifiers

Actual device identifier rather than an assumed UDI

Section 34(e) requires amendment for the licensed identifier, including members of systems, test kits, groups and families. The statutory identifier is the manufacturer-assigned identifying series of letters, numbers or barcode. Map an orderable REF to the recorded device identifier/name and labels before selecting that route; the definition does not make every commercial REF a UDI or a new model.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Filing route and prior approval

Product-licence changes concern Class II-IV

MDR26 requires the manufacturer-held licence/amended licence for Class II, III and IV devices, subject to Section 37. This includes IVDDs under the definition. The Section 34 product-licence amendment answer does not impose an MDL on Class I; the applicable establishment and other obligations remain separate.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Supporting documents

REP product amendment files

Medical Devices Regulations (SOR/98-282) — consolidated text

A product regulatory transaction uses the current RT XML and AI template where that transaction type requires it, with the relevant Section 32 evidence. A device-details workbook is required if the amendment affects the catalogue listing; initial transaction attestation requirements remain. Do not file superseded licence/minor-change faxback forms alongside REP XML. Company amendments are a separate preceding process where company information changes.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Supporting documents

Current company-amendment supporting documents

Guidance on the regulatory enrolment process for medical devices — regulatory process

The current CO instructions request each affected licence cover, updated labelling, a valid MDSAP certificate reflecting the changed manufacturer name/address, a completed F202 fee form and signed attestation as applicable. The form expressly asks whether ownership is transferred and for all affected licence numbers and rationale. Preserve the actual change-specific scope rather than requiring every certificate to be reissued for pure artwork.

Conditions

Use the current interactive F202 and attestation forms in a compatible reader; do not substitute the superseded faxback.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Change-specific government fees

Class III/IV non-scientific amendments have no fee

The current fee guidance expressly says there is no Class III/IV amendment-application fee where scientific review is not required, with device name, identifier and manufacturer name as examples. If the actual change instead triggers a scientific amendment category, use its applicable current fee row. This exemption is not an exemption from making a required amendment, or the fee for a Class II amendment/private-label 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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Change-specific review time

Change-specific screening and first-decision targets

The 2026 management table includes Class II amendment target 15 calendar days for regulatory screening/administrative processing, minor-change regulatory screening 4 plus administrative 3 days, and significant Class III/IV review targets 60/75 calendar days from the screening-acceptance letter to first decision, including 3 administrative days. Separate initial screening and applicant-response/clock pauses apply. A company-only CO amendment is not automatically a seven-day product minor-change application.

Conditions

These are target timelines/performance standards with their stated commencement and exceptions, not guaranteed end-to-end authorisation dates.
Generic month conversions in initial-registration context are not substituted for these change-specific calendar-day figures.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Labels and identifiers

Manufacturer, device identity and language on labels

MDR21 requires the device name, manufacturer name/address, device identifier and applicable other particulars on a legible/permanent/prominent label. Section 23 permits the specified English/French arrangements and requires both languages for the stated general-public items. These shared MDR provisions include IVDDs under the definition; they are not an automatic old-label or stock-transition permission.

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

Prior-notified import relabelling is not sell-through

Sections 21.1/21.2 permit specified noncompliantly labelled imports only with prior import notice and manufacturer relabelling within three months after import, before sale; notify the relabeller identity when done on the manufacturer behalf. This is a conditional pre-sale correction route, not three months of unrestricted sale of old-brand/old-owner stock.

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

Former owner cannot continue selling transferred devices

The current implementation guidance says that once the manufacturer-name change associated with changed ownership is processed, the previous manufacturer must stop selling the devices for which ownership changed. Apply that express ownership condition; it is not a rule that a same legal person disappears after a spelling/name update or a general stock-destruction rule.

Conditions

Trace the actual licence ownership and the party making the sale.

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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Free sale certificate impact

CFS is a separate voluntary Canadian-manufacturer service

GUI0097 provides a voluntary, no-application-fee Manufacturer Certificate to Export/CFS service for eligible manufacturers located in Canada holding the appropriate MDEL/MDL/authorisation. Use current FRM0539 with actual manufacturer/device/licence and identifiers; one form may list multiple devices. Foreign-owner products merely imported for packaging/labelling are excluded. The guidance states no service standard; ordinary name/REF amendments do not themselves make every company eligible or require CFS reissue.

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

Complete company amendment before the product transaction

If company information changes and a regulatory transaction is needed, complete CO enrolment/amendment first because Health Canada may assign a new company ID. The guidance describes up to five business days for processing but also asks companies to allow a minimum seven business days; retain both statements. Neither is a universal product-amendment review period nor permission to merge the company and product transactions.

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.
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.
The product MDL/amendment portion applies only to licensed Class II–IV devices including applicable IVDDs; it does not impose a product MDL on Class I. Apply the actual CO/product transaction trigger.

Change-specific government fees

Amendment - Class II licence

CAD 331

Per amendment

Effective from 2026-04-01

Conditions for this question

Only a Class II medical-device licence amendment, including an IVDD licensed under the same MDR class regime.
Only the actual chargeable scientific-review or Class II MDL amendment branch named by this row. No automatic fee for a company-only CO update, Class III/IV non-scientific amendment, Class I device or private-label/special authorisation transaction with a different fee category. An office-only update is not a manufacturing-process/site change.

Change-specific government fees

Amendment - Class III/IV changes in manufacturing

CAD 4,470

Per amendment

Effective from 2026-04-01

Conditions for this question

Only an actual Class III/IV manufacturing-change amendment needing scientific review; an office-only change is not a factory move.
Only the actual chargeable scientific-review or Class II MDL amendment branch named by this row. No automatic fee for a company-only CO update, Class III/IV non-scientific amendment, Class I device or private-label/special authorisation transaction with a different fee category. An office-only update is not a manufacturing-process/site change.

Change-specific government fees

Amendment - Class III significant changes not related to manufacturing

CAD 11,369

Per amendment

Effective from 2026-04-01

Conditions for this question

Only the applicable Class III significant, non-manufacturing scientific amendment.
Only the actual chargeable scientific-review or Class II MDL amendment branch named by this row. No automatic fee for a company-only CO update, Class III/IV non-scientific amendment, Class I device or private-label/special authorisation transaction with a different fee category. An office-only update is not a manufacturing-process/site change.

Change-specific government fees

Amendment - Class IV significant changes not related to manufacturing