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Canada medical device regulations

Official sources linked

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

13 documents6 categories100% linked to official sourcesauthority Health Canada7 readable HTML
CodeRegulationCategoryEffectiveProvenance
HC Guidance — MDL Applications
Guidance on managing applications for medical device licences
Current Health Canada guidance on how Class II-IV medical device licence applications are managed end to end, as one merged document from its 7-page family: filing (fees, submission channels, target performance standards), administrative/regulatory/technical screening, review (clarification requests, additional-information letters, pause-the-clock, refusal), refiling within and after 6 months, and the reconsideration process for refused applications, plus process-map appendices. Foreword document control: version 5, published 21 November 2025, effective 2 February 2026, replacing the 1 April 2020 edition. Ingested from the exact official HTML with a foreword preamble and continuous sec-1..sec-32 section anchors across part-1..part-7 (one part per page).
RegistrationFebruary 2, 2026Official
SOR/98-282 Schedule 1 Part 2
In Vitro Diagnostic Device Classification
Section view of Schedule 1 Part 2 IVD classification rules. Official Schedule 2 is “Implants”; the previous Schedule 2 IVD label was corrected against the Justice Laws consolidated text.
ClassificationJuly 1, 1998Official
SOR/98-282 ss. 21–23
Medical Device Labeling Requirements
Section view of SOR/98-282 labelling requirements including bilingual consumer-device labelling, manufacturer identification, and directions for use.
LabelingJuly 1, 1998Official
SOR/98-282 ss. 44–51.1
Medical Device Establishment Licence (MDEL)
Section view of SOR/98-282 Part 1 establishment-licence provisions (ss. 44 to 51.1). MDEL requirements for manufacturers (Class I) and importers/distributors (all classes).
RegistrationJuly 1, 1998Official
SOR/98-282 ss. 26–43.6
Medical Device Licence (MDL)
Section view of SOR/98-282 Part 1 Class II–IV medical device licence provisions. The previous “Part 2” label was incorrect: official Part 2 is custom-made and special-access devices.
RegistrationJuly 1, 1998Official
SOR/98-282 ss. 59–62
Mandatory Problem Reporting (MPR)
Section view of SOR/98-282 incident-reporting and hospital-information provisions (ss. 59 to 62). Later shortage sections (62.21+) are not part of this view.
VigilanceJuly 1, 1998Official
SOR/98-282
Medical Devices Regulations
Primary regulation governing medical devices in Canada. Establishes classification (Class I-IV), licensing requirements, establishment licensing (MDEL), and post-market obligations. Official consolidated expression from Justice Laws; current to 17 June 2026.
RegistrationJuly 1, 1998Official
R.S.C., 1985, c. F-27
Food and Drugs Act
Parent statute of the Canadian medical-device regime: the Food and Drugs Act defines "device" (s. 2) and establishes the offences, inspection, and regulation-making powers (s. 30) under which the Medical Devices Regulations (SOR/98-282) are made. Part I (Foods, Drugs, Cosmetics and Devices) carries the sale and advertising prohibitions, including prohibited advertising (s. 3) and prohibited sales of devices (s. 8); Part II is Administration and Enforcement. Official consolidated expression from Justice Laws in both official languages, current to 31 March 2025 (last amended 27 March 2025); 107 sections across Parts I and II plus Schedules A to H (Schedule A.1 inserted 2019).
General—Official
HC Guidance — Devices
Guidance for the Labelling of Medical Devices, not including in vitro diagnostic devices
Complete Health Canada labelling guidance for medical devices other than IVDs, walked regulation-by-regulation through Medical Devices Regulations sections 21-24 (label contents, outer package, bilingual s. 23 requirements, and electronic labelling conditions) plus the two appendices for soft/decorative contact lenses and menstrual tampons published on the same page. Foreword document control: adopted 12 June 2004, version date 15 June 2015 (replaces the 2014-06-12 version). The URL slug ("including-vitro-diagnostic-devices-appendices") is stale; the current page title governs. Ingested from the exact official HTML with a foreword preamble (document control block incl. change log) and sec-1..sec-5 section anchors.
Labeling—Official
HC Guidance — IVD
Guidance for the Labelling of In Vitro Diagnostic Devices
Complete Health Canada labelling guidance for in vitro diagnostic devices: label and package-insert requirements walked element-by-element through MDR section 21(1)(a)-(j) (name, manufacturer, identifier, directions for use, performance characteristics, storage), outer-container requirements, sections 22-24 including bilingual accommodation under section 23, special considerations for blood glucose monitoring systems, and labelling for IVDDs containing explosive or corrosive materials. Foreword document control: date 22 April 2016, replacing the 1998/06/16 draft guidance. Ingested from the exact official HTML with a foreword preamble and sec-1..sec-7 section anchors.
Labeling—Official
HC Guidance — New/Amended Licences
Guidance on how to complete the application for a new or amended medical device licence
Health Canada guidance on when a new medical device licence is required versus an amendment and how to complete each application type, as one merged document from its 6-page family: overview and policy objective, definitions (licence application types, regulatory activities and transactions), implementation guidance for new licences and amendments (including Dossier ID requests), references, and the Bisphenol A and Di(2-Ethylhexyl) Phthalate chemical-identity appendices. All six pages carry date modified 24 April 2026. Ingested from the exact official HTML with continuous sec-1..sec-12 section anchors across part-1..part-6 (one part per page).
Registration—Official
HC Guidance — Significant Change
Guidance on how to interpret "significant change" of a medical device
Current Health Canada guidance interpreting "significant change" under Medical Devices Regulations s. 32, as one merged document from its 5-page family: purpose and policy statements, general principles (risk assessment, the four-corner principle, design verification and validation), types of changes (design, software, sterilization and sterile barrier packaging, materials, labelling, manufacturing processes and facilities, diagnostic ultrasound), and the process for significant changes (amendment applications), minor changes, and non-significant changes including recalls. Foreword document control: published 31 March 2026, all five pages carrying the same date; the guidance also exists as a consolidated official PDF, while these HTML pages stay the ingest source for citeable anchors. Ingested from the exact official HTML with a foreword preamble and continuous sec-1..sec-27 section anchors across part-1..part-5 (one part per page).
Registration—Official
MDSAP
Medical Device Single Audit Program
Health Canada MDSAP transition page, not a Justice Laws instrument. Left as discovery metadata; the program description is not ingested as regulation source text.
GMP/QMS—Official
Exports carry source + retrieval date

Changes after registration in Canada

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

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

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

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Change requiring licence amendment

Fact-level verified

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

Fact-level verified

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.

Guidance for interpreting significant changes to medical devices — 2026

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

Fact-level verified

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 submission portal

Fact-level verified

MDL applications and amendments are filed through the Regulatory Enrolment Process (REP) at health-products.canada.ca/rep-pir: company enrolment via the Company (CO) template yields a company ID; a dossier ID is obtained via a request form; and a regulatory transaction template is required with each transaction filed to Health Canada, with a device details file required for new and catalogue-affecting amendment applications.

Conditions
  • Applies to MDL new applications and amendments (including private label).

REP listing on the forms page dated 2026-04-27; Medical Device Licence Application Fee Form listed 2025-03-21.

  • Supporting documents

REP product amendment files

Fact-level verified

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.

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

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

Fact-level verified

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.

2026 medical-device licence application fees

Conditions for this question

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

Fact-level verified

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

Fact-level verified

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

Fact-level verified

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

Fact-level verified

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

Fact-level verified

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.

FRM0539 complete MCE/CFS form

Conditions for this question

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

Conditions for this question

  • Only 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

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

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

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

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

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

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Change requiring licence amendment

Fact-level verified

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

Fact-level verified

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.

Guidance for interpreting significant changes to medical devices — 2026

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

Fact-level verified

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.

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

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

Fact-level verified

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 submission portal

Fact-level verified

MDL applications and amendments are filed through the Regulatory Enrolment Process (REP) at health-products.canada.ca/rep-pir: company enrolment via the Company (CO) template yields a company ID; a dossier ID is obtained via a request form; and a regulatory transaction template is required with each transaction filed to Health Canada, with a device details file required for new and catalogue-affecting amendment applications.

Conditions
  • Applies to MDL new applications and amendments (including private label).

REP listing on the forms page dated 2026-04-27; Medical Device Licence Application Fee Form listed 2025-03-21.

  • Supporting documents

REP product amendment files

Fact-level verified

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.

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

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

Fact-level verified

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

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

Fact-level verified

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.

2026 medical-device licence application fees

Conditions for this question

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

Fact-level verified

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

Fact-level verified

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

Fact-level verified

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

Fact-level verified

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

Fact-level verified

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.

FRM0539 complete MCE/CFS form

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

Fact-level verified

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

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

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

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

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

What changes when the manufacturer's office address changes?

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

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Change requiring licence amendment

Fact-level verified

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

Fact-level verified

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.

Guidance for interpreting significant changes to medical devices — 2026

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

Fact-level verified

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.

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

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

Fact-level verified

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

Fact-level verified

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.

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

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

Fact-level verified

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

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 submission portal

Fact-level verified

MDL applications and amendments are filed through the Regulatory Enrolment Process (REP) at health-products.canada.ca/rep-pir: company enrolment via the Company (CO) template yields a company ID; a dossier ID is obtained via a request form; and a regulatory transaction template is required with each transaction filed to Health Canada, with a device details file required for new and catalogue-affecting amendment applications.

Conditions
  • Applies to MDL new applications and amendments (including private label).

REP listing on the forms page dated 2026-04-27; Medical Device Licence Application Fee Form listed 2025-03-21.

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

Fact-level verified

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.

2026 medical-device licence application fees

Conditions for this question

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

Fact-level verified

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

Fact-level verified

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

Fact-level verified

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

Fact-level verified

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

Fact-level verified

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.

FRM0539 complete MCE/CFS form

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

Fact-level verified

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

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

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

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

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

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

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

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Change requiring licence amendment

Fact-level verified

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

Fact-level verified

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.

Guidance for interpreting significant changes to medical devices — 2026

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

Fact-level verified

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.

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

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

Fact-level verified

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

Fact-level verified

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 submission portal

Fact-level verified

MDL applications and amendments are filed through the Regulatory Enrolment Process (REP) at health-products.canada.ca/rep-pir: company enrolment via the Company (CO) template yields a company ID; a dossier ID is obtained via a request form; and a regulatory transaction template is required with each transaction filed to Health Canada, with a device details file required for new and catalogue-affecting amendment applications.

Conditions
  • Applies to MDL new applications and amendments (including private label).

REP listing on the forms page dated 2026-04-27; Medical Device Licence Application Fee Form listed 2025-03-21.

  • Supporting documents

REP product amendment files

Fact-level verified

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.

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

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

Fact-level verified

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

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

Fact-level verified

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.

2026 medical-device licence application fees

Conditions for this question

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

Fact-level verified

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

Fact-level verified

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

Fact-level verified

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

Fact-level verified

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.

FRM0539 complete MCE/CFS form

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

Fact-level verified

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

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

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

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

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

Can several changes be filed together?

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

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Change requiring licence amendment

Fact-level verified

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

Fact-level verified

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.

Guidance for interpreting significant changes to medical devices — 2026

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

Fact-level verified

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.

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

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

Fact-level verified

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

Fact-level verified

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

Fact-level verified

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.

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

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

Fact-level verified

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

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 submission portal

Fact-level verified

MDL applications and amendments are filed through the Regulatory Enrolment Process (REP) at health-products.canada.ca/rep-pir: company enrolment via the Company (CO) template yields a company ID; a dossier ID is obtained via a request form; and a regulatory transaction template is required with each transaction filed to Health Canada, with a device details file required for new and catalogue-affecting amendment applications.

Conditions
  • Applies to MDL new applications and amendments (including private label).

REP listing on the forms page dated 2026-04-27; Medical Device Licence Application Fee Form listed 2025-03-21.

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

Fact-level verified

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.

2026 medical-device licence application fees

Conditions for this question

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

Fact-level verified

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

Fact-level verified

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

Fact-level verified

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

Fact-level verified

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

Fact-level verified

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.

FRM0539 complete MCE/CFS form

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

Fact-level verified

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

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

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

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

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.
Change control →Official forms & portals →Dossier requirements →
Regulation codes

What these codes are

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

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Tracked from official Health Canada publications · row IDs are stable — cite as regulations:canada:fda-act