Health Canada Reports Longer Review Times for Class III and IV Medical Devices: Updated Performance Metrics Through July 2026 

Health Canada has published updated performance data for medical device licensing, covering average market authorization times, screening performance, review backlogs, and application volumes, in its Medical Devices Performance Metrics report. The figures cover the period from August 2025 to July 2026, with some tables specific to July 2026, and the page was last updated on 31 August 2026. The data is relevant to any manufacturer or importer planning a Class II, III, or IV medical device or IVD submission in Canada, since it shows how long licensing decisions are currently taking against Health Canada’s own service targets. 

Note on sourcing: this data is currently published on the GCcollab wiki, a Government of Canada collaboration platform, rather than on canada.ca. MedEnvoy recommends cross-checking figures against Health Canada’s official performance reporting before relying on them for submission planning. 

Overview 

Under the Medical Devices Regulations, Health Canada reviews licence applications against published service targets and reports on its performance periodically. Average market authorization time is measured from application receipt to licence issuance, and includes both Health Canada’s review activities and the time manufacturers take to respond to request for additional information. Separate targets apply to regulatory screening (from 7 calendar days for minor change applications to a 15– calendar days for Class II/III/IV applications), technical/scientific review (from 60 calendar days to 75 days depending on the application class and type), standard investigational testing authorizations (30 calendar days), and the Special Access Program (a 3-working days cycle for individual patient requests). 

The current release reflects application activity through July 2026 and shows a mixed performance picture: routine application types are being processed quickly, while Class III and IV new applications, significant-change amendments, and combination products are taking longer than in prior periods, and Class IV screening is now running slightly outside its 15-day target. 

Key Points 

• Class II and minor-change applications remain fast. Class II new applications average 27.1 days overall (21 days with Health Canada, 6.1 with the manufacturer); Class II amendments average 7.5 days; minor changes average just 3.5 days. 

• Class III and IV new applications are taking significantly longer. Class III new applications average 164 days overall (110.9 days with Health Canada, 53.1 with the manufacturer); Class IV new applications average 177.6 days (119.9 with Health Canada, 57.7 with the manufacturer). 

• Combination products (drug + device) show the longest average timeline by far. Combination products average 755 days overall for the August 2025–July 2026 period (432 days with Health Canada, 323 with the manufacturer), reflecting the added time needed for other Health Canada directorates, such as the Pharmaceutical Drugs Directorate, to complete their portion of the review. 

• Class IV screening is exceeding its 15-day target. Average screening time is 11 days for Class III applications (within target) but 16 days for Class IV applications (over the 15-day target). 

• A modest backlog exists across all classes. As a point-in-time snapshot, Health Canada reports 7 Class II, 10 Class III, and 2 Class IV applications in review backlog, meaning a first or subsequent decision deadline was missed. 

• Investigational testing and Special Access performance remain strong. Investigational testing authorizations are meeting the 30-day target 93% of the time; Special Access Program requests are meeting the 3-working day target 96% of the time. 

• What does not change. These are performance-reporting metrics, not changes to the Medical Devices Regulations, application requirements, or fee structure. No new submission format, licence category, or regulatory obligation is introduced. 

Expert Insights and Broader Implications 

The gap between routine and complex application types is the headline here. A minor change or Class II amendment still clears in days, but a Class III or IV new licence application now averages five to six months, and a substantial share of that time — roughly a third to just under half — sits with the manufacturer responding to information requests. For companies planning a Canadian launch, the practical lever is application completeness: incomplete submissions restart review clocks and directly extend timelines that are already lengthening. 

Combination product sponsors should treat the 755-day average as a planning input, not a target to challenge. Because combination product review draws in other Health Canada directorates beyond the Medical Devices Directorate, the timeline is structurally different from a standard device review, and sponsors should build cross-directorate coordination into their submission strategy from the outset rather than treating it as a device-only file. 

The Class IV screening figure — 16 days against a 15-day target — is a small miss, but it is worth watching over subsequent reporting periods to see whether it reflects a temporary volume spike or a sustained trend. Manufacturers with Class IV applications in the pipeline should build a modest buffer into their internal timelines rather than assuming the published target will hold. This data is specific to Health Canada and does not have a direct equivalent in the EU, UK, or US reporting structures, but it is a useful benchmark for manufacturers sequencing a Canadian licence application alongside submissions in other markets under a coordinated global launch plan. 

What This Means for Manufacturers 

• Build realistic timelines for Class III and IV submissions. Plan for average review times of roughly five to six months for new applications, and confirm whether your submission falls into a significant-change or manufacturing-change amendment category, since these carry different average timelines. 

• Prioritize submission completeness. Since manufacturer response time makes up a substantial share of total review time, invest in a thorough pre-submission review to reduce the number of information request cycles. 

• Plan combination product timelines separately. If your product involves a drug, biologic, or radiopharmaceutical component, budget for a materially longer review and coordinate early with the relevant Health Canada directorates. 

• Monitor backlog risk for your application class. Applications already in backlog have missed a decision target; if your submission is approaching a decision date, confirm status proactively rather than assuming the published target will be met. 

• Watch subsequent reporting periods for the Class IV screening trend. Confirm whether the 16-day average against the 15-day target is repeated in future updates before treating it as a stable data point. 

• Verify the source data before relying on it for planning. Cross-check figures against Health Canada’s official canada.ca performance reporting, since this release is currently hosted on a Government of Canada collaboration wiki. 

Learn More / How MedEnvoy Can Support 

MedEnvoy tracks Health Canada’s medical device performance reporting as part of its regulatory intelligence service, because review timelines directly affect launch planning, licensing strategy, and post-market obligations for manufacturers targeting the Canadian market. 

MedEnvoy can support Canadian market authorization strategy, submission completeness review to reduce information request cycles, combination product coordination planning, and ongoing monitoring of Health Canada performance reporting on your behalf. To discuss how these timelines affect your Canadian submission plans, contact us here: Talk To An Expert