Canada Medical Device & Drug Decisions – Health Canada Regulatory Decision Summaries

Export Health Canada's Regulatory Decision Summaries (RDS) – every new and amended medical device licence decision, plus drug decisions – together with the Summary Basis of Decision (SBD) and Summary Safety Review (SSR) archive, as clean JSON, CSV or Excel. HTML is converted to plain text. Filter by keyword, manufacturer, decision (approved, rejected, cancelled, withdrawn), drugs vs devices and date, or schedule a "new decisions only" monitor.

• ✅ Official Health Canada Summary Reports API (about 9,500 reports). No scraping, no login, no API key
• ✅ Medical device decisions are current (about 90 new decisions a month)
• ✅ Negative decisions too: rejections, cancellations and withdrawals are hard to find anywhere else
• ✅ Optional full scientific text for SBDs (quality, non-clinical, clinical, benefit/risk) and SSRs
• ✅ onlyNew monitoring mode; English or French; pay only for the results you get

Who it's for

• Medtech manufacturers, distributors and regulatory consultants watching competitors' Canadian device licences
• Pharma regulatory-affairs teams researching how Health Canada decided on comparable products
• Market-access, investors and analysts, and AI/RAG pipelines that need clean regulatory text

Input

Field	What it does	Default
reportTypes	RDS, SBD, SSR	all three
language	en or fr	en
keywords	Title, product, ingredient, manufacturer, therapeutic area, safety issue, purpose or summary contains any of these	["insulin","glucose"] (prefill)
manufacturers	Manufacturer contains any of these	all
decisions	Decision contains any of these, e.g. Approved, Rejected, Cancel, Withdrawn	all
productKind	all, drugs or devices	all
decidedWithinDays / decidedSince	Window on the decision / authorization / review date	no limit
includeFullText / maxTextChars	Long SBD/SSR sections as plain text; cut at N characters	off / 4000
onlyNew	Only reports not returned before	off
maxItems	Hard cap on results (and on cost), newest first	200

Example: every new device decision for a list of competitors, weekly

{ "productKind": "devices", "manufacturers": ["Medtronic", "Abbott", "Dexcom"], "decidedWithinDays": 14, "onlyNew": true }

Output

One row per report. A real record from a live test (29 Sep 2026):

{
  "reportType": "Regulatory Decision Summary",
  "reportTypeCode": "RDS",
  "reportId": "RDS17371",
  "title": "Regulatory Decision Summary – XPER TECHNOLOGY A1 PRO BLOOD GLUCOSE MONITORING SYSTEM",
  "productName": "XPER TECHNOLOGY A1 PRO BLOOD GLUCOSE MONITORING SYSTEM",
  "medicinalIngredients": null,
  "manufacturer": "TAIDOC TECHNOLOGY CORPORATION",
  "isMedicalDevice": true,
  "therapeuticArea": null,
  "submissionType": "New device licence application",
  "controlNumber": "406378",
  "applicationNumber": null,
  "applicationType": null,
  "deviceClass": null,
  "licenceNumber": null,
  "decision": "Approved",
  "decisionDetails": null,
  "decisionDate": "2026-08-17",
  "dateFiled": null,
  "dins": [],
  "prescriptionStatus": null,
  "purpose": null,
  "reasonForDecision": null,
  "summary": null,
  "modifiedDate": null,
  "recordKey": "RDS17371-406378",
  "url": "https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS17371",
  "language": "en",
  "source": "Health Canada – Summary Reports API (Drug and Health Product Register)",
  "licence": "Open Government Licence – Canada",
  "attribution": "Contains information licensed under the Open Government Licence – Canada.",
  "scrapedAt": "2026-09-29T22:51:50+00:00"
}

Drug RDS rows also carry therapeuticArea, purpose, reasonForDecision, dins and prescriptionStatus; SBD rows whatWasApproved and whyApproved; SSR rows safetyIssue, keyMessages, findings and conclusions. More real rows are in sample_output.json.

Pricing

Pay per result. You're charged once per report written to the dataset.

Data source, licence and privacy

• Source: Health Canada Summary Reports API (Drug and Health Product Register) – https://health-products.canada.ca/api/documentation/summary-report-documentation-en.html (dataset: https://open.canada.ca/data/en/dataset/9e168ff0-ece9-44de-bbec-68878454cbc1). Each row links to the official page on dhpp.hpfb-dgpsa.ca.
• Licence: Open Government Licence – Canada. Every row carries the required attribution statement.
• Company and product data only. Contact fields in the source are Health Canada bureaux. No personal information.
• Unofficial tool, not affiliated with or endorsed by Health Canada.

Limits and notes

• Coverage: in the API, medical device RDS are current, but drug RDS, SBD and SSR reports currently end in March 2023. Use the companion Canada Drug Approvals (NOC) Actor for current drug approvals.
• Device RDS rows are short in the source (product, manufacturer, submission type, decision and date).
• A handful of report IDs are shared by two products in the source; each row has a unique recordKey.