# Canada Medical Device & Drug Decisions (Health Canada) (`loonieledger/canada-health-product-decisions`) Actor

Health Canada Regulatory Decision Summaries: new and amended medical device licence decisions (updated weekly) plus the drug decision, Summary Basis of Decision and Summary Safety Review archive, as clean text. Filter by keyword, company, decision and date.

- **URL**: https://apify.com/loonieledger/canada-health-product-decisions.md
- **Developed by:** [Keegan Carpentier](https://apify.com/loonieledger) (community)
- **Categories:** AI, Developer tools
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $2.50 / 1,000 results

This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events.

Learn more: https://docs.apify.com/actors/running/actors-in-store.md#pay-per-event

## What's an Apify Actor?

An Actor is a serverless cloud program that runs on the Apify platform. It has two run modes.
In Batch mode, an Actor accepts a well-defined JSON input, performs an action which can take anything from a few seconds to a few hours,
and optionally produces a well-defined JSON output, datasets with results, or files in key-value store.
In Standby mode, an Actor provides a web server which can be used as a website, API, or an MCP server.

Apify vocabulary and the platform model are defined once, in the agent quickstart at https://apify.com/agents.md.

## How to integrate an Actor?

If asked about integration, you help developers integrate Actors into their projects.
You adapt to their stack and deliver integrations that are safe, well-documented, and production-ready.

Do not guess an integration path. Every one of them is in the agent quickstart at https://apify.com/agents.md: the Apify MCP server, Agent Skills with the Apify CLI, the JavaScript and Python clients, the REST API, and the account-free path for an agent with no human to sign in. It also carries the rule on stating cost before the first paid run.

For examples already wired to this Actor's own input schema, see the [API](#api) section below.

Each client library has reference documentation the quickstart does not restate: [JavaScript/TypeScript](https://docs.apify.com/api/client/js/docs.md) (`npm install apify-client`) and [Python](https://docs.apify.com/api/client/python/docs.md) (`pip install apify-client`).

# README

## 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

```json
{ "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):

```json
{
  "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`.

# Actor input Schema

## `reportTypes` (type: `array`):

RDS = Regulatory Decision Summaries (current, updated regularly). SBD and SSR = Summary Basis of Decision and Summary Safety Reviews (the API archive currently ends in 2023).

## `language` (type: `string`):

Language of the report text.

## `keywords` (type: `array`):

Keep reports whose title, product, ingredient, manufacturer, therapeutic area, safety issue, purpose or summary contains ANY of these words (case-insensitive).

## `manufacturers` (type: `array`):

Manufacturer name contains any of these (e.g. Medtronic, Pfizer).

## `decisions` (type: `array`):

Decision contains any of these, e.g. Approved, Authorized, Rejected, Cancelled, Withdrawn. Leave empty for all.

## `productKind` (type: `string`):

About 85% of Regulatory Decision Summaries are for medical devices.

## `decidedWithinDays` (type: `integer`):

Only reports whose decision / authorization / review date is within this many days. 0 = no limit. Ignored if 'Decided on or after' is set.

## `decidedSince` (type: `string`):

Only reports dated on or after this date.

## `includeFullText` (type: `boolean`):

Adds a 'fullText' object with the long scientific sections (quality, non-clinical, clinical, benefit/risk …) as plain text.

## `maxTextChars` (type: `integer`):

Long text fields are cut at this length (on a word boundary, ending with …).

## `onlyNew` (type: `boolean`):

Remembers returned reports in the named key-value store 'canada-hp-decisions-state'; next runs return only new reports or reports whose modified date changed.

## `maxItems` (type: `integer`):

Stop after this many reports (newest first). Controls cost.

## Actor input object example

```json
{
  "reportTypes": [
    "RDS",
    "SBD",
    "SSR"
  ],
  "language": "en",
  "keywords": [
    "insulin",
    "glucose"
  ],
  "productKind": "all",
  "decidedWithinDays": 0,
  "includeFullText": false,
  "maxTextChars": 4000,
  "onlyNew": false,
  "maxItems": 200
}
```

# Actor output Schema

## `results` (type: `string`):

Health Canada decision summaries written to the default dataset

# API

You can run this Actor programmatically using our API. Below are code examples in JavaScript, Python, and CLI, as well as the OpenAPI specification and MCP server setup.

## JavaScript example

```javascript
import { ApifyClient } from 'apify-client';

// Initialize the ApifyClient with your Apify API token
// Replace the '<YOUR_API_TOKEN>' with your token
const client = new ApifyClient({
    token: '<YOUR_API_TOKEN>',
});

// Prepare Actor input
const input = {
    "keywords": [
        "insulin",
        "glucose"
    ]
};

// Run the Actor and wait for it to finish
const run = await client.actor("loonieledger/canada-health-product-decisions").call(input);

// Fetch and print Actor results from the run's dataset (if any)
console.log('Results from dataset');
console.log(`💾 Check your data here: https://console.apify.com/storage/datasets/${run.defaultDatasetId}`);
const { items } = await client.dataset(run.defaultDatasetId).listItems();
items.forEach((item) => {
    console.dir(item);
});

// 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/js/docs

```

## Python example

```python
from apify_client import ApifyClient

# Initialize the ApifyClient with your Apify API token
# Replace '<YOUR_API_TOKEN>' with your token.
client = ApifyClient("<YOUR_API_TOKEN>")

# Prepare the Actor input
run_input = { "keywords": [
        "insulin",
        "glucose",
    ] }

# Run the Actor and wait for it to finish
run = client.actor("loonieledger/canada-health-product-decisions").call(run_input=run_input)

# Fetch and print Actor results from the run's dataset (if there are any)
print(f"💾 Check your data here: https://console.apify.com/storage/datasets/{run.default_dataset_id}")
for item in client.dataset(run.default_dataset_id).iterate_items():
    print(item)

# 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/python/docs/quick-start

```

## CLI example

```bash
echo '{
  "keywords": [
    "insulin",
    "glucose"
  ]
}' |
apify call loonieledger/canada-health-product-decisions --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,loonieledger/canada-health-product-decisions"
        }
    }
}
```

The hosted server signs you in with OAuth on first connect, so no API token belongs in this config. Clients without OAuth support can send an `Authorization: Bearer <APIFY_API_TOKEN>` header instead, using a token from API & Integrations in Apify Console (https://console.apify.com/settings/integrations).

## OpenAPI specification

Download the OpenAPI definition: https://api.apify.com/v2/actors/llL0Qavfd1CH3u0Lt/builds/irU1BiK8AzdnY0nta/openapi.json
