Introducing ORSD: A Free, Open Regulatory Signal Dataset

Regulatory Data Should Be Open

Regulatory filings are public records. When a company receives FDA 510(k) clearance, when a notified body issues an IVDR certificate, when ANVISA registers a new medical device — these are all government publications, accessible to anyone. In principle, this means every MedTech company, investor, and researcher has equal access to the same regulatory intelligence.

In practice, the data is scattered across dozens of agency websites, each with its own format, update schedule, and access method. Some agencies provide APIs, others require screen scraping, and many publish data in PDFs that need manual extraction. The cost of collecting, normalising, and maintaining this data at scale is prohibitive for most organisations — which is why regulatory intelligence has traditionally been the domain of expensive subscription services.

We believe this should change. That is why we are launching the Open Regulatory Signal Dataset (ORSD) — a public, open-licensed, machine-readable dataset of regulatory signals from every major market worldwide.

What Is in ORSD?

ORSD aggregates regulatory signals from three categories of public data sources:

Regulatory Clearances & Certifications

Every medical device clearance, approval, and certification from major global regulators, including FDA 510(k) and PMA databases, EUDAMED (MDR and IVDR certificates), Health Canada MDALL, ANVISA (Brazil), NMPA (China), PMDA (Japan), TGA (Australia), MFDS (South Korea), CDSCO (India), and WHO Prequalification. Each record includes device classification, product code, applicant information, and decision date.

Patent Filings

Patent grants and published applications from the USPTO, EPO, WIPO PCT, JPO, KIPO, and CNIPA — linked to medical device companies and technologies. Patent data provides early visibility into research direction and competitive positioning years before regulatory filings appear.

Clinical Trials

Trial registrations from ClinicalTrials.gov, EU CTIS, and international registries, with sponsor information, device/procedure classifications, enrollment numbers, and study status. Clinical trial activity is a leading indicator of future regulatory submissions.

Why Open Data?

Open-sourcing regulatory data creates value that proprietary databases cannot match:

Getting Started

ORSD is live and accessible now. No API key is required for basic read access — just send a request:

# Check dataset stats
curl https://orsd.contextual-intelligence.org/v1/stats

# Python
import requests
stats = requests.get('https://orsd.contextual-intelligence.org/v1/stats').json()
print(f"{stats['stats']['coverage']['data_sources']} data sources across {len(stats['stats']['coverage']['countries'])} jurisdictions")

# JavaScript / Node.js
const stats = await fetch('https://orsd.contextual-intelligence.org/v1/stats').then(r => r.json())
console.log(`${stats.stats.coverage.data_sources} data sources`)

Full API documentation is available on our website. The dataset is updated continuously as agencies publish new data.

ORSD and the Contextual Intelligence Platform

ORSD is the data layer. The Contextual Intelligence Platform is what you build on top of it. While ORSD provides raw regulatory signals, the platform adds:

• → Semantic knowledge graphs that correlate regulatory filings with patents, clinical trials, grants, and market data — revealing strategic context that raw signals cannot show
• → Automated alerts via email, Slack, and webhook — know when a competitor files, receives clearance, or enters a new market
• → Custom dashboards and reports tailored to your competitive set, product categories, and geographies of interest
• → API access with higher rate limits and dedicated support for enterprise integrations

Think of ORSD as the foundation — free and open for everyone — and the CI Platform as the premium layer that turns data into decisions.

What Is Coming Next

ORSD is version 0.1 — a foundation, not a finished product. Here is what we are working on next:

• → Historical backfill — FDA 510(k) data going back to 2010, EUDAMED certificates from initial MDR/IVDR implementation, and multi-year patent and clinical trial archives
• → Additional data sources — Saudi Arabia (SFDA), Mexico (COFEPRIS), Singapore (HSA), and more
• → SDK and client libraries — official Python, JavaScript, and Go clients
• → Data downloads — periodic full-dataset exports for offline analysis
• → Community contribution guide — documentation for adding new data sources and improving normalisation

Join Us

ORSD is a bet that open data creates more value than proprietary silos. We are inviting the regulatory intelligence community — MedTech companies, investors, consultants, academics, and regulators — to use the dataset, contribute feedback, and help shape its direction.

The dataset is free. The API is live. Get started today.

Explore the ORSD API →
Get your free API key →
Get your free API key →