regaffairs_check_drug_or_device_approval
shallowcom.regaffairsai/regaffairs · Verify this server
Checks whether a medicine is authorised in a market, with its approval details and shortage status, or a medical device's classification, registration, approval or notified body. Medicines: the FDA Orange Book (approved drugs, therapeutic equivalence, patents and exclusivity), EMA authorised medicines, EMA orphan designations, the EMA, FDA and MHRA shortage lists, the Health Canada Drug Product Database (DIN) and Notice of Compliance database. Devices: the FDA device classification database (product codes, device class, regulation number), FDA De Novo decisions and PMA approvals, FDA MAUDE adverse event reports, MHRA guidance on registering devices for the GB market, EU NANDO notified bodies under the MDR and IVDR, the CDSCO approved device lists (India) and the Italian national medical devices database. Not intended for GMP or ICH guidance (`regaffairs_find_pharma_gmp_and_ich_guidance` covers that), for MDR or IVDR legal requirements, or for clinical trials.
1 trials · measured today
regaffairs_check_drug_or_device_approval scores 100.0/100 on Vouch's measured behaviour index, from 1 real invocation trials against com.regaffairsai/regaffairs, measured 20 Oct 2026 under methodology v0.2.0. Every measured component scored 100.
Component breakdown
| Component | Weight | Value |
|---|---|---|
| Reliability | 35% | not applicable |
| Schema integrity | 25% | 100.0 |
| Failure behaviour | 15% | not applicable |
| Latency | 15% | not applicable |
| Concurrency | 10% | not applicable |
Tool details
- Transport
- remote
- Credential class
- gated
- Input schema
- not declared
- Output schema
- not declared
- Side-effect classification
- unclassified
Score history
| Day | Score | Tier | Methodology |
|---|---|---|---|
| 2026-10-20 | 100.0 | shallow | v0.2.0 |
Probe evidence
| Probe | Outcomes |
|---|---|
| schema_integrity | pass: 1 |
Raw request/response logs are not archived yet — the outcome counts above are drawn directly from every recorded trial.
Embed this score
Available for every tool, scored or not — not a verification perk. Always links back to this page.
[](https://vouch.tools/tools/5a91b598-2c3e-4a82-bf0f-156027102af3)