regaffairs_check_drug_or_device_approval

shallow

com.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.

100.0/100

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

ComponentWeightValue
Reliability35%not applicable
Schema integrity25%100.0
Failure behaviour15%not applicable
Latency15%not applicable
Concurrency10%not applicable

Tool details

Transport
remote
Credential class
gated
Input schema
not declared
Output schema
not declared
Side-effect classification
unclassified

Score history

DayScoreTierMethodology
2026-10-20100.0shallowv0.2.0

Probe evidence

ProbeOutcomes
schema_integritypass: 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.

Vouch score: regaffairs_check_drug_or_device_approval
[![Vouch score](https://vouch.tools/api/tools/5a91b598-2c3e-4a82-bf0f-156027102af3/badge.svg)](https://vouch.tools/tools/5a91b598-2c3e-4a82-bf0f-156027102af3)
regaffairs_check_drug_or_device_approval — Vouch