Topic

Device vigilance

Medical device vigilance runs alongside medicinal-product pharmacovigilance and increasingly intersects with combination products. Browse briefings on field safety notices, post-market surveillance expectations, and regulator device hubs that device vigilance leads should track.

2 matching updates · Sorted by impact priority

publicTherapeutic Goods Administration (TGA) · Australia · Updated Jun 11, 2026

TGA Approval 2026: Six Monthly Report Form for Unapproved Therapeutic Goods

Urgency: Low

Sponsors and MAHs must replace the 2021 form with the new 2026 approved form for all six-monthly reports on unapproved therapeutic goods supplied under SAS and CTA schemes.

Country ComplianceICSRRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, QPPV

verifiedRegulatory action: Form

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publicFDA · USA · Updated Jun 5, 2026

FDA Intent to Exempt Certain Unclassified Medical Devices from 510(k) Requirements

Urgency: Low

Identify which unclassified medical devices are affected by the exemption; update regulatory submissions and post-market surveillance plans accordingly; ensure compliance with general controls and post-market surveillance obligations.

Country ComplianceRegulatory Intelligence Lead

SOP Impact1 SOPs

ConfidenceLow

Relevant for: Regulatory Intelligence Lead, QPPV

verifiedRegulatory action: Guideline

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