Medical Device Regulatory Insights & Podcasts

Latest News

The Access Brief No. 8: FDA Renewals, Medicare Payments & Import Tariff Risks

Issue No. 8 · Week of October 5, 2026 The biggest operational item this week…

Dawa MedicalOctober 5, 2026

Latest News

The Access Brief No. 7: FDA Fees, Device Alerts & Canada Trade Risks

Issue No. 7 · Week of September 28, 2026 Two FDA field actions landed the…

Deryll NewmanSeptember 28, 2026

Latest News

The Access Brief No. 6: VA Market Access, FDA Pathways & Supply Chain Rules

Issue No. 6 · Week of September 21, 2026 The biggest signal for foreign manufacturers…

Deryll NewmanSeptember 21, 2026

Latest News

The Access Brief No. 5: Device Recalls, Cybersecurity & Canada Tariff Relief

Issue No. 5 · Week of September 14, 2026 This week's clearest signal was how…

Dawa MedicalSeptember 14, 2026

Latest News

The Access Brief No. 4: FDA Recalls, Supply Chain Risks & Import Updates

Issue No. 4 · Week of September 7, 2026 This week was less about any…

Dawa MedicalSeptember 7, 2026

Latest News

The Access Brief No. 3: Device Recalls, Supplier Traceability & Canada Tariffs

Issue No. 3 · Week of August 31, 2026 Health Canada had a busy week…

Dawa MedicalAugust 31, 2026

Latest News

The Access Brief No. 2: U.S.-Canada Tariffs & FDA Leadership Changes

Issue No. 2 · Week of August 24, 2026 This week brought real movement on…

Dawa MedicalAugust 24, 2026

Initial Importer News

Navigating FDA Requirements for Importing Medical Devices

The FDA’s “Importing Medical Devices” guidance explains what manufacturers and distributors must do before medical…

Dawa MedicalApril 29, 2026

FDA News

FDA ImportShield Centralizes Port Oversight and Boosts Efficiency

The FDA’s ImportShield Program (FISP) was launched in August 2025 to modernize how the agency…

Dawa MedicalApril 29, 2026

FDA News

FDA FY 2026 Legislative Agenda: What Device and Drug Makers Should Watch

The U.S. FDA’s fiscal‑year 2026 legislative request, released in July 2025, outlines a wish list…

Dawa MedicalApril 29, 2026

FDA News

FDA Aligns U.S. Device Quality Standards with ISO 13485: Implications of the QMSR Rule

The FDA’s Quality Management System Regulation (QMSR) took effect on February 2 2026, replacing the…

Dawa MedicalApril 28, 2026

Podcast

Import IQ: Episode 5 Understanding the UDI with Hussam Mostafa

In this episode of Import IQ, we explore the Unique Device Identification (UDI) system and…

Dawa MedicalApril 10, 2025

Podcast

Import IQ: Episode 4 Understanding what is a value analysis committee

Welcome to Episode 4-Understanding what is a value analysis committee, where we dive into the…

Dawa MedicalMarch 6, 2025

Podcast

How to Thrive in the U.S. Medical Device Market With Stéphan Toupin

Stéphan Toupin, a standout in the medical sales industry, unveils his journey from academia to…

Dawa MedicalOctober 10, 2024