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Regulatory Alerts

Track medical device regulatory alerts across FDA, EU MDR, MFDS, PMDA, NMPA, and other agencies. Monitor policy changes that affect certification, labeling, and market access.

Stay updated on regulatory changes affecting medical devices32

FDACriticalNew Regulation

FDA QMSR (Quality Management System Regulation) Effective Date

The new QMSR replacing 21 CFR 820 with ISO 13485:2016 incorporation takes full effect. All manufacturers must comply with the updated quality system requirements.

Affected Markets:USA
Source →
MFDSCriticalDeadlineD-100

MFDS 5-Year Medical Device Re-registration Deadline

Medical devices registered before 2021 must complete 5-year renewal. Failure to re-register by deadline results in automatic license cancellation.

Affected Markets:Korea
Source →
European CommissionCriticalDeadlineD-1015

EU MDR Notified Body Capacity Crisis — Extended Deadlines

Extended transition deadlines for legacy devices: Class III and IIb implantable to Dec 2027, all other classes to Dec 2028. Notified Body capacity remains a bottleneck with only 39 designated NBs.

Affected Markets:EU
European CommissionCriticalNew RegulationD-497

EU AI Act — High-Risk AI Medical Devices Compliance

AI-based medical devices classified as "high-risk" under EU AI Act must comply with transparency, data governance, and human oversight requirements by August 2027.

Affected Markets:EU
Source →
FDACriticalNew RegulationD-193

FDA Cybersecurity Requirements for Medical Devices — Section 524B

Pre-market and post-market cybersecurity requirements become mandatory for all cyber-connected medical devices. Submissions must include a Software Bill of Materials (SBOM), threat modeling, and a cybersecurity management plan. Devices lacking compliance will receive Refuse to Accept (RTA) decisions.

Affected Markets:USA
Source →
European CommissionCriticalDeadlineD-796

EU IVDR Full Application Deadline — Legacy IVD Transition

All legacy in-vitro diagnostic medical devices must complete the transition to EU IVDR (Regulation 2017/746). Class D and Class C IVDs that have not obtained IVDR certification will lose their market authorization. Manufacturers must engage a Notified Body and submit conformity assessment applications well in advance.

Affected Markets:EU
Source →

Featured Regulatory Alerts

FDA QMSR (Quality Management System Regulation) Effective Date

FDA

The new QMSR replacing 21 CFR 820 with ISO 13485:2016 incorporation takes full effect. All manufacturers must comply with the updated quality system requirements.

critical2026-02-02

MFDS 5-Year Medical Device Re-registration Deadline

MFDS

Medical devices registered before 2021 must complete 5-year renewal. Failure to re-register by deadline results in automatic license cancellation.

critical2026-06-30

MDCG 2025-10: Clinical Evaluation Under MDR — Updated Guidance

MDCG

Updated guidance on clinical evaluation requirements under EU MDR, including new expectations for clinical investigation planning and post-market clinical follow-up.

important

NMPA UDI Expansion to Class I Devices

NMPA

China expands Unique Device Identification (UDI) requirements to Class I medical devices. All manufacturers must implement UDI labeling and database registration.

important2026-06-01

EU MDR Notified Body Capacity Crisis — Extended Deadlines

European Commission

Extended transition deadlines for legacy devices: Class III and IIb implantable to Dec 2027, all other classes to Dec 2028. Notified Body capacity remains a bottleneck with only 39 designated NBs.

critical2028-12-31

SFDA Medical Device Registration System Update 2026

SFDA

Saudi FDA launches updated MDMA (Medical Device Marketing Authorization) system with new technical documentation requirements aligned with IMDRF standards.

important2026-03-01

Explore all 32 regulatory alerts →

Frequently Asked Questions

What types of regulatory alerts are tracked?

Alerts cover guidance updates, recall notices, post-market surveillance requirements, labeling changes, and policy shifts from agencies including FDA, EU MDR authorities, MFDS, PMDA, and NMPA.

How often are regulatory alerts updated?

Alerts are collected automatically from official agency feeds and updated as new publications become available. Check the timestamp on each alert for the most recent update.

How should I use alerts alongside certification planning?

Review alerts for your target markets before filing submissions. A recent guidance change could affect your application timeline, required documentation, or post-market obligations.

Monitor regulatory change before it becomes operational risk

Medical device export execution is highly exposed to guidance updates, recall notices, post-market obligations, and policy shifts. This page centralizes regulatory alerts so teams can identify change early instead of reacting after a submission or shipment is blocked.

Use alerts alongside certifications and country guides to understand whether a rule change affects current filings, future launch timing, or partner instructions in market.

What This Page Helps You Do

  • Track agency updates that affect approvals, labeling, and post-market obligations.
  • Review alerts by market before filing or shipping decisions.
  • Connect alert monitoring to certifications and country launch plans.