Regulatory

Guide to Egypt EDA medical device registration in 2026, covering EU MDR-aligned classification, the MeDevice portal, ERH requirements, fees, timelines, and simplification measures.

Register medical devices in Qatar, Kuwait, Bahrain, and Oman, including Kuwait Decree 387/2025, Bahrain NHRA, Oman MOH, Qatar MOPH, and GCC alignment.

Use IMDRF reliance and harmonization trends to streamline global device registration, including the Reliance Playbook, MDSAP, ASEAN submissions, and national reliance pathways.

Build a startup regulatory strategy covering FDA pathway selection, budgets, Q-Subs, eSTAR templates, QMSR readiness, fundraising alignment, and 2026 accelerator programs.

Compare IVD registration requirements across MENA, including Saudi SFDA, UAE EDE, Egypt EDA, Turkey TITCK, Israel AMAR, companion diagnostics, performance evidence, and point-of-care rules.

Compare MENA medical device clinical trial requirements, including Saudi SFDA, UAE, Egypt, Turkey, Israel, Qatar, authorization routes, evidence expectations, and multi-country trial planning.

Plan MENA medical device import, customs, and free zone strategy, including GCC tariffs, Saudi SABER and ZATCA, UAE EDE, Egypt EDA, Turkey TITCK, and duty optimization.

Compare MENA post-market surveillance and vigilance rules for devices, including Saudi SFDA, UAE EDE, Turkey TITCK, Israel IRH, Egypt EDA, reporting timelines, PSURs, and shortage notices.

Medical device registration guide for Morocco, Algeria, and Tunisia, covering AMMPS, ANPP, DPM/ANMPS requirements, timelines, eCTD, serialization, and 2026 updates.

UAE medical device registration guide under EDE, covering classification, fees, LAR requirements, DHA/DOH differences, and the post-MOHAP transition process.

Register medical devices in Chile through ISP, including classification, GICONA submission, fees, timelines, documentation, and the 2026 decree expansion.

Guide to the European Commission MDR and IVDR simplification proposal, including software Rule 11, certificate validity, sandboxes, fees, timelines, and manufacturer impact.

How FTC enforcement is reshaping medtech M&A in 2025-2026, including Edwards/JenaValve, GTCR/Surmodics, HSR changes, and state mini-HSR laws.

Register medical devices in Peru through DIGEMID, covering risk classification, VUCE submission, documentation, holder duties, fees, timelines, and market access strategy.

Manage EU MDR Field Safety Corrective Actions, including FSCA triggers, 2/10/15-day reports, Field Safety Notices, EUDAMED, and FDA recall differences.

Guide to complaint handling for medical devices under FDA QMSR, ISO 13485, and EU MDR, covering intake, reportability, CAPA links, records, and audits.

Six-country ASEAN matrix covering distributor licenses, QMS and warehouse requirements, vigilance setup, and where FDA or NMPA test reports may reduce retesting.

How to classify hand sanitizer, mouthwash, personal lubricants, and data recorders as medical devices or non-devices across FDA, EU MDR, Brazil ANVISA, and Mexico COFEPRIS.

Learn how dual CE Mark and FDA 510(k)/PMA approval expands access across 25+ markets, speeds reliance registrations, and improves market-entry leverage.

Guide to FDA and EU regulation of drug-device combination products, covering OCP jurisdiction, RFDs, 21 CFR Part 4, EU MDR Article 117, CGMPs, and post-market duties.