Regulatory

Complete guide to medical device clinical trial requirements across MENA — Saudi SFDA MDS-REQ-2 clinical trial framework (295 studies evaluated, 157 approved), UAE clinical investigation pathways, Egypt EDA Clinical Trials Law 214/2020 with three authorization pathways, Turkey TITCK Regulation on Clinical Trials, Israel MOH oversight, Qatar Law 6/2025, and practical strategies for multi-country trial management.

Practical guide to medical device import, customs duties, and free zone strategies across MENA — GCC Common Customs Tariff (5% standard rate), Saudi SABER/ZATCA procedures and 2026 tariff code updates, UAE EDE import requirements and free zone advantages (DHCC, DSP), Egypt EDA import approval and customs clearance, Turkey TITCK import controls, and optimization strategies for duty reduction.

Complete guide to post-market surveillance and vigilance requirements for medical devices across MENA — SFDA MDS-REQ11 (2-day/10-day/30-day reporting, change notifications, 90-day renewal), UAE EDE biennial PSUR for high-risk devices, Turkey TITCK 6-month shortage notification, Israel IRH periodic post-marketing reports, and Egypt EDA vigilance obligations.

Complete guide to medical device registration in North Africa — Morocco AMMPS/DMP (120 days, 5-year validity, 2026 local manufacturing pact), Algeria ANPP serialization framework (GS1 2D DataMatrix by 2027), and Tunisia DPM/ANMPS requirements including eCTD mandate from June 2026.

How to register medical devices in the UAE under the Emirates Drug Establishment (EDE) — classification, fees, LAR requirements, DHA vs DOH differences, and the full step-by-step process after the 2026 MOHAP transition.

A complete guide to registering medical devices in Chile through ISP (Instituto de Salud Pública). Covers the four-class risk system, GICONA registration platform, documentation requirements, fees, timelines, and the new March 2026 decree expanding mandatory registration to 39 additional device categories.

A complete guide to the European Commission's December 2025 proposal to simplify MDR and IVDR. Covers the new Rule 11 for software, indefinite certificate validity, regulatory sandboxes, breakthrough and orphan device pathways, fixed conformity timelines, SME fee reductions, and the expected legislative timeline through 2027.

An in-depth analysis of how the Federal Trade Commission is reshaping medtech dealmaking — from blocking the Edwards/JenaValve TAVR deal to the GTCR/Surmodics outcome, HSR filing changes, and the rise of state-level mini-HSR laws.

A complete guide to registering medical devices in Peru through DIGEMID. Covers the four-class risk system under Law 29459, VUCE electronic submission, documentation requirements by class, Peru Registration Holder obligations, fees, timelines, and practical strategies for faster market access.

A complete guide to Field Safety Corrective Actions under EU MDR — when an FSCA is required, reporting timelines (2/10/15 days), how to prepare a Field Safety Notice (FSN), competent authority notification, EUDAMED integration, and how FSCA differs from FDA recalls.

A complete guide to medical device complaint handling — regulatory requirements under FDA 21 CFR 820 (QMSR), ISO 13485, and EU MDR, step-by-step process, MDR reportability decisions, CAPA integration, and documentation best practices.

A reference matrix answering two questions not covered in any existing ASEAN guide: what specific licenses, QMS certifications, warehouse infrastructure, and pharmacovigilance setup must your distributor hold in each of the 6 major ASEAN markets, and which countries accept FDA or NMPA test reports without full retest.

How to classify four common borderline products — hand sanitizer, mouthwash, personal lubricants, and data recorders — across FDA, EU MDR, Brazil ANVISA, and Mexico COFEPRIS. Includes decision trees, regulation citations, and jurisdiction-by-jurisdiction comparison tables.

Strategic analysis of dual CE Mark + FDA 510(k)/PMA approval showing the multiplier effect across 25+ markets, country grouping matrix, and concrete cost/timeline comparisons for manufacturers pursuing both pathways.

The complete guide to drug-device combination product regulation — FDA jurisdiction (OCP, RFD, 21 CFR Part 4), EU MDR Article 117, Notified Body Opinions, QMSR changes, CGMP requirements, market pathways, and post-market obligations.

A strategic map of 25+ countries where CE marking provides regulatory leverage — organized by mechanism: full reliance, abridged review, evidence-only acceptance, and reference-only. Know which markets your CE Mark unlocks and what extra steps remain.

Busting the two biggest myths about Indonesian medical device registration — which devices actually need BPJPH Halal certification (not all of them), and whether CDAKB is a foreign manufacturer obligation or a local distributor obligation.

Operational playbook for manufacturers that missed the May 26, 2024 Notified Body written agreement deadline under Regulation (EU) 2023/607 — covering legal status of non-qualifying devices, market withdrawal timelines, fresh MDR application routes, sell-off rules, and specific examples by device class.

A narrow operational guide to transferring your Authorized Representative under the Saudi SFDA MDMA system — step-by-step process, 2026 fee schedule, multi-AR rules, and escalation options when your current AR refuses to cooperate.

The complete guide to South Korea's Digital Medical Products Act — product categories (digital medical devices, digital-convergence pharmaceuticals, digital health-support devices), MFDS classification, approval pathways, AI/ML requirements, cybersecurity obligations, QMS, and labeling requirements.