Medical Device & IVD Blog

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 Saudi Arabia's HSTP (290 hospitals privatized, private sector 40% to 65%, SAR 260B health budget, LCGPA 40% local content, NIDLP 40% pharma localization) and UAE's Operation 300bn (AED 300B industrial GDP target, DHCC 100% foreign ownership, EDE regulatory framework) are reshaping medical device market entry across the Gulf.

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 data-driven tracker of every major medtech M&A deal in 2025 and 2026 — from Abbott's $21B Exact Sciences acquisition to Boston Scientific's $14.5B Penumbra buy — with deal values, strategic rationale, and industry trends.

A data-driven analysis of why cardiovascular devices dominate medtech M&A — covering the Stryker/Inari, Boston Scientific/Penumbra, and Medtronic/CathWorks deals, the PFA revolution, structural heart innovation, and the forces driving CV dealmaking in 2025-2026.

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 comprehensive guide to medical device company valuation in 2025-2026 — covering EBITDA and revenue multiples by subsector, valuation methods for pre-revenue and commercial-stage companies, deal structures including earn-outs and CVRs, and the due diligence process.

A practical guide to raising venture capital for medical device startups in 2026 — covering typical raise amounts by stage, what investors evaluate, hot subsectors, the VC ecosystem, and how to position for a successful fundraise.

A comprehensive analysis of the wave of medtech divestitures and spinoffs reshaping the industry — from BD's $17.5B Waters deal to J&J's DePuy Synthes separation, Siemens Healthineers deconsolidation, and Medtronic's MiniMed IPO.

A comprehensive analysis of the medtech and healthcare IPO landscape in 2026 — from Medline's record $6.3B listing and Medtronic's MiniMed Diabetes spinoff IPO to digital health debuts, SPAC resurgence, and what's in the pipeline.

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 deep dive into private equity's growing role in medtech — from Blackstone and TPG's landmark $18.3B Hologic take-private to buy-and-build platforms, CDMO acquisitions, the record Medline IPO exit, and PE dry powder deployment strategies.

A comprehensive analysis of the surgical robotics M&A and funding landscape in 2025-2026 — from Intuitive's dominance to the rise of challengers like CMR Surgical, Medtronic Hugo, J&J OTTAVA, and Distalmotion, plus the shift from VC-backed pioneers to PE-led consolidation.

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 Failure Mode and Effects Analysis (FMEA) for medical devices — DFMEA, PFMEA, UFMEA, how FMEA relates to ISO 14971, step-by-step instructions, RPN scoring, and common mistakes to avoid.

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.