Medical Device & IVD Blog

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.

The definitive 2026 cost reference for ANVISA medical device registration — exact government fees by class in BRL and USD, BGMP audit costs and schedules, MDSAP carve-outs, ANATEL wireless fees, INMETRO electrical safety certification, and Brazilian Registration Holder retainer ranges.

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.

Role-by-role action playbook for the May 28, 2026 EUDAMED mandatory deadline — covering actor registration, UDI/device registration, certificate uploads, and market surveillance obligations with a countdown checklist and member-state penalty matrix.

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.

The complete guide to human factors testing for medical devices — FDA guidance, IEC 62366-1 usability engineering, formative and summative evaluations, sample size requirements, HF submission categories, and how to prepare documentation that passes regulatory review.

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.

Clause-by-clause gap analysis checklist mapping ISO 13485:2016 to FDA's QMSR — covering terminology changes, complaint handling, labeling controls, UDI integration, record retention, and 50+ specific action items your QMS documents still need.

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.

A complete guide to the regulatory pathway for digital therapeutics — including FDA clearance strategies (510(k), De Novo, PMA), EU MDR classification, Germany's DiGA reimbursement program, approved DTx products, clinical evidence requirements, and what's changing in 2026.

Everything you need to know about IEC 60601-1 compliance for medical electrical equipment — including basic safety, essential performance, collateral and particular standards, EMC requirements, FDA and EU MDR expectations, testing strategies, and what the upcoming 4th Edition means for your device.

Everything you need to know about validating medical device packaging to ISO 11607 — including sterile barrier systems, material qualification, accelerated aging, distribution simulation, seal strength testing (ASTM F88), bubble leak testing (ASTM F2096), dye penetration, shelf-life claims, FDA and EU MDR requirements, and step-by-step validation workflows.

Everything you need to know about registering medical devices in South Africa in 2026 — including SAHPRA requirements, establishment licensing, classification (Class A–D), ISO 13485 mandates, reliance pathways, Authorized Representative obligations, fees, and step-by-step registration instructions.

Everything you need to know about registering medical devices in Taiwan in 2026 — including TFDA requirements, the Medical Devices Act, classification (Class I–III), QSD certification, local agent obligations, UDI requirements, fees, timelines, and step-by-step registration instructions.

Everything you need to know about registering medical devices in Turkey in 2026 — including TITCK requirements, EU MDR/IVDR alignment, classification (Class I–III), UTS electronic registration, Authorized Representative obligations, fees, timeline, and step-by-step registration instructions.

How Brazil's SUS public healthcare system procures medical devices — covering the legal framework (Law 14,133/2021), CONITEC health technology assessment, e-procurement via Compras.gov.br, requirements for foreign suppliers, pricing mechanisms, and strategic recommendations for market entry.

Comprehensive guide to the EU AI Act requirements for AI-enabled medical devices — covering high-risk classification, conformity assessment, the dual compliance model with MDR/IVDR, data governance, transparency, human oversight, and the August 2026 enforcement deadline.