Medical Device & IVD Blog

Plan human factors testing for devices with FDA guidance, IEC 62366-1, formative and summative studies, sample sizes, HF submission categories, and review-ready documentation.

Clarifies when Indonesian medical devices need BPJPH Halal certification, how AKD registration works, and why CDAKB obligations usually sit with local distributors.

What manufacturers should do after missing the 2024 MDR Notified Body deadlines, including legal status, withdrawal timing, fresh MDR applications, and sell-off rules.

Use this QMSR gap analysis checklist to map ISO 13485:2016 processes to FDA requirements for terminology, complaints, labeling, UDI, records, and action items.

Operational guide to transferring a Saudi SFDA MDMA authorized representative, covering process steps, 2026 fees, multi-AR rules, and escalation when the outgoing AR will not cooperate.

Guide to South Korea's Digital Medical Products Act, covering DMPA categories, MFDS classification, approval pathways, AI/ML requirements, cybersecurity, QMS, and labeling.

Guide to digital therapeutics regulation in 2026, covering FDA 510(k), De Novo, PMA, EU MDR classification, Germany's DiGA reimbursement route, clinical evidence, and global approvals.

Guide to IEC 60601-1 compliance for medical electrical equipment, covering basic safety, essential performance, collateral standards, EMC, FDA, EU MDR, testing, and Edition 4.

Validate medical device packaging to ISO 11607, including sterile barriers, material qualification, aging studies, distribution simulation, seal testing, and shelf-life claims.

Guide to South Africa SAHPRA medical device registration in 2026, covering establishment licensing, Class A-D classification, ISO 13485, reliance pathways, fees, and AR duties.

Guide to Taiwan TFDA device registration in 2026, covering Medical Devices Act rules, Class I-III classification, QSD, local agents, UDI, fees, and timelines.

Turkey medical device registration guide for 2026, covering TITCK rules, EU MDR/IVDR alignment, UTS registration, representative duties, fees, and timelines.

Guide to Brazil SUS medical device procurement, covering Law 14,133/2021, CONITEC health technology assessment, Compras.gov.br e-procurement, foreign supplier requirements, pricing, and market entry.

Learn how the EU AI Act applies to AI-enabled medical devices, including high-risk classification, MDR/IVDR overlap, conformity assessment, and 2026 deadlines.

Data-driven guide to FDA 510(k) clearance rates, RTA holds, NSE decisions, common failure reasons, and practical strategies to improve first-cycle clearance in 2026.

Navigate Germany's GKV procurement and reimbursement system, including G-DRG, NUB, DiGA, Hilfsmittelverzeichnis, tenders, BfArM, and market access.

Guide to India's medical device procurement channels, including GeM tenders, Make in India rules, CGHS and PM-JAY reimbursement, CDSCO/BIS requirements, and market access.

Guide to Indonesia's e-Katalog procurement system for medical devices, including MoH catalogs, JKN reimbursement, TKDN local content rules, registration, and distributor requirements.

Guide to Japan NHI medical device procurement, covering reimbursement pricing, STM and non-STM categories, DPC bundling, hospital tendering, and foreign supplier market access requirements.

Benchmark medical device regulatory consulting rates by region and consultant tier, with cost drivers and budgeting guidance for registration projects in major markets.