Commercialization

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.

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.

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.

Guide to Saudi Arabia's NUPCO medical device procurement, including framework tenders, SFDA registration, localization requirements, Wasfaty integration, and foreign manufacturer strategy.

Guide to US public-sector device procurement through GPOs, VA Federal Supply Schedules, DoD channels, GSA contracts and SAM.gov registration.

Guide to INVIMA medical device registration in Colombia, including classification, controlled and uncontrolled pathways, UDI-DI, fees, legal representation, and PMS.

Plan a realistic 2026 CE marking budget under EU MDR, including notified body fees, clinical evaluation, technical documentation, ISO 13485, and ongoing compliance.

Plan FY 2026 medical device user fees with MDUFA V fee amounts, small business reductions, PMA waivers, registration fees, and cost controls.

Evaluate medical device regulatory consultants with selection criteria, interview questions, red flags, pricing benchmarks, RAC/RAPS signals, and a stage-based decision framework.

Compare in-house, outsourced, and hybrid regulatory affairs models for medical device companies, with 2026 cost benchmarks, market data, stage-based fit, and decision guidance.

Guide to registering medical devices in Indonesia, covering BPOM/MoH classification, CSDT dossiers, Regalkes submissions, local representatives, Halal deadlines, and market entry.

Breakdown of ISO 13485 certification costs and timelines, including certification body fees, consulting rates, surveillance audits, hidden expenses, and cost-saving strategies.

Register medical devices with Mexico COFEPRIS, including classification, standard and equivalency routes, registration holder duties, fees, fast-track options, and 2026 market entry planning.

Budget FDA PMA submissions for Class III devices with FY 2026 user fees, clinical trial costs, testing, consulting, post-market obligations, and planning benchmarks.

Budget a 510(k) submission with 2026 FDA user fees, testing, consulting, hidden costs, small business savings, and practical cost-control strategies.

Guide to FDA Breakthrough Device Designation in 2026, including eligibility criteria, Q-Submission application steps, program benefits, timelines, statistics, and pathway strategy.