Commercialization
130 articles
FDA Pre-Submission Guide: Get Feedback Before a Device Submission
Guide to FDA's Q-Submission program for medical devices, including Pre-Subs, Submission Issue Requests, Information Meetings, feedback requests, content, timelines, fees, and meeting strategy.
Top Medical Device Consulting Firms: Choose a Regulatory & Quality Partner
Compare medical device consulting firms in 2026 across regulatory affairs, quality systems, clinical strategy, market access, pricing, and selection criteria.
Medical Device M&A and Funding: Due Diligence and Valuation Guide
Guide to medical device M&A, venture funding, startup investment, regulatory due diligence, valuation methods, deal structures, and 2026 market trends.
China NMPA Medical Device Registration: The Complete Guide for Foreign Manufacturers
How to register medical devices with China's NMPA — classification, documentation, clinical requirements, testing, timelines, costs, and practical guidance for market entry.
Brazil ANVISA Medical Device Registration: The Complete Guide
How to register medical devices with ANVISA — classification, B-GMP via MDSAP, registration pathways, documentation, fees, and practical guidance for the Brazilian market.
Australia TGA Medical Device Registration: The Complete Guide
How to register medical devices with Australia's TGA — classification, ARTG inclusion, sponsor requirements, MDSAP, fees, and practical guidance for the Australian market.
India CDSCO Medical Device Registration: The Complete Guide
How to register medical devices with India's CDSCO — MDR 2017 classification, import licensing, BIS requirements, clinical evidence, and practical market entry guidance.
Medical Device Registration in Southeast Asia: ASEAN Harmonization & Country Guide
Navigate medical device registration across ASEAN — the AMDD framework, country-by-country requirements for Indonesia, Thailand, Malaysia, Philippines, Vietnam, and Singapore.
Medical Device Reimbursement: The Complete Guide to Coding, Coverage, and Payment
How medical devices get reimbursed — coding systems, CMS coverage pathways, private payer strategy, health technology assessment, and building a reimbursement strategy from day one.
Medical Device Registration in the Middle East: Saudi SFDA, UAE & GCC Guide
How to register medical devices in Saudi Arabia, UAE, and the GCC — SFDA requirements, UAE regulatory framework, GCC harmonization, and practical market entry guidance.