Reimbursement & Market Access
76 articles
Best Regulatory Intelligence Software for Medical Devices 2026: Unbiased Comparison of 8 Platforms
An independent comparison of the top regulatory intelligence platforms for medical device and IVD manufacturers in 2026 — covering RegDesk, IQVIA, Cortellis, Obsidian, Basil Systems, ArisGlobal, Freyr RegIntel, and Veeva Vault Regulatory.
Kenya Medical Device Registration Guide (2026): PPB Process, Fees, Timelines, Reliance Pathways & Requirements
Complete guide to registering medical devices in Kenya through the Pharmacy and Poisons Board (PPB) in 2026 — including classification (Class A–D), evaluation routes (full, abridged, expedited, immediate), reliance pathways, local authorized representative requirements, import permits, QMS audits, post-market surveillance, and step-by-step registration instructions.
PMDA eCTD v4.0 for Medical Devices: Complete Transition Guide After the April 2026 Mandate
Japan's PMDA made eCTD v4.0 mandatory on April 1, 2026. This guide covers what changed, Japan-specific Module 1 requirements, medical device submission differences, and how to prepare compliant submissions.
CMS-FDA RAPID Coverage Pathway: Fast-Track Medicare Coverage for Breakthrough Devices
On April 23, 2026, CMS and FDA announced the RAPID pathway — a new initiative that could deliver Medicare national coverage within 60–90 days of FDA authorization for eligible Breakthrough Devices. This guide explains eligibility requirements, how the pathway works, IDE study design implications, and what manufacturers must do to prepare.
Australia Medical Device Registration Cost 2026: Australian Sponsor Pricing Models, Flat Fee vs Hourly Billing, and 3-Year Cash Flow Comparison
How much does it cost to register a medical device in Australia in 2026? A buyer-side breakdown of Australian Sponsor service pricing — hourly billing, registration-fee-plus-annual, and flat all-inclusive fee — with worked 3-year cash flow scenarios for ARTG inclusion across Class I through Class III/AIMD devices.
Bangladesh DGDA Medical Device Registration Guide: Classification, Import Permits, and Local Representative Requirements
Complete guide to registering medical devices in Bangladesh through the Directorate General of Drug Administration (DGDA) — four-tier risk classification (A–D) aligned with ASEAN MDD, two-step Recipe Approval and Final Registration process, reference country Free Sale Certificate requirements, local authorized representative obligations, import licensing and indent approval workflow, Maximum Retail Price (MRP), Bengali labeling, ISO 13485 QMS expectations, Drug and Cosmetics Act 2023, fees, timelines, and South Asia market strategy.
Brazil Medical Device Registration Cost 2026: BRH Pricing Models, Flat Fee vs Hourly Billing, and 3-Year Cash Flow Comparison
How much does it cost to register a medical device in Brazil in 2026? A buyer-side breakdown of Brazilian Registration Holder (BRH) service pricing — hourly billing, registration-fee-plus-annual, and flat all-inclusive fee — with worked 3-year cash flow scenarios for Class I/II notifications and Class III/IV registrations.
Colombia Medical Device Registration Cost 2026: INVIMA Representative Pricing Models, Flat Fee vs Hourly Billing, and 3-Year Cash Flow Comparison
How much does it cost to register a medical device in Colombia in 2026? A buyer-side breakdown of Colombia Representative (Representante Legal) service pricing — hourly billing, registration-fee-plus-annual, and flat all-inclusive fee — with worked 3-year cash flow scenarios for Class I/IIa uncontrolled and Class IIb/III controlled pathways.
Costa Rica Medical Device Registration Guide: Ministry of Health Process, Spanish Documentation, and LATAM Strategy
Complete guide to registering medical devices in Costa Rica — Ministry of Health (Ministerio de Salud) process under Decree No. 34482-S, four-tier classification based on Health Canada rules, two-phase legal and technical review, simplified pathway for FDA-cleared devices, Registration Holder requirements, Free Sale Certificate, Spanish labeling and IFU obligations, import permits, fees, timeline, and Central America market strategy.
CPT, HCPCS, and ICD Coding Strategy for Medical Devices: Reimbursement Pathway Guide
Complete guide to CPT, HCPCS, and ICD coding strategy for medical device manufacturers — how each code set works, when to seek new codes, Category III vs Category I pathways, AMA application process, CMS payment systems, and practical strategies for securing adequate reimbursement.
European Union Medical Device Registration Cost 2026: EC REP Pricing Models, Flat Fee vs Hourly Billing, and 3-Year Cash Flow Comparison
How much does it cost to register a medical device in the European Union in 2026? A buyer-side breakdown of EU Authorized Representative (EC REP) service pricing — hourly billing, registration-fee-plus-annual, and flat all-inclusive fee — with worked 3-year cash flow scenarios for MDR and IVDR portfolios.
Hong Kong Medical Device Registration Cost 2026: LRP Pricing Models, Flat Fee vs Hourly Billing, and 3-Year Cash Flow Comparison
Hong Kong medical device registration in 2026: USD 6,000–18,000 over 3 years for MD Class II / IVD B and USD 9,000–40,000 for Class III–IV / IVD C–D under voluntary MDACS — entirely LRP service fees, since government fees are zero. Pure Global flat fee from USD 2,000/year. Hourly, reg+annual, and flat-fee models compared with 3-year cash flow, switching playbook, and Medical Device Bill transition coverage.
Hong Kong Medical Device Registration Guide: MDACS Listing, Local Responsible Person, and Transition Planning
Complete guide to registering medical devices in Hong Kong — MDACS voluntary listing process, LRP requirements, GHTF/IMDRF classification (Class I–IV, IVD Class A–D), reference country pathways, Stage C mandatory procurement rules effective March 2026, upcoming Centre for Medical Products Regulation, timeline, fees, and transition strategy.
Indonesia Medical Device Registration Cost 2026: LAR Pricing Models, Flat Fee vs Hourly Billing, and 3-Year Cash Flow Comparison
How much does it cost to register a medical device in Indonesia in 2026? A buyer-side breakdown of Indonesia Local Authorized Representative (LAR) service pricing — hourly billing, registration-fee-plus-annual, and flat all-inclusive fee — with worked 3-year cash flow scenarios for AKD/AKL devices and the 2% importation fee mechanic.
Malaysia Medical Device Registration Cost 2026: MAR Pricing Models, Flat Fee vs Hourly Billing, and 3-Year Cash Flow Comparison
How much does it cost to register a medical device in Malaysia in 2026? A buyer-side breakdown of Malaysia Authorized Representative (MAR) service pricing — hourly billing, registration-fee-plus-annual, and flat all-inclusive fee — with worked 3-year cash flow scenarios for Class A/B and Class C/D devices, plus the CAB-MDA-MAR three-fee structure decoded.
Medical Device Distribution Agreements: Regulatory Clauses, Importer Duties, and Territory Control
Complete guide to medical device distribution agreements — regulatory clauses, EU MDR Article 14 importer obligations, FDA initial distributor requirements, exclusivity and territory provisions, PMS and vigilance obligations, quality agreements, and negotiation strategies for medtech manufacturers.
Medicare NCD vs LCD for Medical Devices: Coverage Determination Strategy and Evidence Requirements
Complete guide to Medicare National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) for medical device manufacturers — how each process works, evidence requirements, timelines, the new RAPID pathway, Coverage with Evidence Development, MAC jurisdictions, and practical strategies for securing Medicare coverage.
Mexico Medical Device Registration Cost 2026: MRH Pricing Models, Flat Fee vs Hourly Billing, and 3-Year Cash Flow Comparison
Pure Global publishes Mexico MRH service at $2,000/year flat for Class I and $3,000/year for Class II/III — versus $15,000–$30,000 Year 1 under hourly billing. A buyer-side breakdown of Mexico Registration Holder (MRH) pricing models with 3-year cash flow scenarios, switching playbook, and RFP template for COFEPRIS submissions and the Equivalence Pathway.
New Zealand Medsafe Medical Device Registration Guide: WAND, Sponsor Duties, and Reliance Pathways
Complete guide to registering medical devices in New Zealand — Medsafe WAND database notification process, sponsor requirements, GHTF classification, adverse event reporting, labeling obligations, TTMRA mutual recognition with Australia, and practical timeline and cost estimates for market entry.
NTAP Application Guide for Medical Devices: New Technology Add-On Payment Criteria, Timeline, and Strategy
Complete guide to CMS New Technology Add-On Payment (NTAP) for medical device manufacturers — eligibility criteria (newness, cost, substantial clinical improvement), traditional vs alternative pathways, FY 2027 application timeline, MEARIS submission, Town Hall process, payment calculation, and proposed changes to Breakthrough Device fast-track pathways.