Free PDF · United States
FDA Medical Device Approval — 2026 Field Guide
The 510(k), De Novo, and PMA pathways, FY2026 user fees, and how the FDA review clock really runs.
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Short, sourced briefings on the markets manufacturers ask us about most. Every figure traces to a named source.
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Free PDF · Chile
Chile ISP Medical Device Registration — 2026 Field Guide
The March 2026 Decree 25/2026 reset, the 24/36-month implementation ladder, and the ISP conformity route.
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Peru DIGEMID Medical Device Registration — 2026 Field Guide
The 30-day reference lane, the local-holder rule, and the statutory class ladder — with validity and post-market duties.
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Morocco AMMPS Medical Device Registration — 2026 Field Guide
The AMMPS agency, the 120-day decision clock, and the ISO 13485 gate — with the dossier essentials and change rules.
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Qatar MOPH Medical Device Registration — 2026 Field Guide
The GHTF prior-approval gate, the AR import license, and the MOPH filing essentials — with practical notes for your launch plan.
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Oman MOH Medical Device Registration — 2026 Field Guide
The triple establishment gate, the MOH dossier, and the 6–9 month clock — with the import and post-market realities.
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Bangladesh DGDA Medical Device Registration — 2026 Field Guide
The two-step Recipe Approval, the reference-country gate, and the one-holder rule — with local labeling duties.
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Sri Lanka NMRA Medical Device Registration — 2026 Field Guide
The May 2026 GL-037 reset, the 30-day certificate clock, and the recognition pathway — with holder changes and practical notes.
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Kazakhstan Medical Device Registration — 2026 Field Guide
The 2–5 month class ladder, in-country testing, and the EAEU horizon — with fees and validity periods.
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Uzbekistan Medical Device Registration — 2026 Field Guide
Resolution 738, the 155-working-day clock, and the 5-year certificate — with dossier language and practical notes.
Get the guideFree PDF · Kyrgyzstan
Kyrgyzstan Medical Device Registration — 2026 Field Guide
The EAEU 5-in-1 route, the 90-day national clock, and the resident AR — with dossier language and practical notes.
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Jordan JFDA Medical Device Registration — 2026 Field Guide
The 4–8 month EU-model lane, the CE/FDA anchor, and the 5-year certificate — with the mandatory AR rule.
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Bahrain NHRA Medical Device Registration — 2026 Field Guide
The 10-day sprint, the 3-year certificate, and the AR gate — with fees and UDI enforcement.
Get the guideFree PDF · Hong Kong
Hong Kong MDD Medical Device Listing — 2026 Field Guide
The free MDACS listing, the 2026 Stage C mandate, and the LRP — with the two pathways to listing.
Get the guideFree PDF · Global
MDSAP Single Audit Program — 2026 Field Guide
One audit, five regulators, and the 3-year cycle — with the MDSAP practice you need.
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AI SaMD Medical Device Regulation — 2026 Field Guide
The QMSR change, the PCCP lever, and the EU AI Act overlap — with the AI-SaMD practice you need.
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Medical Device Vigilance & Post-Market Surveillance — 2026 Field Guide
The EU reporting clocks, the FDA contrast, and the EUDAMED PMSV module — with the vigilance practice you need.
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IVD Medical Device Registration — 2026 Field Guide
The Class C 2026 milestones, the 80% NB flip, and the class-by-class timeline — with the transition practice you need.
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New Zealand Medsafe Medical Device Notification — 2026 Field Guide
The WAND notification system, the sponsor rule, and the zero-fee reality — with the practice you need.
Get the guideFree PDF · Global
Medical Device UDI Requirements — 2026 Field Guide
The EUDAMED mandatory dates, the new-vs-legacy rule, and the label-data sync — with the global UDI picture you need.
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Turkmenistan Medical Device Registration — 2026 Field Guide
The four-step state registration, the local-representative rule, and the dossier — with the import practice you need.
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Cambodia Medical Device Registration — 2026 Field Guide
The four-step DDF process, the flat fee, and the local-filer rule — with the dossier practice you need.
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Israel AMAR Medical Device Registration — 2026 Field Guide
The four registration routes, the reference-market reliance, and the IRH rule — with the submission practice you need.
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Switzerland Swissmedic Medical Device Registration — 2026 Field Guide
The swissdamed mandate, the CH-REP rule, and the third-country reality — with the market-access implications.
Get the guideFree PDF · Kuwait
Kuwait KFDHA Medical Device Registration — 2026 Field Guide
The mandatory local agent, the bilingual label, and the 90–180-day clock — with the class ladder and renewal duties.
Get the guideFree PDF · Global
ISO 13485 Certification — 2026 Field Guide
The 5-phase timeline, the cost drivers, and how to pick an accredited certification body — the quality foundation every market entry rests on.
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Pakistan DRAP Medical Device Registration — 2026 Field Guide
The LAR-first rule, the abridged lane, and the 21-day reform target — with the conformity-assessment picture.
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Vietnam MOH Medical Device Registration — 2026 Field Guide
Decree 98 in full force, the 90-day clock, and the September 2026 apostille change — with fee and review targets.
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Argentina ANMAT Medical Device Registration — 2026 Field Guide
Disposición 64/2025, the practice timelines, and the Spanish-labeling rule — with HELENA dossier discipline.
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Colombia INVIMA Medical Device Registration — 2026 Field Guide
The 2-day automatic lane, the 90-day clock, and the 2026 UVB fee schedule — with dossier and renewal discipline.
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Kenya PPB Medical Device Registration — 2026 Field Guide
Four routes, the reference-agency ladder, and the local-representative rule — with the timeline ladder.
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Nigeria NAFDAC Medical Device Registration — 2026 Field Guide
The Nigerian representative rule, the inspection gate, and the 120-day clock — with 2026 fee and validity numbers.
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Egypt EDA Medical Device Registration — 2026 Field Guide
The authenticated importer rule, the reliance track, and the local-manufacture route — from the official 2026 EDA guidelines.
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South Africa SAHPRA Medical Device Registration — 2026 Field Guide
The establishment licence, the licence-type matrix, and the recognised-jurisdiction shortcut — with the import-rule reality.
Get the guideFree PDF · Philippines
Philippines FDA Medical Device Registration — 2026 Field Guide
CMDN vs CMDR, the ASEAN abridged route, and the 2026 renewal rule — with the CPR validity reality.
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Thailand FDA Medical Device Registration — 2026 Field Guide
The SKYNET annual renewal, establishment licensing, and the class-based fee map — with the 2026 regulatory changes.
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Indonesia Kemenkes Medical Device Registration — 2026 Field Guide
Izin Edar, the LAR rule, and the October 2026 halal deadline for ASEAN's 280-million-person market.
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Malaysia MDA Medical Device Registration — 2026 Field Guide
The MAH rule, ASEAN reliance routes, and the class-based timeline map for Southeast Asia's fastest second market.
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Taiwan TFDA Medical Device Registration — 2026 Field Guide
The Taiwan agent rule, QSD timelines, and the predicate-device shortcut — with the 5-year licence reality.
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UK MHRA Medical Device Registration — 2026 Field Guide
The UKRP rule, CE transition deadlines, and the reform timeline to 2028 under the 2026 amendment regulations.
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Türkiye TITCK Medical Device Registration — 2026 Field Guide
The EU-aligned framework, ÜTS registration, and the authorized representative rule — with the SGK reimbursement reality.
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Canada Health Canada Medical Device Licensing — 2026 Field Guide
MDL review targets, the MDEL establishment rule, and the 2026 fee schedule under the February 2026 Version 5 guidance.
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Mexico COFEPRIS Medical Device Registration — 2026 Field Guide
The MRH rule, standard vs. equivalency routes, and the 2026 renewal reforms for Latin America's largest market.
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Australia TGA Medical Device Registration — 2026 Field Guide
ARTG inclusion, the mandatory Australian sponsor, and the July 2026 UDI deadline.
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UAE MOHAP/EDE Medical Device Registration — 2026 Field Guide
Marketing authorization with the Emirates Drug Establishment — fees, the 45-working-day timeline, and the MAH rule.
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India CDSCO Medical Device Registration — 2026 Field Guide
The MD-14/MD-15 import route, the mandatory Indian Authorized Agent, and fees by class.
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Japan PMDA Medical Device Registration — 2026 Field Guide
The Todokede, Ninsho, and Shonin routes, the mandatory MAH, and QMS conformance.
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Brazil ANVISA Medical Device Registration — 2026 Field Guide
Cadastro vs. registro, the BRH and BGMP rules, and INMETRO certification for South America's largest market.
Get the guideFree PDF · Europe
EU MDR Medical Device Certification — 2026 Field Guide
Notified-body capacity, Article 120 transition deadlines, and the real CE-marking budget under the MDR.
Get the guideFree PDF · Global
Medical Device Clinical Trials — 2026 Field Guide
When a trial is required, how to design it for FDA acceptance, and what ISO 14155:2026 changes.
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Singapore HSA Medical Device Registration — 2026 Field Guide
Four evaluation routes, the mandatory Registrant, fee tables, and the ASEAN reliance gateway.
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South Korea MFDS Medical Device Registration — 2026 Field Guide
Classes I–IV and the S.E. shortcut, the KLH requirement, KGMP certification, and the 2026 immediate-entry pathway.
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China NMPA Medical Device Registration — 2026 Field Guide
The MDRC pathway by class, the mandatory China legal agent, local testing rules, and realistic timelines.
Get the guideFree PDF · Global
Find & Vet Medical Device Distributors — 2026 Field Guide
Where strong distributors are found, a one-sheet vetting checklist, and the contract clauses that decide everything.
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Saudi Arabia SFDA Medical Device Registration — 2026 Field Guide
The MDMA pathway, the mandatory Authorized Representative, the 4-day MDNR fast lane, and post-approval obligations.
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Ethiopia Medical Device Registration — 2026 Field Guide
The WHO-EFDA ML3 roadmap, 848 H1 2026 approvals, and how filing works through the eRIS portal.
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