Regulatory

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.

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.

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.

Complete guide to registering medical devices in Pakistan — DRAP Medical Devices Rules 2017, four-tier A/B/C/D classification system, establishment licensing, online e-service portal launched July 2025, authorized representative requirements, dossier preparation, registration fees, labeling in English and Urdu, adverse event reporting, post-market surveillance, and practical timeline and cost estimates.

Guide to selecting, validating, and using patient-reported outcome (PRO) instruments in medical device clinical trials — FDA CDRH draft guidance on fit-for-purpose PROs, EU MDR clinical evaluation requirements, COA types (PRO, ClinRO, ObsRO, PerfO), instrument validation, endpoint hierarchy, and regulatory submission strategies.

Clear guide to the differences between a risk management file and risk management report under ISO 14971:2019 — what each contains, how they relate, traceability requirements, and common audit findings from notified bodies and FDA.

Complete guide to distinguishing SaMD, SiMD, and embedded software for medical devices — IMDRF definitions, IEC 62304 classification, FDA and EU MDR regulatory pathways, MDCG 2019-11 guidance, documentation requirements, and practical decision frameworks for medtech manufacturers.

Practical guide to sample size calculation and justification for medical device clinical investigations — ISO 14155:2026 requirements, EU MDR Annex XV expectations, FDA IDE statistical guidance, superiority vs non-inferiority vs equivalence designs, Bayesian approaches, adaptive sample size re-estimation, pilot study sizing, and worked examples for orthopedic, cardiovascular, and diagnostic accuracy studies.

How much does it cost to register a medical device in Singapore in 2026? A buyer-side breakdown of Singapore Registrant 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 under HSA evaluation routes.

Complete guide to conducting a state of the art (SOTA) review for medical device clinical evaluation under EU MDR — regulatory definitions, SOTA methodology, comparator and benchmark device selection, clinical outcome parameters, MDCG 2020-6 evidence hierarchy, and practical examples for building a defensible CER.

Comprehensive guide to developing a Statistical Analysis Plan (SAP) for medical device clinical trials — ICH E9 and E9(R1) estimand framework, primary and secondary endpoint hierarchy, analysis populations (ITT, PP, safety), missing data strategies (MI, tipping-point), sensitivity and supplementary analyses, multiplicity adjustment, SAP timing and approval, and regulatory expectations from FDA, EMA, and EU MDR for device submissions.

Complete guide to Physician Payments Sunshine Act compliance for medical device manufacturers — covered recipients, reportable payment categories, 2026 thresholds, CMS submission process, state-level requirements, penalties, and audit preparation.

How much does a Swiss Authorized Representative (CH-REP) cost in 2026? Pure Global publishes flat-fee CH-REP rates from $2,000/year for 1 device up to $4,000/year for 5 devices, all classes. Buyer-side breakdown of hourly billing vs registration-fee-plus-annual vs flat all-inclusive fee, with 3-year cash flow scenarios sized to the Swissmedic mandatory device registration deadline of July 1, 2026.

How much does it cost to register a medical device in Thailand in 2026? A buyer-side breakdown of Thai License Holder service pricing — hourly billing, registration-fee-plus-annual, and flat all-inclusive fee — with worked 3-year cash flow scenarios for Class 1/2 listings/notifications and Class 3/4 notifications/licenses.

How much does it cost to register a medical device in the UK in 2026? A buyer-side breakdown of UK Responsible Person (UKRP) service pricing — hourly billing, registration-fee-plus-annual, and flat all-inclusive fee — with worked 3-year cash flow scenarios that incorporate the new MHRA annual GMDN-category fee from April 2026.

U.S. Agent and Official Correspondent fees run $1,000–$5,000+/year on top of FDA's $11,423 annual establishment fee. A buyer-side breakdown of hourly, registration-fee-plus-annual, and flat all-inclusive pricing models — with 3-year cash flow scenarios for foreign manufacturers selling into the United States in 2026.

Complete guide to translating Voice of the Customer (VOC) and user needs into verifiable design inputs for medical devices — 21 CFR 820.30, FDA QMSR, ISO 13485, traceability matrix examples, and best practices for building audit-ready documentation.

How much does it cost to register a medical device in Vietnam in 2026? A buyer-side breakdown of Vietnam Authorized Representative / Marketing Authorization Holder service pricing — hourly billing, registration-fee-plus-annual, and flat all-inclusive fee — with worked 3-year cash flow scenarios for Class A/B notifications and Class C/D registrations under Decree 98/2021 and Decree 07/2025.

Complete guide to medical device registration in the Eurasian Economic Union (EAEU) — national vs EAEU pathway, risk classification (Class I–III), fees, timelines, authorized representative requirements, clinical evaluation, and the 2027/2028 transition deadlines for Russia, Kazakhstan, Belarus, Armenia, and Kyrgyzstan.

Complete guide to GDPR compliance for medical device and IVD manufacturers — special category health data, Data Protection Impact Assessments, DPO requirements, lawful bases for processing, cross-border transfers, and how GDPR intersects with EU MDR, IVDR, and the AI Act.