Pure Global: Flat Annual Fees.
Transparent Pricing.
Medical Device & IVD Registration Services with simple, flat annual fees. Powered by Pure Global AI for unprecedented transparency. Instant pricing for 13 markets below, with 30+ additional markets available.
Simple Flat Annual Fees
Medical Device & IVD registration from $1,000/year
All-Inclusive
Rep, registration, translations, renewals
30+ Global Markets
Instant pricing for 13 markets, customized for 30+
Calculate Your Price
Select countries and configure your requirements to see instant pricing
1-10 listings
Applies to all countries
Americas
Europe & Middle East
Asia Pacific
Choose the markets you want to register in
Select countries to calculate pricing
Choose from 13 global markets
What's Included in Your Flat Annual Fee?
As your In-country Representative, everything you need for medical device & IVD registration
Local Representation
Authorized representative services in your target market
Device Registration Compilation
Complete compilation of device registration(s), including any required translations
Dossier Submission
Submission of the dossier(s) to the local authorities for review and approval
Import Authorizations
Generate import authorizations to local distributors/importers (if applicable)
Post-Approval Support
Filing of post-approval modifications and annual renewals
Post-Market Surveillance
Post-market surveillance correspondence with local authorities
Contract Terms
- •Three-year contract required. Early contract termination is possible with 50% payoff of the remaining contract value. When preferring a one-year contract, pay a 50% higher fee in the first year.
- •Custom Pricing: When more than 10 listings, we will generate custom pricing tailored to your needs.
Fees Not Included
- •Government fees and other required third party fees are not included in the annual fee
- •Additional fees apply when the In-country Representative handles the importation
Powered by Pure Global AI
Our AI-powered platform automates documentation, ensures compliance, and provides real-time regulatory updates - allowing us to offer transparent, flat annual fees instead of traditional hourly consulting rates.
Why Transparent Pricing Matters
After 20+ years in MedTech regulatory services, we believe pricing should be simple, fair, and transparent.
Budget with Confidence
No surprise fees, no hidden costs. Know exactly what you'll pay before you commit.
Compare Markets
Evaluate markets side-by-side instantly. Make data-driven decisions.
Scale Efficiently
See pricing for 1 to 10 listings instantly. Plan your portfolio expansion.
Instant Self-Service
No need to wait for quotes. Get your pricing immediately.
Pricing Questions Answered
Everything you need to know about our transparent pricing
Ready to Get Started?
Join 500+ MedTech companies using Pure Global for transparent, affordable global market access.
