Market Access Hub
Register your device in any market, from one documentation system
Each country wants its own dossier. Our country kits give you the same repeatable method everywhere.
3 markets live
Built on primary sources
Instant download
Markets we cover
Three markets live, more in preparation.
BrazilLIVE
ANVISA · RDC 751/2022
3 kits · view market
IndiaLIVE
CDSCO · MDR 2017
2 kits · view market
Saudi ArabiaLIVE
SFDA · MDMA
2 kits · view market
AustraliaSOON
TGA · ARTG
CanadaSOON
Health Canada
JapanSOON
PMDA
ChinaSOON
NMPA
MoroccoSOON
DMP · Ministry of Health
South AfricaSOON
SAHPRA
Rather have it done for you?
Talk to our regulatory experts about your market and your file.
The challenge
Going global multiplies the paperwork
A CE technical file rarely transfers as-is.
Different rules everywhere
Classification, requirements, language and format change by country.
Someone must be local
Most authorities only accept a file through an in-country holder.
One gap costs months
A single missing killer item can stall an otherwise complete file.
The method
The same four steps in every market
01
Read the overview
Framework, classes and pathways.
Free
02
Run the gap analysis
A scored workbook that flags killer items before you file.
from €149
03
Map the requirements
Essential principles mapped to EU MDR GSPR.
from €89
04
Build the technical file
Word templates in the market's dossier structure.
from €249
Complete bundle
Market Gold Kit — all kits for one market, at a saving
Inside the kit
A look inside the gap analysis
Gap_Analysis.xlsx · Dashboard
112
requirements
96
answered
86%
complete
3
killer items open
3 killer items still open
DO NOT FILE
Illustrative. The gate stays red until the last killer item is closed.
Where the kits fit
Kits, consultants or going it alone
| Do it yourself | Full consultancy | MD Regulatory kits | Kits + consulting | |
| Upfront cost | Low | High | Low–moderate | Moderate |
| Speed to a draft | Slow | Moderate | Fast | Fast |
| Expert review | No | Yes | Self-service | Yes, as needed |
| Reusable next time | No | No | Yes | Yes |
Start with the kits, bring us in only where you need it. See how consulting works.
Questions
Frequently asked
You download Excel and Word files, complete the highlighted fields for your device and follow the built-in guidance. No subscription.
No. You may still need an in-country holder to submit — each country page explains when.
Yes. Each requirement points to the matching EU MDR GSPR, so you can reuse existing evidence.
We track each market and revise the kits; every kit states its version and date.
Need a hand?
Want it done for you?
We can review your completed file or take on the full submission.