Excel instead of manual single entry
Import structured product data into the GSP via pre-configured Excel templates.
GSP Starter Program
12 Months transfer up to 100 UDI-DI records free of charge
Manage, validate, and transmit your first 100 UDI-DIs for a selected authority with a professional, scalable solution.
The one-time technical setup is subject to a fee. Additional UDI-DIs, authorities, mandates, and additional services will be charged according to an individual quote.
From Excel to Authority
Manage UDI submissions structured and transparently
The Global Submission Portal supports regulatory affairs and quality management in checking, transmitting, and tracking UDI data.
Automatic Validation
Detect missing, formally incorrect, or implausible data prior to transmission.
M2M Submission
Electronically transmit validated data to the selected authority, if available there.
Status and Feedback
Track processing status and receive official error texts structured.
Audit Trail and Publication Report
Document changes, transmissions, and published data for internal records.
Modularly Expandable
Add additional UDI-DIs, authorities, manufacturer units, or mandates as needed.
How to start
Productive use in four steps
We jointly check the required scope and guide your company through the technical setup.
Send Request
You provide us with the authority, UDI volume, and number of mandates.
Receive Offer
You receive the specific price for additional UDI-DIs and the follow-up price from year two.
Perform Setup
Authority access, mandate, and technical connection are established for the selected module.
Transmit Data
You upload your data, validate it, and track submissions and feedback in the GSP.
Full Cost Transparency
What is included in the starter year
Companies with larger portfolios are also welcome to participate. From the 101st UDI-DI onward, only the additional volume will be charged according to an individual quote.
One selected authority
0 EUR
Up to 100 UDI-DIs
0 EUR
One-time technical setup
49 EUR
Additional UDI-DIs from the 101st UDI-DI
according to individual quote
Additional authority, SRN, CHRN, or mandate
according to individual quote
After twelve months, the contract will be continued as a regular paid GSP annual contract unless it is canceled at least 30 calendar days before the end of the starter year. The specific follow-up price will already be stated in the individual quote.
Who is it suitable for?
From the first product portfolio to larger data inventories
The starter program is not limited to companies with a maximum of 100 UDI-DIs.
Particularly useful if you …
- want to transmit UDI data to an authority for the first time,
- currently work with Excel, XML, or manual portals,
- want to technically check data before submission,
- need status and authority feedback centrally,
- want to start with up to 100 UDI-DIs and grow later.
Larger portfolios are also welcome
- The first 100 UDI-DIs are in the starter quota.
- Additional UDI-DIs are charged according to an individual quote.
- Additional authorities and mandates can be added.
- The scope is transparently offered before contract conclusion.
- There is no limitation on the number of participants.
FAQ
The most important facts about the starter program
Is the GSP starter program completely free of charge?
No. In the first contract year, the GSP license fee is waived for a selected authority and up to 100 UDI-DIs. The one-time technical setup as well as additional UDI-DIs, authorities, mandates, and additional services are subject to a fee.
Can companies with more than 100 UDI-DIs participate?
Yes. The first 100 distinct UDI-DIs are in the starter quota. All further UDI-DIs will be calculated according to an individual quote.
What counts towards the 100 UDI-DIs?
Counted are distinct UDI-DIs or the corresponding authority-specific product identifiers. Corrections and updates of an already recorded UDI-DI as well as technically necessary repetitions do not count again. Necessary higher-level identifiers such as Basic UDI-DIs are generally not credited toward the 100 UDI-DIs unless otherwise agreed in the individual quote.
Which authorities can I use the starter program for?
You select a supported UDI module: EUDAMED, swissdamed, FDA GUDID, or TGA AusUDID. Additional authorities can be commissioned separately.
Are data preparation and regulatory consulting included?
No. The campaign includes the agreed GSP usage. Data preparation, manual data entry, regulatory consulting, individual training, interfaces, and other additional services are only included after a separate commission.
What happens after the twelve months expire?
The contract will be continued as a regular paid GSP annual contract unless it is canceled at least 30 calendar days before the end date stated in the quote. The follow-up price and scope of services are transparently agreed upon when concluding the starter contract.
When do the twelve months begin?
The binding start and end date are specified in the individual quote. This ensures that it is clear before contract conclusion when the starter year begins and by when cancellation is possible.
Request without obligation
Does the starter program fit your UDI project?
Send us your key data. We will review your requirements and get back to you with the appropriate scope of services and specific terms.
- One selected authority in the starter program
- Up to 100 UDI-DIs in the starter quota
- Larger portfolios explicitly possible
- Setup, additional quantities, and follow-up price transparent in advance