Published at: 2026-10-12
Medical device validation rules and limits
Review known rules for authorization, orders, and inventory.
Overview
This page summarizes GSP checks, authorization duplicate checks, channel outbound rules, and compliance limits.
Qualification and order validation
Admins can select these GSP checks:
- Initial qualification validity
- Product registration certificate validity
- Dealer authorization agreement validity
- Authorized product scope
After you enable a check, the system runs it when an order is submitted. If a condition fails, the system blocks submit and shows the reason.
Authorization rules
| Rule | Description |
|---|---|
| Product dimension | You can authorize by product registration certificate or product category |
| Region dimension | You can authorize by province, city, or hospital |
| Duplicate check | The same product-dimension and region-dimension combination is checked for duplicates |
| Hospital authorization | The same certificate or product cannot have more than one dealer authorization for the same hospital |
| Multiple hospitals | Public cloud allows at most 10 hospitals in one selection by default |
Outbound rules
- When you ship to a dealer, one outbound order supports only one dealer.
- When you ship to hospitals, you can enter multiple hospitals in the details.
- Multi-level channel flow depends on the DMS multi-level distribution plugin.
Other limits
- OCR is a paid capability. The system does not include preset OCR for terminal invoices.
- A manufacturer outbound order must sync from ERP to CRM before a channel inbound order can be created.