Order
Category first, documents second
The same “medical system” can fall into different contours: device, software, service, data. Before collecting a dossier, fix intended use and a category hypothesis. Otherwise the checklist looks complete — and the route does not.
Map
Minimum set
- product and intended use (one paragraph);
- likely authorities / regimes (draft);
- what already exists: certificates, evidence, local analogues;
- what is critically missing (blockers);
- process owner: client / partner / advisor;
- timeline horizon (estimate, not a promise).
Mistakes
What breaks the route
- Copying another country’s checklist without adaptation
- Treating “CE / ISO exists” as enough for local clearance
- Starting UI localization before data and hosting constraints are clear
- Promising a registration date before category audit
Decision
Link to Go / No-go
The regulatory map feeds the decision point. If a critical blocker has no realistic timeline — that is No-go or Adjust the segment, not “one more month of decks”.
Not legal advice. Requirements are re-checked by product category on the project date.
