AUPAM · MEDICAL TECHNOLOGY
Global market desk
Compare 12 device markets and build a practical, source-linked action plan for your product.
What are you working on?
These choices shape a preparation plan. They do not assign a regulatory class or grant market authorisation.
Your next steps
Add a supporting record and reviewer before marking a task documented. This tracks your work, not regulatory compliance.
Plans are kept separately for each market, task and product combination. Notes stay in this browser; the selection link contains choices only.
Compare like with like.
Choose up to three markets. Review the same five planning questions for each.
A class, certificate or permission in one market does not automatically settle another market’s requirements. Verify current local rules for the exact product.
Sources you can inspect.
Official source pages checked on 3 October 2026. These concise orientation notes are an original AUPAM synthesis; the linked authority controls the requirements and later revisions.
The desk covers 12 selected markets, including four Arab markets. It is not a complete global or 22-country legal register. Fees, submission deadlines and device-specific decisions must be checked at source.
Saudi Arabia SFDA
Checked: 3 October 2026 · Scope: linked source pages. Open the document to confirm its edition and effective date.
United Arab Emirates EDE
Checked: 3 October 2026 · Scope: linked source pages. Open the document to confirm its edition and effective date.
Egypt EDA
Checked: 3 October 2026 · Scope: linked source pages. Open the document to confirm its edition and effective date.
Oman Ministry of Health / DSC
Checked: 3 October 2026 · Scope: linked source pages. Open the document to confirm its edition and effective date.
United States FDA
Checked: 3 October 2026 · Scope: linked source pages. Open the document to confirm its edition and effective date.
European Union European Commission / national authorities
- European Commission — MDR and IVDR overview
- European Commission — economic operators
- European Commission — EUDAMED
Checked: 3 October 2026 · Scope: linked source pages. Open the document to confirm its edition and effective date.
Great Britain MHRA
Checked: 3 October 2026 · Scope: linked source pages. Open the document to confirm its edition and effective date.
Canada Health Canada
Checked: 3 October 2026 · Scope: linked source pages. Open the document to confirm its edition and effective date.
Australia TGA
Checked: 3 October 2026 · Scope: linked source pages. Open the document to confirm its edition and effective date.
Japan PMDA / MHLW
Checked: 3 October 2026 · Scope: linked source pages. Open the document to confirm its edition and effective date.
Singapore HSA
Checked: 3 October 2026 · Scope: linked source pages. Open the document to confirm its edition and effective date.
Brazil ANVISA
Checked: 3 October 2026 · Scope: linked source pages. Open the document to confirm its edition and effective date.
How to use the plan responsibly
Use this as a working checklist with your controlled procedures. The plan is rule-based and does not evaluate uploaded dossiers. Mark “not applicable” only with a reason and reviewer. It does not cover all special-access, custom-made or investigational routes. Use your organisation’s secure systems for confidential files and patient information. Browser backups are separate from the Centre’s reading-list and academy backups.
From source to practice
Prepare your scientific review with clear steps
16 guides across quality, manufacture, registration, safety and research, with scope, source versions and saveable working checklists.