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International markets and trade
Use current official sources for the jurisdiction and product concerned before comparing market requirements.
Start with the product and jurisdiction
Record the intended purpose, users, configuration and route to market. The same commercial product name can cover functions that fall under different frameworks. A comparison is meaningful only when the functions and dates being compared are clear.
Current source guides
United States: product purpose and general-wellness sources
European Union: intended purpose and medical-device framework sources
Each guide links directly to the issuing authority and states what it does and does not cover.
Build a comparison
For each market, record the responsible authority, official source, version or date, product scope, relevant term and the question that remains. Do not treat an Association sector name as a regulatory category.
Ask about a market source
Include the jurisdiction, product function, source link and passage you are trying to apply. IAHPM can organise a technical discussion; it does not provide an individual authorisation decision.