Saint Martin (France)
Product:
In-Vitro Diagnostic Medical Devices Regulation
1. Application form
-Full name, address, email, phone, manufacturer
-Payment
-Proof of authorization in favor of their local representative in Burkina Faso
2. Apply online
3. No need LR, only UE Agent
4. Technical document
-Test reports of conformity issued by accredited laboratories (RF, EMC, Safety)
-Declaration of Conformity
-User manual, design schematics and diagrams
-Technical specification: frequency bands, modulations
-Frequency specification: Technical details of supported frequency bands
-Photographs
5. Accept CE
6. Equipment detail
-Name, brand, model, manufacturer
-Country of origin