Basic materials for medical devices; application for a declaration of safety
If you need a certificate for presentation to customs or an authority in a third country for the import of basic substances or mixtures containing basic substances or natural products, you can apply for a declaration of no objection.
- You must be a resident of Germany.
- When applying for a declaration of clearance for drop shipments of category 1 precursors, you must be in possession of a permit.
- When applying for a declaration of clearance for a category 2 precursor, you must be in possession of a registration.
You can apply for the declaration of safety informally by e-mail or by mail. The BfArM will review your application. If further information is required, the BfArM will contact you. If you are granted the declaration of safety, the BfArM will send it to you by your preferred method.
The declarations of clearance are usually valid for between 6 and 12 months. In the case of a drop shipment, the period of validity of the declaration of clearance depends on any import permit issued by the consignee.
usually 2 to 3 weeks
Detailed information on how to appeal can be found in the decision on your application.
Links to more information
Responsible for editing:Bundesministerium für Gesundheit
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