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.

Description

Prerequisites

  • 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.

Procedure

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.

Deadlines

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.

Processing time

usually 2 to 3 weeks

Required documents

  • Required Documents

    Für Mischungen oder Naturprodukte:

    • Analysenzertifikat oder Sicherheitsdatenblatt oder beides
    • bei Streckengeschäften mit Grundstoffen der Kategorie 1: Kopie der Einfuhrgenehmigung des Empfängers im Drittland

Fees

  • There are no fees for you.

Remedy

  • Appeal.
    Detailed information on how to appeal can be found in the decision on your application.

Status:23.06.2022

Responsible for editing:Bundesministerium für Gesundheit

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