Medical devices; application for a certificate of marketability

For the export of a medical device, a certificate of marketability of the medical device in Germany is required (Freiverkäuflichkeitsbescheinigung).

Description

Prerequisites

The requirements result from § 10 Medical Device Law Implementation Act (MPDG).

Procedure

The application must be submitted informally by electronic means (e-mail) to the competent authority (see under "Description").

Processing time

The processing time depends on the scope of the documents to be examined.

Required documents

  • Proof of the marketability of the medical devices to be exported (declarations of conformity, certificates from a notified body)

    If there are several products, it is useful to attach a summary in the form of a text or table file.

Forms

Please select a location in "Localization" so that the address of the responsible authority can be filled in.

  • Prefillable Form, Bavaria-wide: Formloser Antrag (ohne Unterschrift)
    Please note

    This form requires no signature. You can sent it electronically (e.g. by secure email or De-Mail) or as hardcopy to the responsible authority.

Fees

  • The fee is set out in the schedule of costs, tariff no. 7.I.9/6, the expenses (e.g. postal delivery charges) are individual. The costs (fee and expenses) are to be borne by the applicant.

Remedy

Administrative court proceedings; information

Administrative court action

Status:01.09.2023

Responsible for editing:Bayerisches Staatsministerium für Gesundheit, Pflege und Prävention

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  • Online transactions, Bavaria-wide
  • Online transactions, locally limited
  • Form, Bavaria-wide
  • Form, locally limited
  • Prefillable Form, Bavaria-wide
  • Legal bases, Bavaria-wide
  • Legal bases, locally limited
  • Fees, Bavaria-wide
  • Fees, locally limited
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Responsible for you

If you select a location under "Localization" the contact details of the responsible authority and, if applicable, locally valid information will be displayed.