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Medical devices - certificate of marketability

Service Description

Manufacturers or authorized representatives placing medical devices on the market for the first time may apply for a certificate of marketability of the medical device(s) for export.

Process flow

The application can be submitted informally by e-mail or by mail.

In addition to the applicant's contact details, the application should contain the following information:

  • the exact designations of all medical devices to be exported (if applicable, with article numbers and/or other additions required for identification)
  • the indication of the country of destination (if this is to be indicated)
  • the language accepted in the country of destination (recipient country) (English, Spanish or French)
  • if applicable, the number of similar certificates of marketability to be issued (in case of certificates without indication of a country of destination)

Who should I contact?

Contact the Thuringian State Office for Consumer Protection (TLV); Department 21 - Technical Consumer Protection, Market Surveillance.

Requirements

The manufacturer or authorized representative must be based in Thuringia and the medical devices to be exported must be indicated in the DIMDI Information System Medical Devices.

Which documents are required?

The manufacturer's current declaration(s) of conformity for the medical devices and the certificate from the Notified Body (except for Class I devices), if these have not already been submitted.

What are the fees?

Fees are charged in accordance with the Thuringian Administrative Cost Regulations for the Ministry of Labor, Social Affairs, Health, Women and Family Affairs (TMASGFF); Part E; No. 2.1.4.

The amount of the fees (80.00 to 500.00 Euro) is differentiated between a first-time issuance and the issuance of a further marketability certificate as well as the number of contained products.

Legal basis

Appeal

informal application

Supporting institutions

Overauthentications (apostille or legalization) for the certificates of marketability are issued if necessary (depending on the requirements in the recipient country) by the:

Thuringian State Administration Office (TLVwA)
Department 200 - Sovereignty affairs
Weimarplatz 4
99423 Weimar

Tel.: 0361 3770-0
Fax: 0361 57 332 1190

Author

The text was automatically translated based on the German content per DeepL.

Technically approved by

Thuringian Ministry of Labor, Social Affairs, Health, Women and Family (TMASGFF)

Professionally released on

24.08.2017

Source: Zuständigkeitsfinder Thüringen (Linie6Plus)

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