BfArM - Federal Institute for Drugs and Medical Devices

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105 results

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Privacy policy Date: 30. December 2024 Topics: About BfArM Type: Article

Privacy policy

Code-Search Date: 19. December 2024 Topics: Kodiersysteme Type: Article

Code-Search

New information regarding allocation of DCP slots Date: 17. December 2024 Topics: Licensing Type: Article

Update on allocation of DCP slots

Written renouncement Date: 12. December 2024 Topics: Licensing Type: Article

As of 12.12.2024 online procedures für „Renouncement declarations in accordance with Section 31 sub-section 1 sentence 1 number 2 AMG in conjunction with Section 29 sub-section 1g AMG (Medicinal Products Act)“ and „Declarations of the reasons for the …

Notification obligations of the marketing authorisation holder in accordance with Section 29 sub-section 1g AMG as of 28 October 2013 Date: 12. December 2024 Topics: Licensing Type: Article

As of 12.12.2024 online procedures für „Renouncement declarations in accordance with Section 31 sub-section 1 sentence 1 number 2 AMG in conjunction with Section 29 sub-section 1g AMG (Medicinal Products Act)“ and „Declarations of the reasons for the …

Guidance for the application procedure Date: 12. December 2024 Topics: Medical devices Type: Article

Guidance for the application procedure

As a manufacturer of medical devices, what do I have to bear in mind when I want to launch a new medical device on the German market? Date: 04. December 2024 Topics: Medical devices Type: FAQ

Basic information on getting started in the medical device field and launching medical devices is explained at Basic information.

The monitoring of the manufacture, placing on the market and circulation of medical devices (including their operation …

We are a foreign manufacturer of medical products and would like to market our medical products in Germany as well. Is our CE mark also valid in Germany? Date: 04. December 2024 Topics: Medical devices Type: FAQ

If you have a CE mark for your medical product that is valid for the European market, you can also market the product in Germany.

More information:

FAQ: Do distributors or importers have to notify the distribution of medical devices that are …

We are manufacturers of medical products and require export certificates. Can you provide us with these? Date: 04. December 2024 Topics: Medical devices Type: FAQ

Many countries, such as Colombia or Pakistan, allow the marketing of products that have already been approved for the European market. Therefore, manufacturers must be able to prove that their products can be legally marketed there. These …

DRKS Search Tool Date: 02. December 2024 Topics: About BfArM Type: Article

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