The Federal Institute for Drugs and Medical Devices thus makes an important contribution to protecting the population against health risks.Authorisation and Registration of DrugsA focus of the work of the Federal Institute for Drugs and Medical Devices is the authorisation of proprietary medicinal products according to the provisions of the Medicinal Products Act. CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III. The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent higher federal authority within the portfolio of the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG). Since 26 May 2020, DIMDI has been part of the Federal Institute for Drugs and Medical Devices (BfArM). Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom. You will find more detailed information and the possibilities to object to the use of Matomo in our data privacy declaration. CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III. This website uses session cookies to ensure certain functionalities such as downloads or login to closed areas. The Federal Institute for Drugs and Medical Devices (BfArM) is responsible for licensing and registering finished medicinal products as proof of safety and efficacy. Guidelines: N/A National Regulatory Authority National Regulatory Authority present: Yes Name: Federal Institute for Drugs and medical Devices (BfArM) ... the label or in the instructions for use on the medical device. The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent federal higher authority within the portfolio of the Federal Ministry of Health. For the other classes, it depends on the contract with the notified body and the type of device. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Germany, to expedite the preparation of your medical device or IVD registration application. The Federal Institute for Drugs and Medical Devices (BfArM) office Cologne emerged from the German Institute of Medical Documentation and Information (DIMDI), which was incorporated into BfArM on 26 May 2020.The institute provides high-quality information for all areas of the health system via Internet. In order to optimize the website, we use the analysis tool Matomo. The Federal Institute for Drugs and Medical Devices collects and assesses reports on the adverse effects of medicinal products and takes the necessary steps to protect patients.Registering and Assessing Risks Related to Medical DevicesMedical devices are instruments, apparatus, appliances, software, substances and preparations made from substances and other objects for medical purposes intended by their manufacturers for human use, e.g., x-ray machines, cardiac pacemakers, artificial hip replacements, bandages, infusion equipment, catheters, optical aids, condoms, medical instruments and laboratory diagnostics.The main tasks of the Federal Institute for Drugs and Medical Devices involve the central collection, analysis and assessment of risks resulting from the application or use of medical devices and in coordinating any measures that must be taken. The new rules will only apply after a transitional period, namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices. For manufacturers who are either in Germany or have their Authorized Representative located in Germany, devices that have been CE-Marked are required to go through additional registration or regulatory processes, including product registration with the DIMDI (the local German competent authority), in order to receive market clearance. #200-1333 Johnston St., Granville Island, Vancouver, BC V6H 3R9, © Arazy Group Consultants Inc. - is an international consultancy spanning several continents, assisting medical and IVD device companies with regulatory compliance and affairs as they try to enter new markets, AGCI-Standard-NDA-Form-1.doc (6320 downloads). TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I devices. AUTHORIZED REPRESENTATIVE: An authorized representative anywhere in the European Union is required. LICENSE VALIDITY: Licenses issued in the EU are valid for five years. General country-specific regulatory information is provided on this page for medical device registration and approval in Germany. The Federal Institute for Drugs and Medical Devices is an independent specialised federal higher authority within the portfolio of the Federal Ministry of Health.Roughly 1,000 employees – including physicians, pharmacists, chemists, biologists, lawyers, engineers, technical assistants and administrative staff – work at the Federal Institute for Drugs and Medical Devices and authorising new products and improving the safety of drugs, registring and assessing the risks of medical devices and monitoring trade in narcotic drugs and precursors. It cooperates with international institutions to monitor trade in narcotics. The individual tasks of the BfArM office in Cologne are based on different legal principles. The institute also evaluates and develops safe medical devices in Germany. Here you will find our responsible contact persons. You can find current news on classifications of the BfArM office in Cologne as well as older news published by the former DIMDI. It publishes official medical classifications and maintains medical terminologies, thesauri, nomenclatures and catalogues.In addition, it develops and operates database-supported information systems for drugs, medical devices and clinical studies. In this conjunction, the health benefit, i.e., the effectiveness, the safety and the pharmaceutical quality are assessed. The institute provides high-quality information for all areas of the health system via Internet. "Rechsearch drugs" at DIMDI Supporting Information The Information on drugs provides the drug information system of the competent authorities BfArM (Federal Institute for Drugs and Medical Devices), PEI (Paul-Ehrlich-Institut) and BVL (Federal Office of Consumer Protection and Food Safety). Find out about current vacancies and working at BfArM. In addition, the Federal Institute for Drugs and Medical Devices fulfils important tasks within the framework of European drug authorisation.Homeopathic drugs are either registered by the Federal Institute for Drugs and Medical Devices without any information regarding possible applications or authorised for specific applications.Medicinal Product Safety (pharmacovigilance)After medicinal products have been used by numerous patients subsequent to authorisation, adverse effects that may not have been evident in previous testing during the course of the clinical trials mandated for the authorisation process can manifest themselves. In this conjunction, it relies on the reports it receives regarding incidents with medicinal products.Narcotics and PrecursorsThe Federal Opium Agency, which is responsible for granting licenses to legally trade in narcotic drugs and precursors (i.e., for the production of substances suited for use as narcotics) as well as for overseeing their production, cultivation and sale as imports as well as exports is also part of the Federal Institute for Drugs and Medical Devices. ADDITIONAL INFORMATION: On April 5, 2017, two new Regulations on medical devices were adopted, these entered into force on May 25, 2017 and replaced the existing Directives. In Germany, devices are regulated by the The Federal Institute for Drugs and Medical Devices (BfArM) and The German Institute of Medical Documentation and Information (DIMDI), an authority within the German Federal Ministry of Health. Our Matomo installation works without tracking cookies. In Germany, devices are regulated by the The Federal Institute for Drugs and Medical Devices (BfArM) and The German Institute of Medical Documentation and Information (DIMDI), an authority within the German Federal Ministry of Health. BfArM monitors the risks of medicinal products by collecting and evaluating laboratory reports. The implications of the withdrawal for the United Kingdom and the other EU member states depend on the outcome of the negotiations during the transition phase. The experts at the Federal Institute for Drugs and Medical Devices (BfArM) have prepared themselves to take on additional tasks. Darmstadt, Germany, July 26, 2018 – Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced that the German Federal Institute for Drugs and Medical Devices has recommended to approve the company’s new formulation of Euthyrox ® (levothyroxine) in 21 EU countries. The Federal Institute for Drugs and Medical Devices is an independent specialised federal higher authority within the portfolio of the Federal Ministry of Health. The Federal Institute for Drugs and Medical Devices (BfArM) office Cologne emerged from the German Institute of Medical Documentation and Information (DIMDI), which was incorporated into BfArM on 26 May 2020. Starting in 1998, the Federal Institute for Drugs and Medical Devices (BfArM), the German higher federal authority for authorization of most of the medicinal products for human use in Germany, published recommendations for planning and conducting NIS . REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. * Note: If you use your general ISP e-mail address, such as gmail, yahoo etc. Federal Institute for Drugs and Medical Devices Address Kurt-Georg-Kiesinger-Allee 3 53175 Bonn Country Germany Phone +49 228-207-30 Fax +49 228-207-5207 Email poststelle@bfarm.de Website www.bfarm… your LinkedIn profile address is required to process your request. The organisational structure of BfArM can be found here.