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  • Defective Drugs Medical Devices Injuries Risks and

    Medical device manufacturers issued 1 267 product recalls affecting more than 441 million individual devices in 2018 according to Stericycle Expert Solutions a tech firm that tracks consumer recalls Software issues were the most common reason behind medical device recalls accounting for 296 of

  • Germany s Federal Institute for Drugs and Medical Devices

    Feb 11 2014  The Federal Institute for Drugs and Medical Devices Bundesinstitut für Arzneimittel und Medizinprodukte or BfArM is the medical device regulatory authority in Germany Functioning as an independent body within the Federal Ministry of Health the BfArM deals with the authorization of drugs of medical devices on the basis of the German

  • Q A pharma medical device regulation in GermanyLexology

    Dec 10 2019  A Q A guide to pharma medical device regulation in Germany covering the healthcare bodies and competent authorities marketing authorisation defective and

  • Healthcare Resource Guide GermanyExport govHome

    The German market for medical devices is regulated by German and EU directives standards and safety regulations The EU Medical Device Regulation MDR will take effect on May 26 2020 with increased testing certification and compliance requirements The complementary IVD Regulation will come into effect in May 2022


    These clients benefit from our experience that we gained from supporting hundreds of different molecules in preclinical development Our experience includes food additives small molecules and biotechnology derived drugs vaccines medical devices and drug device combinations all developed in a broad range of clinical indications

  • Products listMerck

    Products list The product websites presented here are intended for use in the United States its territories and Puerto Rico only Other countries may have different regulatory requirements and review practices that may require referencing different information

  • Clinical trials in GermanyLexology

    Dec 19 2018  The applicant or its legal representative with a permanent place of business in the European Economic Area submits a formal application to Federal Institute for Drugs and Medical Devices BfArM

  • The Top 15 Medical Device Companies in the World in 2020

    Johnson Johnson operates three distinct divisionsmedical devices pharmaceuticals and consumer health Both their medical device and pharmaceutical divisions have manufacturing sites in Ireland Johnson Johnson products are marketed in 57 countries via almost 250 operating companiesglobal personnel is approximately 132 200

  • EURECLegislationGermany

    Legislation Germany Medicinal Products Act Pharmaceutical Products Act Drug Law ArzneimittelgesetzAMG especially §§40 42 §77 english german The Act on Medical Devices Medical Devices Act MedizinproduktegesetzMPG especially §§19 24 english german Act ensuring protection of embryos in connection with the

  • BfArMHomepage

    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 Since January 2021 Germany is a member state of SNOMED International

  • HomeMeds Disposal

    The different disposal routes for drugs and medicines in Germany are environmentally conscious and safe As general waste is incinerated in most parts of Germany >80 disposal of unused or expired medicine through general waste is in most areas the safest and recommended route

  • Dornier MedTechA Leading Urological Medical Device Company

    Dornier MedTech headquartered in Munich Germany is a medical device company known for its pioneering technologies and revolutionary therapies in urology Thanks to its deep rooted spirit of entrepreneurship excellence and innovation Dornier thrives while developing some of the highest quality urology products on the market today

  • Want to See the Future of Digital Health Tools Look to

    Dec 02 2020  The Fast Track Process is run by the Federal Institute for Drugs and Medical Devices Bundesinstitut für Arzneimittel und Medizinprodukte or BfArM which plays many of the same roles in Germany


    device manufacturers And apparently the U S Department of Health and Human Services plans to accelerate its investigations of alleged fraud and abuse by medical device companies A violation of the Act can also lead to exclusion from the Medicare and Medicaid programs Prohibitions As most people know kickbacks for referrals of

  • Medical Device Regulations in Germany RegDesk Professional

    Apr 05 2019  The Federal Institute for Drugs and Medical Devices Bundesinstitut für Arzneimittel und Medizinprodukte BfArM is the institution responsible for regulating medical devices in Germany Headquartered in Bonn BfArM operates under the Federal Ministry of Health BfArM also oversees the clinical investigations of medical devices in Germany

  • Medical Protection is the UK s best rated medical

    The Medical Protection Society Limited MPS is a company limited by guarantee registered in England with company number at Level 19 The Shard 32 London Bridge Street London SE1 9SG MPS is not an insurance company All the benefits of membership of MPS are discretionary as set out in the Memorandum and Articles of Association MPS

  • Cybersecurity FDA

    The FDA is informing patients health care providers and manufacturers about the SweynTooth family of cybersecurity vulnerabilities which may introduce risks for certain medical devices 01/23

  • Preclinical and Clinical Trial Requirements Germany

    Jun 28 2019  Prepared in association with Heuking Kühn Lüer Wojtek a leading global law firm this is an extract from The Pharma Legal Handbook Germany available to purchase here for USD 99 1 What is the authorization process for the marketing of new drugs biologics medical devices over the counter medications and other medicinal products 1

  • BfArMAbout us

    About us 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 At the BfArM roughly 1 250 employees physicians pharmacists chemists biologists lawyers engineers technical assistants administrative staff etc are involved in

  • Safety informationInternational Medical Device

    United Kingdom National Patient Safety Alerts Alerts and recalls for drugs and medical devices Alerts and recalls for drugs and medical devices153 alerts for Field safety notice Medical devices regulation and safetyLatest documents 5 Japan Safety Information regarding Medical Devices

  • Drug and Medical Device Registration FAQ

    drug medical device or API inventory has been accounted for reclaimed and/or disposed of properly For each new out of state location attach a copy of the resident state wholesale license

  • About the German Medical Association

    The German Medical Association Bundesärztekammer is the central organisation in the system of medical self administration in Germany As the joint association of the State Chambers of Physicians Landesärztekammer it represents the interests of 506 014 physicians status 31/12/2017 in matters relating to professional policy and plays an active role in opinion forming processes with

  • Federal Institute for Drugs and Medical Devices BfArM

    May 26 2020  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

  • List of national authorities for Medical Devices EU MDR

    Bulgarian Drug Agency Department Control of Medicinal Products and Medical devices 8 Damyan Gruev Str 1303 Sofia Bulgaria Tel 359 2 890 34 83Fax 359 2 890 34 34 e mail bda bda bg Website bda bg

  • Germany bans export of medical protection gear due to

    Mar 04 2020  Germany has banned the export of medical protection gear to avoid supply shortages of masks gloves and suits as doctors and authorities are racing to

  • Medical Products Supplies Cardinal Health

    Medical Products and Supplies Our medical products bridge the gap between the constant need for quality and the increasing demand for savings Our Cardinal Health brand portfolio is a comprehensive offering of clinician preference cost efficient products and physician preferred items with low clinical differentiation helping providers

  • BfSRadiation Protection Act

    May 12 2017  X ray mammography image Source Dr med H Junkermann In Germany mammography examination for the early diagnosis of breast cancer in women between age 50 and age 69 is currently the only screening examination for early diagnosis using X radiation According to the new Radiation Protection Act it is also possible to approve individual early diagnosis measures in future

  • Federal Institute for Drugs and Medical Devices Global

    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 At the BfArM roughly 1 000 employees are involved in licensing improving the safety of medicinal products detecting and

  • The Reimbursement Environment for Medical Devices in France

    Jun 13 2018  USA IDR Medical North America 225 Franklin Street 26th Floor Boston Massachusetts 02110 USA T 1 0 617 275 4465

  • Medical Röchling EN

    Röchling Medical The Medical division offers customers a wide range of high quality customized components and assemblies right through to end to end OEM products The product portfolio also includes standard plastic products with special expertise in the fields of diagnostics fluid management pharma surgery and interventional and much more

  • Pharmaceutical medical device advertising regulation in

    In Germany the rules on advertising for medicines and medical devices are primarily enforced by civil courts If a company allegedly violates a provision of the HWG such violation is at the same time an act of unfair competition

  • Welcome to Dräger USLeading Medical Safety Technology

    Alcohol And Drug Testing frequent questions and to show you product and application information about the usage and the reprocessing of Dräger medical devices and safety protection equipment substances can t be completely controlled respiratory protective equipment must be used Dräger designs respiratory protection devices in

  • Customs onlineMedicinal products and narcotics

    Medicinal products and narcotics To protect the public from health risks and to combat illegal drug trafficking in Germany the trade in medicinal products and narcotics is strictly regulated Here you can find out what to bear in mind if you are in the possession of medicines when travelling

  • Global Regulatory Authority Websites

    Germany Ministry of Health Germany Federal Institute for Drugs and Medical Devices Germany Robert Koch Institute in German Germany Paul Ehrlich Institute in German Germany Federal Institute for Risk Assessment in German Germany Ministry of Consumer Protection Food and Agriculture in German

  • Drugs and Devices Comparison of European and U S

    Aug 01 2016  The Federal Food Drug and Cosmetics Act of 1938 subsequently invested the agency with more rigorous powers to ensure that drugs were not only effective but safe and the FDA was ultimately given authority to regulate medical devices in 1976 through legislation that was later amended in the Medical Device User Fee and Modernization Act

  • Compression Devices Solutions Cardinal Health

    Compression Devices and Solutions Smart Compression is the next evolution of IPC It s designed to move more blood 1 to help prevent stasis 1 track compliance 2 and educate patients and clinicians about the risk of VTE All while thinking about the impact on the environment