slovenia e labeling medical devices

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  • Slovenia Medical Device Registration - JAZMP

    In Slovenia, devices are regulated by the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP). CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III. TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I devices.

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  • Benefits and Challenges of e-labeling for Medical

    e-labeling plays a critical role in the medical devices industry, as it ensures to improve operational efficiency, maintain brand consistency, obtain compliance and support business growth. Hence, the device industry is moving towards adopting end-to-end e-labeling life cycle procedures, starting from label content creation to review and approvals. How are they beneficial and what kind of ...

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  • JAZMP – Agency for Medicinal Products and Medical

    e-applications INTRODUCTION Our primary mission is to protect public health through the regulation and supervision of medicinal products, medical devices, blood, tissues and cells and associated activities in the private and public sector.

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  • Device Labeling | FDA

    2020-10-23 · Labeling regulations pertaining to medical devices are found in the following Parts of Title 21 of the Code of Federal Regulations (CFR). General Device Labeling - 21 CFR Part 801 Use of Symbols ...

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  • Labeling Medical Devices | Greenlight Guru

    2021-6-15 · If your medical device company is planning to sell devices in the United States, you will need to comply with the FDA QSR for Labeling and Packaging Control of medical devices, found in 21 CFR Part 820.120. The focus of these controls is to ensure that labels are accurately designed and properly applied to the correct products.

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  • Medical Device Labeling - FDA

    2018-10-8 · Medical Device Labeling FDA Small Business Regulatory Education for Industry (REdI) Silver Spring, Maryland September 29, 2015 Eric Richardson, M.S.

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  • Worldwide Language Requirements for Medical

    2019-5-24 · ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes ISO 15223-1:2016 Medical Devices — Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied — Part 1: General Requirements ISO 14971:2012 Medical Devices - Application of Risk Management to Medical Devices

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  • Principles of Labelling for Medical Devices and IVD ...

    2018-1-1 · Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1: Apr 21, 2021: A: Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3: Feb 23, 2021: N: FDA UDI - Label vs. Labeling - Does the insert ...

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  • Medical Devices Labeling - Freyr Solutions

    Overview Medical device manufacturers face an array of challenges in delivering their products to domestic and international markets. With potential risks to patient safety, Regulatory review, and ultimately brand equity, organizations must ensure that medical device labeling documentation complies with the current medical device labeling standards prevalent in each country where the device is ...

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  • Slovenia - Medical Equipment

    2020-7-22 · As a result of limited and/or highly specialized domestic production, Slovenia’s health care equipment market is dependent on imports from Germany, Italy, Austria, Switzerland, and the United States. U.S. exporters account for between 15 and 20 percent of Slovenia’s USD 450 million medical equipment market.

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  • Symbols for use in the labelling of medical devices

    2008-7-21 · Symbols for use in the labelling of medical devices ... Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. I.S. EN 980:2008 This is a free 6 page sample. Access the full version online. SAI Global also carries a wide range of publications from a wide variety ...

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  • Understanding Medical Device Labeling Regulations

    As medical technology advances to a point where the average human lifespan increases, it produces a world in which medical devices are more widely seen in the world. This has brought into focus the need for clear and accurate labeling on medical devices for safe use and user information.

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  • HEALTHCARE AND MEDICAL DEVICES E-SSENTIALS -

    For medical devices, personal protection equipment, and some other products, conformity assessment must be carried out by a Notified Body. Depending on the directive, conformity assessment may comprise product testing and factory inspection, or only an audit of the manufacturer’s quality management system.

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  • Pucer Anja Stegne 7 Ljubljana, SI-1000 Regulation

    2021-5-4 · requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809; medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or post-marketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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  • Medical Devices - Stryker MedEd

    Medical Devices Stryker is one of the world’s leading medical device companies. We offer a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnoloy and spine products to help people lead more active and satisfying lives.

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  • Mandatory Language Requirements For Medical Devices

    2020-6-11 · Mandatory Language Requirements for Medical Devices Basis: National laws relating to the Medical Devices Directive 93/42/EEC Country for Label and Display for Safety Instruction for instruction for use Austria German German German, exception for professional use possible Belgium French, Dutch or German, depending on local area ditto ditto

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  • Medtronic hiring Regulatory Affairs Specialist -

    2021-5-26 · We are currently looking for a responsible for Regulatory Affairs in Slovenia. In this position you will ensure that all regulatory and quality requirements necessary to obtain timely regulatory approvals (e.g commercial medical devices) within country are met and quality questions for any Medtronic distributed product and properly addressed.

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  • FDA Regulations For Medical Devices in the United

    2020-5-6 · Depending on different types of medical devices, importers can refer to the applicable requirement for their labeling here. Good Manufacturing Practice (GMP) Medical devices that are subject to premarket notification or exempt from notification, are required to comply with CFR Title 21 Part 820, which is a quality system regulation. The Current ...

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  • Understanding Medical Device Labeling Regulations

    As medical technology advances to a point where the average human lifespan increases, it produces a world in which medical devices are more widely seen in the world. This has brought into focus the need for clear and accurate labeling on medical devices for safe use and user information.

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  • Slovenia - Pharmaceuticals - Trade

    2020-7-22 · Agency for Drugs and Medical Devices, Ptujska 21, 1000 Ljubljana, Slovenia . E-mail: [email protected] National Institute of Public Health, Trubarjeva 2, 1000 Ljubljana, Slovenia. E-mail: [email protected] Chamber of Commerce and Industry of Slovenia, Dimiceva 13, 1504 Ljubljana, Slovenia E-mail: [email protected] U.S. Commercial Service

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  • MultiLingual Computing, Inc. • 319 North First Avenue ...

    2015-12-17 · E-labeling Electronic labeling or e-labeling is an option for manufacturers of certain med-ical devices, and one that is set to enjoy a wider adoption supported by a new regulation in the EU. The Commission Regulation (EU) No 207/2012 applies to certain professional devices under MDD or AIMDD and will come into effect on March 1, 2013.

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  • export.gov

    2021-6-17 · Agency for Drugs and Medical Devices, Ptujska 21, 1000 Ljubljana, Slovenia E-mail: [email protected] National Institute of Public Health, Trubarjeva 2, 1000 Ljubljana, Slovenia E-mail: [email protected] Chamber of Commerce and Industry of Slovenia, Dimiceva 13, 1504 Ljubljana, Slovenia E-mail: [email protected] U.S. Commercial Service

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  • ISO 15223-2 - European Standards

    ISO 15223-2. ISO 15223-2:2010 specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1. The purpose of ISO 15223-2:2010 is to ensure that symbols included in ISO 15223-1 are readily understood by the target group. If the symbol validation process detailed in ISO 15223-2:2010 has been complied with, then ...

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  • Unique Device Identification (UDI) Requirements,

    2021-6-18 · UDI Requirements, Deadlines, Secure Labeling acc. to FDA and MDR. Implementing UDI concerns almost every medical device manufacturer. In the USA, the FDA (Food and Drug Administration) directive is already in force. For Europe, a similar system is underway. Be prepared to comply with the respective programs!

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  • Medtronic hiring Regulatory Affairs Specialist -

    2021-5-26 · We are currently looking for a responsible for Regulatory Affairs in Slovenia. In this position you will ensure that all regulatory and quality requirements necessary to obtain timely regulatory approvals (e.g commercial medical devices) within country are met and quality questions for any Medtronic distributed product and properly addressed.

    Get Price
  • eIFU Header Menu - Johnson & Johnson Medical

    The Medical Devices Business Services, Inc. eIFU website provides you with Instructions for Use (IFU) and other related information for various products from Johnson & Johnson Family of Medical Device Companies. This website is intended for Healthcare Professionals only.

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  • Identifying product requirements - Your Europe

    2021-3-26 · EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process; EU-wide standards and technical specifications exist for a number of product categories. You must ensure your products comply with any relevant EU rules before they can be traded freely in the EU.

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  • Understanding Medical Device Labeling Regulations

    As medical technology advances to a point where the average human lifespan increases, it produces a world in which medical devices are more widely seen in the world. This has brought into focus the need for clear and accurate labeling on medical devices for safe use and user information.

    Get Price
  • List of European Authorised Representative

    2020-12-8 · e. inspection of labeling and symbols regular updates to customers regarding regulatory changes. Product Categories. Medical devices; In-vitro medical devices; Company Information. Year of Registration: 1998; Locations: The Netherlands, United Kingdom, China, United States,

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  • Slovenia - Medical Equipment

    2020-7-22 · As a result of limited and/or highly specialized domestic production, Slovenia’s health care equipment market is dependent on imports from Germany, Italy, Austria, Switzerland, and the United States. U.S. exporters account for between 15 and 20 percent of Slovenia’s USD 450 million medical equipment market.

    Get Price
  • Identifying product requirements - Your Europe

    2021-3-26 · EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process; EU-wide standards and technical specifications exist for a number of product categories. You must ensure your products comply with any relevant EU rules before they can be traded freely in the EU.

    Get Price
  • MedTech Europe, from diagnosis to cure - Homepage

    SLOVENIA Slovenian Labels and IFU must be in Slovenian. Slovenian IFU for self-testing IVD devices is mandatory Professional medical staff devices IFU may be in Slovenian or English. SPAIN Spanish Requires submittance of labeling test to Competent Authorities.

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  • export.gov

    MedTech Europe is the European trade association representing the medical technology industries, from diagnosis to cure. We represent Diagnostics and Medical Devices manufacturers operating in Europe. There are more than 500,000 products, services and solutions currently made available by the medical technology industry.

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  • Labeling 60601 3rd Edition - forum.aliqtisadi.com

    2021-6-17 · Agency for Drugs and Medical Devices, Ptujska 21, 1000 Ljubljana, Slovenia E-mail: [email protected] National Institute of Public Health, Trubarjeva 2, 1000 Ljubljana, Slovenia E-mail: [email protected] Chamber of Commerce and Industry of Slovenia, Dimiceva 13, 1504 Ljubljana, Slovenia E-mail: [email protected] U.S. Commercial Service

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  • Medical Device Labeling Market 2028 By Label Type ...

    2021-6-5 · Medical Devices, Medical Equipment and Diagnostic ProductsThe Vertical File and Its Satellites Page 1/12. Download Free Labeling 60601 3rd Edition ... advertising, labeling, and packaging, it explains the relevant laws, regulations, and requirements in major markets worldwide and provides examples of compliance

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  • The New Regulations for Medical Devices in the EU

    Medical Device Labeling Market Research is expecting to accrue strong growth in forecasts frame, drive By Label Type, Material, Application.

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  • FDA to Amend Labeling Requirements for Medical

    On June 15, 2016, the Food and Drug Administration (FDA) published a final rule, 81 FR 38911, Use of Symbols in Labeling. The final rule revises FDA labeling requirements of medical devices and certain biological products concerning the inclusion of symbols or graphical representations of information. Read the full update here.

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  • MedTech Europe, from diagnosis to cure - Homepage

    MedTech Europe is the European trade association representing the medical technology industries, from diagnosis to cure. We represent Diagnostics and Medical Devices manufacturers operating in Europe. There are more than 500,000 products, services and solutions currently made available by the medical technology industry.

    Get Price
  • Slovenia - E-Commerce | export.gov

    2021-6-2 · Slovenia - E-CommerceSlovenia - eCommerce Describes how widely e-Commerce is used, the primary sectors that sell through e-commerce, and how much product/service in each sector is sold through e-commerce versus brick-and-mortar retail. Includes what a company needs to know to take advantage of e-commerce in the local market and , reputable ...

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  • ISO 15223-2 - European Standards

    ISO 15223-2. ISO 15223-2:2010 specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1. The purpose of ISO 15223-2:2010 is to ensure that symbols included in ISO 15223-1 are readily understood by the target group. If the symbol validation process detailed in ISO 15223-2:2010 has been complied with, then ...

    Get Price
  • Labeling 60601 3rd Edition - forum.aliqtisadi.com

    2021-6-5 · Medical Devices, Medical Equipment and Diagnostic ProductsThe Vertical File and Its Satellites Page 1/12. Download Free Labeling 60601 3rd Edition ... advertising, labeling, and packaging, it explains the relevant laws, regulations, and requirements in major markets worldwide and provides examples of compliance

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  • Wright Medical Group

    2020-3-18 · Wright Medical Group N.V. is a global medical device company focused on Extremities and Biologics. We deliver innovative, value-added solutions improving quality of life for patients worldwide. We are a recognized leader of surgical solutions for the upper extremities (shoulder, elbow, wrist and hand), lower extremities (foot and ankle) and ...

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  • Medical Device Labeling Market 2028 By Label Type ...

    Medical Device Labeling Market Research is expecting to accrue strong growth in forecasts frame, drive By Label Type, Material, Application.

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  • US FDA Shelves Proposal To Mandate Home-Use

    A controversial 2016 proposed rule that would have required manufacturers of many class II and class III home-use devices to electronically submit device labeling information to US FDA will not be finalized, the agency affirmed in the Oct. 17 HHS Unified Agenda document. The agency also signaled plans to imminently finalize a broad device classification rule, and other updates.

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  • PharmaBoardroom | Marketing, Manufacturing,

    2018-8-29 · Legal info on marketing, manufacturing, packaging & labelling in Ecuadorian pharma. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for GBP 75. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other ...

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  • Company A-Z - Verdict Medical Devices

    Flex Circuit Design, Rigid Flex Circuits and Flexible Circuits. FOBA ALLTEC GmbH. Manufacturer of Laser Marking and Engraving Machines for the Medical Device Industry. Formacoat. Hydrophilic and Hydrophobic Coating for Medical Devices. Früh Verpackungstechnik. Contract Packaging for Medical Devices. Frankfurt Laser Company.

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