guide for distributors of medical devices

Frequently Asked Questions (FAQ) – EU MDR

As a medical device distributor your company is responsible for its own interpretations of the regulation As you point out according to Article 16 paragraph 2 there are activities which "shall not be considered to be a modification of a device" and in 2 (a) "provision of the information supplied by the manufacturer" is given as one such an example Nevertheless while Article

Guide for Distributors of Medical Devices

Guide for Distributors of Medical Devices IA-G0004-1 3/29 1 SCOPE The purpose of this document is to provide guidance to industry on distribution of medical devices in vitro diagnostic medical devices and their accessories for human use in Ireland For the purpose of this document all such medical devices are referred to collectively as

FAQ Guide: Brexit impacts? Need EU and/or UK

Depending on different Brexit scenarios Brexit may have the following imparts on CE marking and medical devices (MD/IVD) placed on the markets of the EU27/EEA and of the UK: 1 Brexit impacts on EU Authorised Represenatives based in EU27 countires for non-EU manufacturers who place CE-marked product on the market of the UK

Medical device distributors

However most medical device distributors will expect credit terms because in some countries their customers may not pay them for anything up to two years Payment terms are an area for negotiation but remember until the money is in your bank account you are just a charity Try to check how good a payer your potential distributor is

MHRA Publishes Guidance Relating to DEHP Phthalates

On 10 September 2015 the Medicines and Healthcare Products Regulatory Agency (MHRA) published guidance in relation to medical devices which contain polyvinyl chloride (PVC) plastic with Di(2-ethylhexyl) phthalate (hereafter DEHP phthalates) The MHRA guidance would appear to be inspired by the publication of a report issued on 25 June 2015 by the European Commission which provides

The top 10 medical device companies (2019)

Worldwide medical device sales increased by 1 5% and the primary contributors included high sales in the following areas: surgical vision wound closure biosurgery and electrophysiology Medtronic $29 9 billion Medtronic is the top medical device company in the world for 2019 with an impressive annual revenue nearly $30 billion in 2018 The company experienced 1% increase in revenue

Training of Medical Device distributors

Training of Medical Device distributors – a grey area ONE of the many questions we are asked when we run our courses is: What are the regulations around product competency when medical device companies sell through a distribution firm? Well the answer is that it's a bit of a grey area However as is frequently the case with medical

Guide to Incident Reporting for General Medical Devices

System for Medical Devices This guide focuses on the area of incidents defining what incidents are and outlines the different roles and responsibilities which users distributors and manufacturers have in the handling of such incidents The IMB is also the Competent Authority (CA) for in-vitro diagnostic medical devices However this guide does not cover the area of in-vitro diagnostic

Medical Devices for Minimally Invasive Procedures

Cook Medical and Surmodics agreement provides options for patients suffering from critical limb isch View Post April 30 2020 Cook Medical's preparedness for COVID-19 View Post January 29 2020 Cook Medical and Bentley announce collaboration View Post January 21 2020 Cook Medical awarded new contract with Veterans Affairs for endovascular medical devices View Post January

Guide for Distributors of Medical Devices

The guide recommends that all distributors of medical devices have a quality system in place and that standard operating procedures are put in place by distributors This guide is a must read for all distributors of medical devices and our Regulatory team is on hand to provide advice in respect of the New Regulations

The HPRA published a MDR/IVDR Guide for Distributors of

The Guide addresses and clarifies the obligations which will be applicable to distributors of medical devices under the MDR and the IVDR The document also includes some important recommendations concerning the methods that can be used by distributors to comply with their obligations and ensure good distribution practices

Irish competent authority publishes guide for distributors

Irish competent authority publishes guide for distributors of medical devices The document aims to provide supplementary guidance and recommendations for best practices to distributors acting in Ireland taking into account the obligations for medical device including in vitro diagnostic medical device distributors in the IVD and MD Regulations

5 Largest Medical Supply Distributors

Here are five of the largest medical supply distributors that you'll definitely want to know if you're looking for ways to support your office clinic or healthcare facility stay on top of your inventory and keep your medical supply inventory stocked for your staff: McKesson With over $214 billion in annual revenue the Texas-based McKesson Corporation is the wholesale medical supply

Danish wholesale distributors of medicine have infringed

The two distributors have restricted competition by agreeing a joint set of rules to all medicine manufacturers on the Danish market The rules entered into force in January 2002 and concern among other things the prices for the handling of returned goods from the pharmacies The Danish Competition and Consumer Authority obtained knowledge of the anti-competitive agreement after having

Guide to Incident Reporting for General Medical Devices

MEDICAL DEVICES AND ACTIVE IMPLANTABLE MEDICAL DEVICES SUR-G0003-3 06 APRIL 2010 This guide does not purport to be an interpretation of the law and/or regulations and is for guidance purposes only IMB Guide to Incident Reporting for General Medical Devices and Active Implantable Medical Devices _____ SUR-G0003-3 CONTENTS 1 SCOPE 1 2 INTRODUCTION 1 3

UDI guidance: Unique Device Identification (UDI) of

The IMDRF Guidance on a Unique Device Identification (UDI) System for Medical Devices clarifies and supplements the above mentioned GHTF Guidance by providing nonbinding rules - for use in the regulation of medical devices and has been subject to consultation throughout its development There are no restrictions on the reproduction distribution or use of this document however

Medical devices

On 07 December 2017 the Royal Decree (RD) concerning the notification of a materovigilance point of contact and the registration of medical device distributors and exporters has been published This RD will apply 10 days after this publication 17 December 2017 This legal text describes repealing and amending provisions of the legislation currently applicable to your domain of activity

ISO 13485:2016

Medical devices ? A practical guide has been authored by technical experts of ISO/TC 210 The handbook is intended to guide organizations in the development implementation and maintenance of their quality management system in accordance with ISO 13485 Organizations active in the medical device sector such as manufacturers importers distributors service providers certification bodies


According to the European Directives applicable to medical devices and medical devices for in vitro diagnostic a manufacturer is defined as the natural or legal person with responsibility for the design manufacture packaging and labelling of a device before it is placed on the market under his own name regardless of whether these operations are carried out by that person himself or on his

Good Distribution Practices (GDP) and similiar for

08 07 2013WHO's GDP guidance Although medical devices are not included in the definition of pharmaceutical products for the purposes of this document the main principles established in this document may also be used where applicable for medical devices is there any other country/agencies that already have or is going to have GDP or other medical device distribution

Healthcare Resource Guide: Honduras

Imports of medical equipment and devices have been steadily increasing amounting to an estimated $36 million in 2018 In 2018 imports of pharmaceutical products totaled an estimated $505 million up 4 percent from imports in 2017 Honduras has the fourth largest pharmaceutical market in Central America Honduras' economic performance continues to be moderately favorable with an estimated

MHRA's guide to the new EU Medical Devices

MHRA Medical devices: EU regulations for MDR and IVDR: Placing a device on the market under the new Regulations Definitions : as well as setting out the definitions of devices and in vitro diagnostic devices the Interactive Guide provides guidance on borderline products and aesthetic products such as non-corrective contact lenses and dermal fillers which are covered by the Regulations for

China Medical Device Registration

The China Food Drug Administration (CFDA) is responsible for medical devices drugs and healthcare services The organization is headquartered in Beijing with offices in each province The Center for Medical Device Evaluation (CMDE) is responsible for conducting the dossier review during the medical device registration process The General Administration of Quality Supervision Inspection

An Overview of FDA Regulations for Medical Devices

An Overview of FDA Regulations for Medical Devices For developing medical devices in the USA manufacturers and distributors must have a complete understanding the regulations and compliances This blog provides a detailed overview of the FDA regulations for medical devices

Guidance for Procurement in Medical Devices ISO

Guidance for Procurement in Medical Devices ISO 13485 Identifying suppliers in the medical device industry is not always as simple as going on the internet and searching keywords As part of an ISO 13485 compliant Quality Management System (QMS) purchasing controls must be established to ensure that quality raw materials are going into your device and that all services directly and/or

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