medical device guidance

New FDA Draft Guidance Helps Define the Scope of 510(k

This guidance when finalized will aid manufacturers of medical devices subject to premarket notification requirements who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (also referred to together as "existing devices") during the process of deciding whether the modification exceeds the regulatory threshold of 21 C F R 807 81(a)(3) for submission


This Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737) and the regulations under it This Guidance Document shall be read in conjunction with the current laws and regulations used in Malaysia which include but not limited to the following- a) Medical Device Act 2

Medical Device Regulatory Services

Helping you navigate the often complicated path to compliance our medical device regulatory experts provide you the guidance you need to market medical devices in countries around the world We leverage our certification and technical expertise to give you confidence in both your products and the compliance process

Medical Device Regulation MDR

As of May 25th 2017 the Medical Device Regulation MDR and In-vitro Medical Device Regulation IVDR entered into force These regulations replace the EU directives (MDD IVDD and AIMD) As of May 26th 2020 the MDR shall apply on May 26th 2022 the IVDR

FDA Guidance for Software

Medical Device and Software Software-Related FDA Guidance Documents A representative list of documents/information pertaining to medical device software which should be useful for your consideration use and/or implementation for regulatory purposes March 11 1997: FDA Design Control Guidance on Medical Device Manufacturers

Guideline for Registration of Medical devices 2014 – EFDA

The method of classification for medical devices other than IVD medical devices stated in this Guideline depends on the intended use of the device indications for use duration of use degree of invasiveness and local vs systemic effect of the device The method of classification for IVD medical devices is based on individual vs public health risk and on the intended use of the device

Regulations and Guidance

Regulations and Guidance FDA NHS eProcurement Scan4Safety EUMDR AND Others The FDA was the first entity to require product data in a public database At first many manufacturers used spreadsheets to push information to the GUDID As more regulators and organizations require electronic product data Smiths Medical has expanded our system to accommodate machine-to-machine data

FDA Publishes Final Guidance on Medical Device

The guidance supersedes the 2013 draft guidance as well as the 1997 manufacturer MDR guidance document There have been numerous changes to the medical device reporting requirements since the FDC Act first described them and the Medical Device Reporting regulation became effective over 20 years ago The FDA's final guidance on medical

Prepare your medical device software for the new FDA

As the FDA adds more cybersecurity requirements in their new software validation guidance medical device manufacturers can turn to static analysis the most effective method to address safety and security concerns and deliver predictable software As I mentioned in a blog post a few weeks ago this year at Embedded World we enjoyed significantly more conversations with medical devices

Guidance documents

Guidance documents have been prepared to assist in the interpretation of policies and governing statutes and regulations They are intended to assist in preparing the various device licence applications required when seeking an authorization to sell a medical device product in Canada

Regulatory Guidance for Medical Devices

Medical Devices Regulatory Guidance Importing Medical Devices into New Zealand Obligations for medical device importers More Contraceptive Devices Information on standards for contraceptive devices More In-Vitro Diagnostic (IVD) Devices Definitions and exemptions More Labelling of Medical Devices and Instructions for Use (IFU) Labelling requirements and guidelines Instructions

FDA Issues Draft Guidance on Medical Device Safety in

FDA Issues Draft Guidance on Medical Device Safety in MRI Environment Draft guidance document available for public comment for 60 days provides suggested standards for testing and labeling of medical devices meant to function in an MRI environment August 1 2019 — The U S Food and Drug Administration (FDA) issued a new draft guidance titled Testing and Labeling Medical Devices for

medical device forum 2020

Medical Device Regulation: Aktueller Stand der Implementierung Konsequenzen fr die Hersteller/Wirtschaftsakteure Status von Implementierungsprojekten „MDCG Guidances Gemeinsame Spezifikationen Implementing Acts Medizinprodukte-EU-Anpassungsgesetz – MPEUAnpG# Medizinprodukte-Durchfhrungsgesetz (MPDG) Dr Matthias Neumann

Health Canada Guidance for Medical Device Cybersecurity

The Health Canada guidance document for pre‐market requirements for medical device cybersecurity encourages manufacturers to secure all connections between other devices and interfaces This will ensure best practice for secure authentication when connecting to back-end systems like servers and electronic health record systems The guidance also includes securing connections between devices

An Introduction To International Medical Device Standards

pOne common source of misunderstanding in the medical device industry is the method the various national regulatory systems use to identify standards This article explains the method starting with standards from the International Organization for Standardization (ISO) adopted and recognized in various regulatory systems The article uses ISO 13485:2003 and ISO 14971:2007 as illustrations /p

FDA Issues Guidance On New Medical Device Shortage

The Guidance is intended to facilitate timely disclosures to FDA and help the Agency prevent or mitigate any potential medical device shortages during the COVID-19 health emergency The Guidance clarifies and makes recommendations regarding three major notification requirements: (1) who must notify FDA (2) when to notify FDA and (3) what information to include in notifications

Understanding the Benefit

Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents by Medical Device Podcast published on 2019-09-23T13:33:38Z If you haven't realized it yet risk management in the medical device industry isn't going away How do you navigate capture and document when and what to do? In this episode Jon Speer invites guest Mike Drues of Vascular Sciences to join the show

FDA Releases Final Post

The Post-Market Guidance entitled Postmarket Management of Cybersecurity in Medical Devices provides a proactive and risk-based approach that medical device manufacturers and health care systems can utilize to maintain medical device security The Post-Market Guidance outlines what the FDA considers "good cyber hygiene" practices and reinforces the FDA's earlier public positions on

Premarket Assessment of Pediatric Medical Devices

medical device in a pediatric population as defined above in which there is a primary pediatric indication General indications where considerable pediatric application is anticipated are also included in this definition V General Principles in Medical Device Evaluation -----and -----of Guidance Medical


The European Commission provides a range of guidance documents to assist sTongWeiholders in implementing the medical devices regulations Legally non-binding guidance documents adopted by the medical device coordination group (MDCG) in accordance with Article 105 of Regulation 745/2017 pursue the objective of ensuring uniform application of the relevant provisions of the regulations within

FDA Guidance for Software

Medical Device and Software Software-Related FDA Guidance Documents A representative list of documents/information pertaining to medical device software which should be useful for your consideration use and/or implementation for regulatory purposes March 11 1997: FDA Design Control Guidance on Medical Device Manufacturers

MDR Guidance Documents – Medical Device Regulation

Drug-device combinations: Guideline quality requirements drug-device combinations_en-1 pdf: EMA: ART 15 PRRC: MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a 'person responsible for regulatory compliance' (PRRC) EC: MDR Route: MDR Conformity Assessment

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