EU: MDCG 2024-1 - DEVICE SPECIFIC VIGILANCE GUIDANCE (DSVG) TEMPLATE – MARCH/APRIL 2024
- 2024-04-08 08:12:16
This guidance aims to harmonize vigilance reporting and provide guidance for manufacturers of Specific Devices.
MoreThis guidance aims to harmonize vigilance reporting and provide guidance for manufacturers of Specific Devices.
MoreLast February 19, 2024, Hong Kong Medical Device Division has published a Supplementary Information Sheet (MD111) to strengthen procurement strategy with the Hospital Authority (HA). HA procured devices seeking to be listed under Medical Device Administrative Control System can provide supplementary information through this form for regulatory authorities’ consideration.
MoreThe Medical Device Authority (MDA) published new Guidance Document, on "MEDICAL DEVICE FOR PERSONAL USE", on January 30, 2024. This document serves as guidance for individuals who intend to bring any medical devices into Malaysia (referred as "import") for the purpose of personal use.
This guidance document specifies the requirements for the importation of personal use medical devices. This document applies to all home use medical devices that fall within the definition of a medical device, as defined in MDA/GD/0006: Definition of Medical Device, including in vitro diagnostic (IVD) medical devices. Not all medical device can fall under the category of personal use medical device.
The Medical Device Authority (MDA) published new Guidance Document, on “POST MARKET INFORMATION EXCHANGE FOR ASEAN MEMBER STATES”, on January, 2024. This document serves as guidance on exchange of post market information among AMS.
In order to maintain patient safety and public health, it is necessary that all medical devices that are placed in the market meet appropriate standards of safety, quality and performance, and that they are used safely.
Last January 25, Qualtech hosted its inaugural webinar for 2024 to discuss matters about updates in the European Medical Device Regulations (MDR) and provide insights into the key elements necessary for a successful regulatory compliance process.
MoreThis guidance clarifies the exemptions from the requirement to perform clinical investigations, and associated conditions related to the demonstration of equivalence, for implantable and class III medical devices
MoreThe Medical Device Authority (MDA) published the Second edition Guidance Document, "Guidance on General Medical Device", on January 30, 2024. This guidance document provides aims to help determine the appropriate grouping for medical devices in the medical device registration application. This document applies to all products that fall within the definition of medical device that has been specified in the Guidance Document: Definition of Medical Device (MDA/GD/0006) excluding In-vitro Diagnostic Medical Device.
MoreThis guidance explains the qualification and classification of products without an intended medical purpose listed in Annex XVI of the MDR.
MoreThis guidance provides demonstration of equivalence for products without an intended medical purpose listed in Annex XVI of the MDR.
MoreJoin us on our upcoming webinar and don't miss this chance to get expert EU MDR insights in the registration of aesthetic-purpose devices. See you on January 25, 2024 at 5 PM Taipei Time (10 AM CET)!
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