REGULATORY NEWS & UPDATES

The ARQon Gazette News

      Global Regulatory & Quality Bulletin 
The ARQon Gazette is a compilation of latest updates in the medical device and drug industry. These updates might have an impact to manufacturers and other industry participants.
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December 4, 2019

  • EU: Commission Implementing Decision (EU) 2019/1396 on the designation of expert panels

  • EU: Industry expresses concerns about proposed Common Specifications for the reprocessing of single-use medical devices

  • EU: Proposal to update the Common Technical Spe...

November 7, 2019

It was confirmed by the European Commission on 30 October 2019 that the Medical Device Regulation (MDR) EUDAMED will be delayed for two years which will launch in May 2022.

The Commission is working on the implementation on the latest EUDAMED database which will improve...

August 30, 2019

  • Albania: Amendments proposed to ‘Law on Medical Devices’

  • EU: New MDCG documents on Notified Bodies, the person responsible for regulatory compliance, and implant cards

  • EU: Supplementary guidance released on the Medical Device Vigilance System

  • EU: Gra...

August 30, 2019

  • China : NMPA No. 2019/34 Issuance of Provision n Drug Quality Inspection and and Testing

  • EU/US : EMA/FDA Analysis Shows High Degree of Alignment in Marketing Application Decisions Between EU and US.

  • South Korea :  Five-year Master Plan for Clinical T...

June 28, 2019

Background: The MDR will replace the existing Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD).

The transitional period will end on 26 May 2020, the “Date of Application” (DoA) of the Regulation. To av...

June 28, 2019

Background: The IVDR will replace the existing In Vitro Diagnostic Medical Devices Directive (98/79/EC) (IVDD). The transitional period will end on 26 May 2022, the “Date of Application” (DoA) of the Regulation. To avoid market disruption and allow a smooth transition...

June 28, 2019

  • Czech Republic: Form released for accessing online reimbursement system

  • EU: Corrigenda published to Regulations 2017/745 and 2017/746

  • EU: MDCG clarifies scope of clinical evaluation consultation procedure

  • EU: EMA issues Q&A document to assist with im...

June 28, 2019

  • China - CFDA Announcement No. 2017/187: Announcement on Cancellation of Drug Protection Fees, Certification Fees, Import / Export Licences Fees of Narcotic and Psychotropic Drugs

  • Philippines - FDA Circular No. 2012-007-A: Amending FDA Circular No. 2012-007: Re...

June 28, 2019

Executive Summary:

This month's Asian Medtech Associations Regulatory Networking discussions is split into two parts, the first being a guest presentation on EU themes, specifically a UK Brexit outlook and an update on the progress of the EU IVDR, which comes into full...

June 28, 2019

NB Listed in European Commission’s New Approach Notified and Designated Organisations (NANDO)

To date, two Notified Bodies have been designated under the EU Medical Device Regulation (MDR), which will be effective from May 2020

It was expected that another 20 Notified Bo...

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