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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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...

November 1, 2019

Beginning of August, SFDA announced that the new system will replace the current MDMA system and more technical files will be required from the manufacturers to provide evidence of compliance to a certain route. Click here for the new regulations (MDS-G5). The new syst...

November 1, 2019

As of 1 January 2018, non-corrective contact lens will be regulated as medical devices by the Medical Device Authority (MDA). According to the Medical Device (Declaration) Order 2017, “non-corrective contact lens” is contact lens which is not used to correct, remedy or...

November 1, 2019

MDA announced the training for competency module (regulatory requirements) for biomedical technical personnel.

The module is designed to provide participants with the knowledge on medical device regulatory requirements in Malaysia. Biomedical technical personnel, superv...

August 30, 2019

  • Australia: 2019 fees and charges released by the Therapeutic Goods Administration

  • Australia: Conformity assessment standards for medical device QMSs

  • Australia: TGA will no longer send out annual report reminders

  • Australia: Guidance issued on addressi...

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

  • Canada: New fees and performance standards for medical devices effective 1 April 2020

  • Canada: New medical device incident reporting requirements for hospitals

  • Canada: Post-market surveillance requirements proposed for adoption

  • Canada: Guidance on pre...

August 30, 2019

  • Brazil: Parametric release may replace sterility test for ethylene oxide sterilised devices

  • Ecuador: Proposed revision of PRTE INEN No 186 concerning electromedical equipment and systems

  • Mexico: Compulsory standard drafted on Good Manufacturing Practices

    ...

August 30, 2019

  • IMDRF: Guidance drafted on regulatory pathways for personalised medical devices

  • IMDRF: Comments solicited on terminologies for categorised adverse event reporting

  • ISO: Clinical performance studies for IVDs addressed in new ISO standard

    ...

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...

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