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

  • Brazil: Requirements finalised for custom-made and patient-specific medical devices

  • Brazil: Proposed changes to requirements for syringes and infusion/transfusion pump sets

  • Ecuador: Technical Regulations on condoms, operating tables and surgical gloves

  • ...

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

    ...

November 5, 2018

  • Brazil: Requirements drafted for custom-made and patient-specific medical devices

  • Brazil: Procedure for handling imported medical devices with different terms of validity

  • Chile: Natural rubber latex male condoms, male synthetic condoms and female condoms...

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