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

    ...

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

  • 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...

May 30, 2019

On March 1st, 2019, ANVISA published RDC 270 / 2019 in the Brazilian Official Gazette. The new legislation deals with the migration of the cadastro route to the notification route for Class I medical devices (materials, equipment and IVD products). RDC 270/2019 amends...

March 29, 2019

  • Australia - Procedure for Priority Review / Accelerated Approval

  • China - NMPA Announcement 2019/10: Adjusting Classification of 12 Types of Drugs

  • South Korea - Procedure for Applying for a Manufacturing / Wholesale Licence

  • Taiwan - MOHW Announcement...

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...

September 4, 2018

  • International - ICH Guidelines Implementation

  • Australia - Medical Devices Safety Update, Volume 6, Number 4, Jul-2018

  • China - CDE Notification on Issuance of the General Requirements for the Production Scales of Generic Drug Registration Batches (Trial)

  • ...

November 1, 2017

  • US: Minimal Manipulation and Homologous Use Products

  • US: Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients

  • US: De Novo Classification Process (Evaluation of Automatic Class III Designation

  • US: Medical Device Develo...

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