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

  • Australia: Proposed changes to the Essential Principles for safety and performance

  • Australia: Proposed changes to the requirements for systems and procedure packs

  • Australia: Feedback sought on the regulation of certain self-testing IVDs in Australia

  • ...

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...

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...

January 10, 2019

Taiwan FDA is currently seeking public feedback on three new regulations in cosmetic products.

The Authority proposing draft Regulations for the Inspection and Examination of Imported Cosmetics, including requirements for the methods, techniques, items and scope of samp...

November 5, 2018

  • Australia - Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2018

  • Brazil - Questions and Answers: Resolution RDC 242/2018 on Registration of Specific Medicinal Products

  • Canada - Form: Post-Notice of Compliance Changes: Level III

  • Chin...

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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