e-Registration Submission System NMPA plans to publicise the usage of its electronic Regulated Product Submission (eRPS) system. The eRPS...

Medical Device Regulations China's National Medical Products Administration (NMPA) have published the following registration guidelines...

Australia: Reclassification of surgical mesh devices and publication of associated guidance Australia: Proposed fees and charges for...

Australia - Procedure for Priority Review / Accelerated Approval China - NMPA Announcement 2019/10: Adjusting Classification of 12 Types...

In December 2018, China's National Medical Products Administration (NMPA) released the Special Medical Device Special Review Procedure...

Executive Summary: The January 2019 Asian Medtech Associations Regulatory Networking discussions focus on the volume of activity within...

Draft on Local Representatives' Obligations In order to ensure the safety and effectiveness of imported medical devices, NMPA has...

AHWP: Guidance on labelling for in vitro diagnostic medical devices Australia: Application fee change for export only medical devices...

Australia - Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2018 Brazil - Questions and Answers: Resolution RDC...

In September 2018, China's National Medical Products Administration (NMPA) released two expanded lists - Medical devices & IVDs that are...

Australia: 2018 fees and charges released by the Therapeutic Goods Administration Australia: Application fee now charged for a Class I...

International - ICH Guidelines Implementation Australia - Medical Devices Safety Update, Volume 6, Number 4, Jul-2018 China - CDE...

Australia: Changes to the therapeutic goods advertising framework Australia: Guidance on updating an existing Class 1–3 in-house IVD...

Australia: ‘Therapeutic Goods (Manufacturing Principles) Determination 2018’ Australia: Implementation of new Uniform Recall Procedure...

Australia: Articles that alter the pH of body fluids are not medical devices Australia: Up-classification of surgical mesh and provision...

Executive Summary: China is Making Additions to its medtech regulatory system, and Southeast Asian nations are making progress towards...

Australia: Therapeutic Goods Amendment (2016 Measures No 1) Bill 2016 Australia: Consultation held on future regulation of low risk...

Australia: Guidelines on Compounded Medicines and Good Manufacturing Practice (GMP) Australia: Guidelines on Code of Practice for...

Asia: Raft of guidance documents endorsed at 21st Annual Meeting of the AHWP Australia: Regulatory reform consultations Australia: MTAA...

Australia: Strengthening Monitoring of Medicines in Australia Canada: Notice: Guidance Document - Fees for the Right to Sell Drugs...