The Medicines and Healthcare Products Regulatory Agency (MHRA) released new guidance to help manufacturers navigate the UK medical device...

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a final call reminding marketing authorization holders...

EU: Commission Implementing Decision (EU) 2019/1396 on the designation of expert panels EU: Industry expresses concerns about proposed...

China : NMPA No. 2019/34 Issuance of Provision n Drug Quality Inspection and and Testing EU/US : EMA/FDA Analysis Shows High Degree of...

Czech Republic: Form released for accessing online reimbursement system EU: Corrigenda published to Regulations 2017/745 and 2017/746 EU:...

China - CFDA Announcement No. 2017/187: Announcement on Cancellation of Drug Protection Fees, Certification Fees, Import / Export...

EU: More advisory documents issued to support implementation of MDR and IVDR EU: Manual on borderline and classification issues updated...

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

On 26 February, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published further guidance setting out the...

The exit of the United Kingdom (UK) from the European Union (EU) will cause implications to the medical industry in Australia....

EU: UDI guidance documents developed by the MDCG to support implementation of MDR EU: Basic guidance issued for manufacturers on...

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

EU: Manual on borderline and classification issues updated France: Decree on summary of characteristics for Class III/implantable devices...

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

EU/UK: Withdrawal of the UK and EU rules in the field of industrial products EU: Commission proposes Member State cooperation on Health...

EU: Codes and corresponding device types, application forms, and application documentation for Notified Body designation EU: Conditions...

EU: Codes and corresponding device types, application forms, and application documentation drafted for NB designation EU: Products whose...

Europe: European Parliament adopts new medical devices and in vitro diagnostics Regulations Europe: Court of Justice delivers its...

Europe: Latest timings on the new Regulations for medical devices and IVDs Europe: Products whose principal intended action (depending on...

The precise impact of a vote for Brexit is currently still uncertain. It would fundamentally change the nature of the UK’s relationship...