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ARQon
Dec 31 min read
United Kingdom: MHRA Urges MAHs to Finalize Windsor Framework Adjustment
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a final call reminding marketing authorization holders...
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ARQon
Dec 4, 20191 min read
Europe - Nov/Dec 2019
EU: Commission Implementing Decision (EU) 2019/1396 on the designation of expert panels EU: Industry expresses concerns about proposed...
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ARQon
Aug 30, 20191 min read
Drugs - Aug 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...
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ARQon
Jun 28, 20191 min read
Europe - Jun 2019
Czech Republic: Form released for accessing online reimbursement system EU: Corrigenda published to Regulations 2017/745 and 2017/746 EU:...
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ARQon
Jun 28, 20191 min read
Drugs - Jun 2019
China - CFDA Announcement No. 2017/187: Announcement on Cancellation of Drug Protection Fees, Certification Fees, Import / Export...
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ARQon
Mar 29, 20191 min read
Europe - Mar 2019
EU: More advisory documents issued to support implementation of MDR and IVDR EU: Manual on borderline and classification issues updated...
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ARQon
Mar 29, 20191 min read
Drugs - Mar 2019
Australia - Procedure for Priority Review / Accelerated Approval China - NMPA Announcement 2019/10: Adjusting Classification of 12 Types...
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ARQon
Mar 29, 20195 min read
UK regulator provides further ‘no deal’ Brexit guidance for medical devices regulation
On 26 February, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published further guidance setting out the...
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ARQon
Mar 28, 20192 min read
Australia TGA Plans for Brexit
The exit of the United Kingdom (UK) from the European Union (EU) will cause implications to the medical industry in Australia....
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ARQon
Nov 5, 20181 min read
Europe - Dec 2018
EU: UDI guidance documents developed by the MDCG to support implementation of MDR EU: Basic guidance issued for manufacturers on...
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ARQon
Nov 5, 20181 min read
Drug - Dec 2018
Australia - Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2018 Brazil - Questions and Answers: Resolution RDC...
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ARQon
Sep 4, 20181 min read
Europe - Aug/Sep 2018
EU: Manual on borderline and classification issues updated France: Decree on summary of characteristics for Class III/implantable devices...
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ARQon
Sep 4, 20181 min read
Drugs - Aug/Sep 2018
International - ICH Guidelines Implementation Australia - Medical Devices Safety Update, Volume 6, Number 4, Jul-2018 China - CDE...
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ARQon
May 23, 20181 min read
Europe - May 2018
EU/UK: Withdrawal of the UK and EU rules in the field of industrial products EU: Commission proposes Member State cooperation on Health...
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ARQon
Feb 2, 20181 min read
Europe - February 2018
EU: Codes and corresponding device types, application forms, and application documentation for Notified Body designation EU: Conditions...
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ARQon
Jan 1, 20181 min read
Europe - December 2017
EU: Codes and corresponding device types, application forms, and application documentation drafted for NB designation EU: Products whose...
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ARQon
Aug 24, 20171 min read
Europe - May 2017
Europe: European Parliament adopts new medical devices and in vitro diagnostics Regulations Europe: Court of Justice delivers its...
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ARQon
Apr 5, 20171 min read
Europe - April 2017
Europe: Latest timings on the new Regulations for medical devices and IVDs Europe: Products whose principal intended action (depending on...
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ARQon
Aug 10, 20162 min read
Brexit: Impact to the UK medical device industry
The precise impact of a vote for Brexit is currently still uncertain. It would fundamentally change the nature of the UK’s relationship...
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