China Clinical Requirements Update
China Clinical Requirements Update On 13th December, the CMDE published the Public Consultation (Deadline: 13 Jan 2020) on “Technical...
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ARQon
- Dec 4, 2019
- 2 min
Asia, Africa & Middle East - Nov/Dec 2019
Australia: Proposed changes to the Essential Principles for safety and performance Australia: Proposed changes to the requirements for...
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ARQon
- Aug 30, 2019
- 1 min
Asia, Africa & Middle East - Aug 2019
Australia: 2019 fees and charges released by the Therapeutic Goods Administration Australia: Conformity assessment standards for medical...
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ARQon
- Aug 30, 2019
- 1 min
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, 2019
- 2 min
Asia, Africa & Middle East - Jun 2019
Australia: Proposed reclassification of spinal implantable medical devices Australia: Proposed regulatory scheme for personalised medical...
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ARQon
- Jun 28, 2019
- 1 min
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
- Jun 28, 2019
- 2 min
China NMPA: e-Registration, Product lifetime, Inspection and Testing Institutions
e-Registration Submission System NMPA plans to publicise the usage of its electronic Regulated Product Submission (eRPS) system. The eRPS...
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ARQon
- Jun 28, 2019
- 2 min
Healthcare Regulatory Reforms in China
Medical Device Regulations China's National Medical Products Administration (NMPA) have published the following registration guidelines...
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ARQon
- Mar 29, 2019
- 1 min
Asia, Africa & Middle East - Mar 2019
Australia: Reclassification of surgical mesh devices and publication of associated guidance Australia: Proposed fees and charges for...
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ARQon
- Mar 29, 2019
- 1 min
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 28, 2019
- 1 min
China NMPA Innovation Pathway Document List
In December 2018, China's National Medical Products Administration (NMPA) released the Special Medical Device Special Review Procedure...
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ARQon
- Mar 28, 2019
- 1 min
China Issues Raft of Regulatory Notices: Guidelines, Standards and More Reforms
Executive Summary: The January 2019 Asian Medtech Associations Regulatory Networking discussions focus on the volume of activity within...
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ARQon
- Nov 14, 2018
- 4 min
China Releases Document on Local Representatives' obligations and bolsters Adverse Event Reporti
Draft on Local Representatives' Obligations In order to ensure the safety and effectiveness of imported medical devices, NMPA has...
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ARQon
- Nov 5, 2018
- 1 min
Asia, Africa & Middle East - Dec 2018
AHWP: Guidance on labelling for in vitro diagnostic medical devices Australia: Application fee change for export only medical devices...
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ARQon
- Nov 5, 2018
- 1 min
Drug - Dec 2018
Australia - Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2018 Brazil - Questions and Answers: Resolution RDC...
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ARQon
- Oct 18, 2018
- 1 min
China's NMPA expands Clinical Trial Exemption List for Medical Devices & IVDs
In September 2018, China's National Medical Products Administration (NMPA) released two expanded lists - Medical devices & IVDs that are...
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ARQon
- Sep 4, 2018
- 2 min
Asia, Africa & Middle East - Aug/Sep 2018
Australia: 2018 fees and charges released by the Therapeutic Goods Administration Australia: Application fee now charged for a Class I...
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ARQon
- Sep 4, 2018
- 1 min
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, 2018
- 2 min
Asia, Africa & Middle East - May 2018
Australia: Changes to the therapeutic goods advertising framework Australia: Guidance on updating an existing Class 1–3 in-house IVD...
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ARQon
- Feb 2, 2018
- 2 min
Asia, Africa & Middle East - February 2018
Australia: ‘Therapeutic Goods (Manufacturing Principles) Determination 2018’ Australia: Implementation of new Uniform Recall Procedure...
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