China

Aug 72 min read

China: NIFDC Announces New Technical Guidelines for Cosmetic Stability, Preservative Challenge, and Packaging Compatibility Testing and Evaluation

The National Institutes for Food and Drug Control (NIFDC) formulated three new technical documents to facilitate the industry in cosmetic...

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China: NMPA Outlines New Standards for Radiofrequency Therapy Devices (w.e.f 1 April 2026)

ARQon

Jul 161 min read

China: NMPA Outlines New Standards for Radiofrequency Therapy Devices (w.e.f 1 April 2026)

On the 2nd of July 2024, the Centre for Medical Device Evaluation (CMDE) announced the clarification by the National Medical Products...

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China: Optimization of Registration Application for Transferring Overseas-Produced Drugs into Domestic Production

ARQon

May 281 min read

China: Optimization of Registration Application for Transferring Overseas-Produced Drugs into Domestic Production

As part of the initiative to boost foreign investments in the pharmaceutical industry and improve high-quality drug developments and...

10 views0 comments

ARQon

Jan 7, 20201 min read

China Clinical Requirements Update

China Clinical Requirements Update On 13th December, the CMDE published the Public Consultation (Deadline: 13 Jan 2020) on “Technical...

60 views0 comments

ARQon

Dec 4, 20192 min read

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...

102 views0 comments

ARQon

Aug 30, 20191 min read

Asia, Africa & Middle East - Aug 2019

Australia: 2019 fees and charges released by the Therapeutic Goods Administration Australia: Conformity assessment standards for medical...

119 views0 comments

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, 20192 min read

Asia, Africa & Middle East - Jun 2019

Australia: Proposed reclassification of spinal implantable medical devices Australia: Proposed regulatory scheme for personalised medical...

88 views0 comments

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...

25 views0 comments

ARQon

Jun 28, 20192 min read

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...

175 views0 comments

ARQon

Jun 28, 20192 min read

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, 20191 min read

Asia, Africa & Middle East - Mar 2019

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

92 views0 comments

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...

21 views0 comments

ARQon

Mar 28, 20191 min read

China NMPA Innovation Pathway Document List

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

160 views0 comments

ARQon

Mar 28, 20191 min read

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...

63 views0 comments

ARQon

Nov 14, 20184 min read

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...

60 views0 comments

ARQon

Nov 5, 20181 min read

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...

17 views0 comments

ARQon

Nov 5, 20181 min read

Drug - Dec 2018

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

23 views0 comments

China's NMPA expands Clinical Trial Exemption List for Medical Devices & IVDs

ARQon

Oct 18, 20181 min read

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...

249 views0 comments

ARQon

Sep 4, 20182 min read

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...

74 views0 comments

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