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China: Regulatory Adjustments for Imported Medical Devices in China
The recent adjustment to the “Announcement of the State Drug Administration on Matters Related to the Production of Imported Medical...

ARQon
Mar 262 min read


China: Enhanced Regulations for Cosmetic Ingredients Innovation
Effective on the issuance date, 26 January 2025, the National Medical Products Administration (NMPA) has started implementing “Several...

ARQon
Mar 123 min read


China: New Wire Assembly Standards (w.e.f. 1 October 2025)
The National Certification and Accreditation Administration (CNCA) recently announced changes to the national standards for wire...

ARQon
Feb 242 min read


China: New Updates for Pharmaceutical Excipients and Packaging Materials Appendices to GMP (w.e.f. 1 January 2026)
The State Drug Administration of China has released an important update aimed at strengthening the quality management of pharmaceutical...

ARQon
Jan 82 min read


China: NMPA Introduces Interim Provisions on Domestic Responsible Persons Designated by Overseas Drug Marketing Authorization Holders (w.e.f 1 July 2025)
To enforce the Drug Administration Law of the People’s Republic of China and the Vaccine Administration Law of the People’s Republic of...

ARQon
Dec 10, 20242 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...

ARQon
Aug 7, 20242 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...

ARQon
Jul 16, 20241 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...

ARQon
May 28, 20241 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...

ARQon
Jan 7, 20201 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...

ARQon
Dec 4, 20192 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...

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...

ARQon
Aug 30, 20191 min read
Asia, Africa & Middle East - Jun 2019
Australia: Proposed reclassification of spinal implantable medical devices Australia: Proposed regulatory scheme for personalised medical...

ARQon
Jun 28, 20192 min read
Drugs - Jun 2019
China - CFDA Announcement No. 2017/187: Announcement on Cancellation of Drug Protection Fees, Certification Fees, Import / Export...

ARQon
Jun 28, 20191 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...

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...

ARQon
Jun 28, 20192 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...

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...

ARQon
Mar 29, 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...

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...

ARQon
Mar 28, 20191 min read
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