The National Certification and Accreditation Administration (CNCA) recently announced changes to the national standards for wire...

The State Drug Administration of China has released an important update aimed at strengthening the quality management of pharmaceutical...

To enforce the Drug Administration Law of the People’s Republic of China and the Vaccine Administration Law of the People’s Republic of...

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

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

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

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

Australia: Proposed changes to the Essential Principles for safety and performance Australia: Proposed changes to the requirements for...

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

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

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

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

e-Registration Submission System NMPA plans to publicise the usage of its electronic Regulated Product Submission (eRPS) system. The eRPS...

Medical Device Regulations China's National Medical Products Administration (NMPA) have published the following registration guidelines...

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

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

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

Executive Summary: The January 2019 Asian Medtech Associations Regulatory Networking discussions focus on the volume of activity within...

Draft on Local Representatives' Obligations In order to ensure the safety and effectiveness of imported medical devices, NMPA has...

AHWP: Guidance on labelling for in vitro diagnostic medical devices Australia: Application fee change for export only medical devices...