- Jan 7, 2020
China Clinical Requirements Update
China Clinical Requirements Update On 13th December, the CMDE published the Public Consultation (Deadline: 13 Jan 2020) on “Technical...
- Dec 4, 2019
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...
- Aug 30, 2019
Asia, Africa & Middle East - Aug 2019
Australia: 2019 fees and charges released by the Therapeutic Goods Administration Australia: Conformity assessment standards for medical...
- Aug 30, 2019
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...
- Jun 28, 2019
Asia, Africa & Middle East - Jun 2019
Australia: Proposed reclassification of spinal implantable medical devices Australia: Proposed regulatory scheme for personalised medical...
- Jun 28, 2019
Drugs - Jun 2019
China - CFDA Announcement No. 2017/187: Announcement on Cancellation of Drug Protection Fees, Certification Fees, Import / Export...
- Jun 28, 2019
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...
- Jun 28, 2019
Healthcare Regulatory Reforms in China
Medical Device Regulations China's National Medical Products Administration (NMPA) have published the following registration guidelines...
- Mar 29, 2019
Asia, Africa & Middle East - Mar 2019
Australia: Reclassification of surgical mesh devices and publication of associated guidance Australia: Proposed fees and charges for...
- Mar 29, 2019
Drugs - Mar 2019
Australia - Procedure for Priority Review / Accelerated Approval China - NMPA Announcement 2019/10: Adjusting Classification of 12 Types...