The Food and Drug Administration (FDA) has designated an AAMI standard and technical information report (TIR), both published earlier...

Background: The MDR will replace the existing Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Medical Devices...

Background: The IVDR will replace the existing In Vitro Diagnostic Medical Devices Directive (98/79/EC) (IVDD). The transitional period...

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

Czech Republic: Form released for accessing online reimbursement system EU: Corrigenda published to Regulations 2017/745 and 2017/746 EU:...

Canada: Medical device fees increased by 2% from 1 April 2019 Canada: ‘Medical Devices Regulations’ updated to refer to 2016 edition of...

Argentina: Procedure for requesting an import authorisation for a medical product Argentina: Regulatory controls established for...

EU/US: Cooperation on development of UDI database specifications IMDRF: Assembly and technical guide for IMDRF ToC submissions IMDRF:...

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

SINGAPORE: HSA Informs Public Regarding Risk of Breast Implants BIA-ALCL is a cancer of the immune system and not a type of breast...

Updates on Eurasian Medical Device Regulations ARQon summarizes the most significant new medical device regulations changes in the...

Health Canada has revised the guidance document titled "Management of Applications for Medical Device Licences". This document outlines...

On 7 May 2019, FDA issued a document, “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program”. This...

Executive Summary: This month's Asian Medtech Associations Regulatory Networking discussions is split into two parts, the first being a...

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

NB Listed in European Commission’s New Approach Notified and Designated Organisations (NANDO) To date, two Notified Bodies have been...

On 25 March 2019, South Korea's Ministry of Food and Drug Safety (MFDS) published a notification titled "Professional revision of medical...

On 24 Apr, Malaysia MDA made an announcement regarding the placement in the market and use of non-registered device without clinical...

Executive Summary: Part 1 of this month's Asian Medtech Associations Regulatory Networking discussions features Asean medtech market...

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