International - Press Release of the PIC/S Committee Meeting in Geneva (Switzerland), May-2018 Australia - Australian Regulatory...

THE THIRD MEDTECH ASSOCIATIONS REGULATORY NETWORKING discussion, hosted by Medtech Insight and sponsored by the ARQon consultancy...

During the HSA Industry Briefing held on 28 February 2018, all Class A Medical Devices (sterile and non-sterile) will have exception from...

Questions for ASEAN General Can we have the slides from the regulators update? What changes can to AMDD can be expected with EU MDR and...

At the latest HSA briefing held on 28 Feb 2018, it was announced that a revised regulation is targeted to be rolled out in June or July...

International - WHO Drug Information, Volume 31, No. 4 International - EDQM Press Release: The Ph. Eur. Revised its General Chapters on...

IMDRF: Essential Principles of safety and performance of medical devices and IVDs Click here for the full article on Global Regulatory...

Canada: Introduction of reduced MDSAP audit times Canada: Regulations affecting dental x-ray equipment have been amended Canada: Proposed...

Brazil: Medical device registrations valid for 10 years instead of five years Brazil: Good Manufacturing Practice certification of...

EU: Codes and corresponding device types, application forms, and application documentation for Notified Body designation EU: Conditions...

Australia: ‘Therapeutic Goods (Manufacturing Principles) Determination 2018’ Australia: Implementation of new Uniform Recall Procedure...

THE SECOND MEDTECH ASSOCIATIONS REGULATORY NETWORKING discussion, hosted by Medtech Insight and sponsored by the ARQon consultancy...

THE SECOND MEDTECH ASSOCIATIONS REGULATORY NETWORKING discussion, hosted by Medtech Insight and sponsored by the ARQon consultancy...

Australia: Articles that alter the pH of body fluids are not medical devices Australia: Up-classification of surgical mesh and provision...

Canada: Comments solicited on proposed new fees for medical devices and pharmaceuticals USA: Key provisions of the ‘FDA Reauthorization...

EU: Codes and corresponding device types, application forms, and application documentation drafted for NB designation EU: Products whose...

Brazil: New pathway added for GMP certification of international devices Brazil: Consultation held on extending validity term of...

IMDRF: Personalised medicine; final guidance documents; draft proposals on use of patient registry data ISO: New handbook on medical...

US: Mepergan Fortis Capsules; Final Decision on Proposal to Refuse Approval of Supplemental New Drug Application; Availability of Final...

Refering to the announcement issued by the Medical Devices Authority (PBPP) regarding the full enforcement of medical device registration...