As of November 2012 the GHTF (Global Harmonization Task Force) is no longer operating as evidenced by several pieces of information. In it’s place the International Medical Device Regulators Forum (IMDRF) is working to “build on the strong foundation of
EU Team-NB adopted V3.0 Code of Conduct – Align to Recent Proposed Regulations
On 10 Oct 2012 The European Association for Medical devices of Notified Bodies (better known as Team-NB) issued a press release on the adoption of Version 3.0 of the Code of Conduct (CoC) for Notified Bodies under Directives 90/385/EEC (Active
Medical Devices Utilizing Tissues of Animal Origin New EU Commission Regulation
This post is on the newly published Commission Regulation (EU) No 722/2012 of 8 August 2012 “concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured
Draft ASEAN Medical Devices Directive (AMDD)
Consultation on AMDD “From the Singapore Health Sciences Authority – Updated 2 August 2012 – As part of efforts to enhance economic integration among ASEAN (Association of Southeast Asian Nations) member states, ASEAN has been working on developing a standardised framework
EC asks for further scientific study & draws 1st lessons from recent fraud on breast implants
From the Europa website the following press release was issued on 2 Feb 2012. The complete press release is below. The original press release may be viewed too. European Commission – Press release Medical devices: European Commission asks for further