Revised Medical Device Definitions Implemented in New Zealand – Effective 1 July 2014
In preparation for the merge of the Australian Therapeutic Goods Administration (TGA) and New Zealand (NZ) Medsafe, Medsafe have published a change the existing process for definin
Medical Device Software – Potential for Consistent Regulation in Asia
The Asian Harmonization Working Party (AHWP) has published a white paper on medical software for comment. The AHWP has developed the paper in conjunction with the EU and the US wit
Medical Devices in Malaysia – Tips to Master Market Access!
Malaysia has a well established regulatory system for medical devices governed by the Health Sciences Authority (HSA). The market has a reputation for being difficult to enter from
European Union Commission Release New Vigilance Guidance
The EU Commission have released revision 8 of MEDDEV 2.12-1: Guidelines on a Medical Device Vigilance System. The updated version includes guidelines for In Vitro Fertilisation (IV
Electronic Age: UK MHRA Issue Guidance On eIFU Requirements
The EU regulation on electronic Instructions for Use (IFU) (Regulation 207/2012) came into force on March 1st 2013. In response to the implementation of electronic IFUs, the UK Med
