Blog


TGA Release Proposal Paper: Are Tighter Controls and Alternative Options for Conformity Assessment Ahead?

The TGA have released a proposal paper introducing changes which could shake things up for Australian and overseas medical and IVD device manufacturers. The paper explores changes which could affect all companies entering the Australian market, particularly new medical devices which are higher risk (IIb, III and AIMD). In an attempt to improve control of devices and improve transparency, the following has been proposed. Mandatory Application Audits (MAA) changes. The potential overhaul includes two key actions; Expanding the list of devices requiring MAA which falls in line with recent changes to the......

Continue Reading


The Mutual Recognition Agreement between Australia and the European Union (EU), the EC MRA, facilitates medical device sponsors (entities or individuals who place medical devices on the market in Australia) to use CE Marking certificates as evidence of conformity to Australian regulatory requirements for some medical devices. Since being signed in 1998, the Agreement has provided a much shorter path to market in Australia for most CE Marked medical devices. However, the EC MRA has recently undergone changes which restrict previously covered devices. Changes came into affect on January 1 2013 and......

Continue Reading


Early Warning Mechanisms for Australia and New Zealand

The Therapeutic Goods Administration (TGA) and Medsafe, the Australian and New Zealand regulatory authorities for medical devices (and medicines) are in the process of developing an early warning system for adverse event and recall situations. The system is one of many projects being worked on as part of the creation of one regulatory agency, the Australian New Zealand Therapeutic Products Agency (ANZTPA)....

Continue Reading


GHTF Release New Standard

In light of the recent PIP breast implant adverse events and other significant device recalls,  the GHTF has finalised a new standard called N87 (based on a previous guidance document GHTF/SG2/N54:2006). The new standard outlines a system for medical device manufacturers and competent and regulatory authorities to exchange information regarding medical device adverse events electronically....

Continue Reading


Hip, Knee and Shoulder Joint Reclassification – TGA Announce Regulation Changes

From July 1 2012, hip, knee and shoulder joint implants will be classified as Class III medical devices according to the Therapeutic Goods (Medical Device) Regulations 2002. The change comes after the Therapeutic Goods Administration (TGA) consultation paper, Reforms in Medical Devices Regulatory Framework, was released in late 2010. Australia is not the only country to make such changes, a number of overseas countries have reclassified these products in an aim to improve safety and quality for patients....

Continue Reading


China: Reduced Clinical Trial Requirements Ease Regulatory Burden

It has been reported by law firm Sidley Austin that a new rule has been issued by the Chinese State Food and Drug Administration (SFDA) which is designed to simplify clinical trial requirements for manufacturers of Class II medical devices.  The rule is hoped to streamline regulatory review processes and timelines for eligible Class II medical devices....

Continue Reading


New EU IVD Regulations, Potentially In Line with Australian IVD Requirements

The European Commission is considering a number of key requirements, namely classification rules and clinical evaluation, for inclusion in the new IVD Regulation which will be potentially implemented in the European Union (EU) during 2015/2016.   These requirements echo changes made to the Therapeutic Goods (Medical Device) Regulations 2002 as amended which are specific to IVDs....

Continue Reading


International Medical Device Regulators Forum (IMDRF) Progresses

At a meeting held in Singapore the International Medical Device Regulators Forum (IMDRF) (initiated to carry out a similar role to the now disbanded Global Harmonisation Task Force (GHTF)) a number of progressions were made. The Forum includes international medical device regulators from Australia, Brazil, Canada, Europe, Japan and the USA and has an aim to strategically accelerate international medical device regulatory convergence. It is hoped that this will provide medical device manufacturers with a more efficient path to certification worldwide. As indicated above, the Forum has fundamentally similar objectives to the......

Continue Reading