Brandwood Biomedical Newsletter September 2007

Welcome to this first edition of the online newsletter of Brandwood Biomedical .

During the past 2 years Brandwood Biomedical has undergone significant growth and change. We are a growing company focussed on assisting clients in the medical devices sector to achieve their compliance requirements in a timely and professional manner.

As we grow - and the regulatory environment is undergoing rapid change, we have been looking for better ways to keep our clients informed. To do this we are proud to launch our new website , blog and this newsletter. We have also made a change in our name to Brandwood Biomedical.

Through this newsletter and the blog, we aim to bring you up to date information on the latest changes in regulation and the devices scene affecting your business. We hope you find it useful and informative and would welcome your feedback .

Where now for Australian 3rd Party Assessment?

Political opposition in New Zealand has led to the indefinite postponement of the joint Australia-NZ Therapeutics Products Agency (ANZTPA). This raises questions over the future of some important regulatory reforms - in particular the introduction of third party assessment for medical devices, which has been resisted in Australia, but strongly supported by New Zealand and slated to be introduced as part of the ANZTPA package. Read more in the Brandwood Blog

Essential Free Advice!

Did you know that several of the larger regulatory agencies offer detailed advice on their websites - and best of all its free! For Australia see TGAs guidances . For the US see the FDA's very comprehensive " Device Advice " Site. For Europe see guidances published by the UK MHRA

Relax - but only if you're in the queue

 

If you have an application in the queue with TGA to convert an existing approved medical device over to the new regulatory scheme, and were worried about the approaching deadline then you can relax a little, the Therapeutic Goods Amendment Bill passed parliament on August 16th. The effect of this legislation is that providing you have a valid* application submitted before the October 4 Deadline, then you are allowed to continue selling your approved device even if TGA has not been able to compete its assessment.

But beware - there's a sting in the tail. Another effect of the amendment is that TGA has to actively check all of the old listings and registrations and to determine if each of them is eligible for transition or should be cancelled.

Since TGA obviously can't start this review process until after the transition deadline expires, this means that some registrations will continue to appear on the ARTG after the October 3 deadline, even though the product is no longer eligible for supply (because the manufacturer hasn't submitted a new conformity assessment application).

Even though you will still be able to look these entries up on the TGA website, they will be "taken to have been cancelled" under the terms of the new law - and not permitted to be supplied.

So - make sure that you have a valid application in place for any existing products approved under the old (pre 2003) listing or registration rules. Or you won't be able to sell them come this October.

[*An application is valid only if it is made using the appropriate form and accompanied by the prescribed fee and contains all the necessary certifications and is complete.]

ISO 14971 Risk Management Standard updated

One of the most important standards for medical devices is ISO 14971 Medical devices - Application of risk management to medical devices.

The text has been revised with a number of important areas of clarification - particularly on interpretation and justification of risk control measures and documentation of residual risk.

The standard now includes detailed explanations of the context and rationale for its requirements.  Every device company must own, apply and be familiar with this standard.  You can buy it via standards Australia’s online shop