Brandwood Biomedical Newsletter December 2009

Brandwood Biomedical Launch Office in Hong Kong

Brandwood Biomedical is delighted to announce the opening of a new local office in Hong Kong. We’re very excited about this development, which gives us the capacity to better support our clients in achieving regulatory approval across Asia. The Office was launched in November in conjunction with the inaugural Hong Kong Medical Devices Fair and Asian Harmonisation Working Party Conference.  Read on below for an update on AHWP.  

This is the first of a number of Asian regional offices for the company.  By developing a strong presence in Asia, we also look forward to working more closely with regional contract manufacturers and OEMs.

Do you need help in finding, assessing and qualifying the right contract manufacturer, or do you need support for regulatory approval in Asia? Contact us to talk.

 Introducing DevDx Clinical 

Brandwood Biomedical is proud to introduce DevDx Clinical, a full-service CRO dedicated to clinical diagnostics and medical devices. The company is a joint venture between Brandwood Biomedical and Australia’s leading data management and biostatistics consultancy Emphron. The combined expertise from both firms covers all phases of device and diagnostic product development, giving DevDx the capability to manage complete clinical trial programs or specific projects, from regulatory and ethical submissions to data management and statistical analysis. We understand that device and IVD trials are markedly different from Pharma trials and call for very different approaches.  For most CROs, these trials are a small adjunct to their Pharma Portfolio -  at DevDx, devices and diagnostics are our core business.  Click here for detailed information.

AHWP meets in Hong Kong

Brandwood Biomedical Principal Arthur Brandwood attended the Asian Harmonisation Working Party conference in Hong Kong from 4-7 November.  This conference brought together industry leaders and regulators from 27 countries across Asia and now includes a number of jurisdictions in the Middle East, South America and South Africa.

The meeting was striking for the clear resolve to develop an independent and comprehensive approach to regulatory development  which builds on the efforts of the GHTF.  Membership of AHWP continues to expand – with most South American and middle Eastern jurisdictions along with Russia either already members or about to join.  AHWP already includes the large markets of China and India.  This raises the possibility of just two global harmonisation groups – the 5 member GHTF and AHWP which encompasses all other significant markets.  Given the obvious energy and commitment at AHWP, the question arises as to which will be the most significant in the longer term.  See the new AHWP website at www.AHWP.info for full details on the activities and workplans.

TGA looks to tighten regulation of joint replacement implants

The TGA has released a proposal for the re-classification of certain orthopaedic joint replacements from Class IIb to Class III. The proposal affects replacements of the hip, knee and shoulder including both total and partial replacement s, but excluding ancillary devices such as screws and wedges. The move has been made to strengthen Australian regulatory control by bringing the regulations in line with the European Medical Device Directive.  The EU implemented the re-classification of total joint replacements from Class IIb to Class III in 2005 with the transition period ending in September 2010. The move was triggered by a number of factors, including the rising population of younger active patients requiring joint replacements and the high rate of revision for such implants.

What does this possible change mean for manufacturers of these implants or those looking to market such implants in Australia? Under the proposed changes, manufacturers would be obligated to comply with the more stringent requirements of a Class III medical device. This involves additional regulatory documentation detailing the design of the device, manufacturing processes and the intended performance of the device.  Any changes to an approved design must be approved by the conformity assessment body before the changes can be implemented. The proposed change will certainly incur more expense and resources for the manufacturer, with Class III devices requiring tighter post-market monitoring, tracking and recall. Although the changes will increase the regulatory burden for manufacturers if implemented, they will ensure closer alignment with European regulation and GHTF recommendations, reducing the danger of potential risks being introduced into Australia.  

TGA is inviting comments and input from the industry for the proposal, which can be viewed here.

 Happy Holidays!

And so we come to the close of yet another year as we gear up for Christmas and the New Year. Brandwood Biomedical will be closing the office on the 24^th December and will be back in business on the 4^th January. We wish all of our clients and friends the most relaxing and happiest of holiday breaks and look forward to working together in a successful 2010.