Australian Regulation of Medical Devices - is there a better way?

The Australian Senate Community Affairs Committee has established an inquiry into the regulatory standards for approval of medical devices. The terms of reference include the role of the TGA and the processes of regulation in Australia (both pre- and post-market) and there is a particular focus on orthopaedic implants.

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China and You

The seminar and networking party for our 10th anniversary was a huge success - with a full house in both the Sydney and Melbourne venues.  Thanks to all of our friends and partners who honoured us with their presence.  We were delighted to see you there and even more delighted at the energetic discussions and debates that took place in the seminars.

For those that missed the seminar, the slide set for Davey Han's very thought provoking presentation on the challenges and opportunities in the emerging Chinese market are available for download here.

Some key messages from Davey's presentation:

 

The China Medtech market growth is accelerating



There's an ambitious National Health Care Reform Plan which will see an additional $US 123 Billion of infrastructure and other funding over 3 years, delivering  22 thousand new local hospitals and clinics and about 1600 larger hospitals and that will see 90% of the population have some level of health care insurance by the end of this year...

The procurement program to supply the expanded hospital services is huge

China as a low price country is a myth...  There is a premium on advanced technologies which means that high tech devices particularly attract higher prices in China than in the USA.  Higher volume commodity products tend to be lower price - but of course the sales volumes are very large.

China Regulatory affairs is different for sure - but entirely manageable with the right knowledge and approaches and approval timelines are increasingly in line with major western agencies.  

Good regulatory knowledge is important - strategy is essential and there are ways of doing business that can accelerate your penetration of the China market.  For example did you know it's possible for some devices to deal with a provincial SFDA, and to obtain support from the provincial government for setting up your operations in China? Interested to learn more - contact us for a no obligation discussion about China and You. 

First Steps towards 510k reform

In response to growing concerns about the 510(k) process raised by numerous parties include the US Congress the FDA has initiated a review of the 510(k) program. As a first step the FDA has conducted an internal review and they have recently released these internal reports for public comment. The key findings and recommendations presented in the reports are outlined below:

• The de novo process was found to be significantly overburdensome and it is recommended that steps be taken to streamline the process including limiting the regulatory oversight based on appropriate risk assessment.
• To date it has been very unclear which 510(k) submissions require clinical evidence. The FDA proposes to establish a new Class IIb classification for products that would require clinical evidence in a 510(k) submission. 
• Introduction of a “Notice to Industry” system that would provide more timely guidance to industry on changing regulatory expectation, than the current formal guidance process.
• New and explicit requirements for manufacturers to submit a summary of all known scientific information related to the safety or performance of the device in a 510(k).  This is aimed directly at preventing the selective presentation of only favourable evidence to FDA.
• The FDA proposes to include much more detailed device information in 510(k) database including photographs, up-to-date labelling, design schematics as well as the FDA review decisions.
• FDA seems to be aware of a lack of expertise and consistency with its reviewers and are planning on taking steps to increase reviewer knowledge and consistency of review practices across the CDRH.

Note that all these are simply recommendations at this stage and open to public comment. Watch this space for announcements on comments!

It is still VERY early days in this process. The FDA has commissioned the Institute of Medicines to undertake an independent review of the 510(k) and their report is not expected until July 2011. Expect further consultations and eventually updates to the regulations and potentially the Act, all of which will take time.

In some ways these reforms represent some small steps towards the GHTF  regulatory model – this is essentially introducing a four step classification and is placing a greater emphasis on clinical evaluation – which, following the recent MDD reviews is now very explicitly part of the European requirements (and also in Australia and other jurisdictions).  There’s still a long way to go on the road to global harmonisation but a journey of a thousand miles starts with a single step…

The full reports are available here: http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm220272.htm

Josh Griffin
Josh@brandwoodbiomedical.com.au

Update on India

The requirements for medical device regulation in India continue to evolve.  The Indian Central Drugs Standard Control Organization have recently published the draft Guidance Document on Common Submission Format for Registration of Medical Devices in India.  This guidance sets out in detail the expectations of the Indian authorities for Device technical file, manufacturing information and certifications that must be submitted in support of Indian licensing application.  The content is based very much on the AHWP CSTD template and the GHTF STED.  The Submission requires specific information on overseas regulatory status - including both product registrations AND postmarket history.  This reflects a trend for emerging jurisdictions to look specifically at the overseas postmarket track record of new products. 

Arthur Brandwood
Arthur@brandwoodbiomedical.com.au

Help build a new regulatory system...

An interesting opportunity has come up for someone who wants to participate in building a new regulatory system from the beginning.  The Health Authority in Abu Dhabi is building a  new regulatory system for medicines and devices and they currently have a vacancy for an officer in device regulations.  Says our colleague Dr. Wafa A. el-Adhami: "The Authority, and Abu Dhabi, are exciting places to work - fast and exciting changes - with great focus on reforms.  Device regulation is in its early stages, with legislation, regulations and compliance systems design under development. So, this will be a great opportunity for someone with relevant expertise in regulations who is keen to contribute to creating the system and improving health and safety." Interested?  Contact wadhami@haad.ae to learn more.