TGA streamlines Class 1 electronic lodgement

The long anticipated changes to the TGA's online application process are about to be implemented as part of the launch of the new e-business (eBS) website. The changes apply only to Class 1 Devices that are non-sterile and do not contain a measuring function. This means that if your device falls into this category, you can start selling your product as soon as the online application is complete - no need to wait for the TGA to review. The online system will validate the application and trigger automatic entry onto the ARTG. Manufacturers - be warned that entries are subject to both random and targeted post market review. For more information click here.

Congratulations - Nanosonics Canadian Approval, Sunshine Heart IDE, Romar Engineering ISO 13485

Brandwood Biomedical is very proud to have supported three of our clients in their recent passing of some very significant milestones and we congratulate them on their achievement.

• Nanosonics have achieved Canadian approval for their Trophon Ultrasound Disinfector device. This in addition to the CE Mark they received earlier this year. Not content with this, Nanosonics has also recently applied for TGA approval, anticipates lodging US FDA 510(k) application before year end and in early 2009 commencing regulatory processes for Japanese market approval.


• Sunshine Heart Company, after an exhaustive FDA review, have received an IDE approval to conduct a US pilot clinical trial of their C-Pulse^TM non-blood contacting heart assist device. Sunshine expects to begin the trial very shortly.


• Romar Engineering have been successfully audited to ISO 13485 - completing the upgrade of their quality system from ISO 9001:2000. This achievement will strengthen Romars abilites as a specialist manufacturer of moulded medical device components.


• UniLife have achieved FDA approval for their UnitractTM 1mL Insulin Syringe giving Unilife a green light to commence product launch activities within the world's largest healthcare market, where the use of needlestick prevention devices is mandatory.

BioKorea

Brandwood Biomedical Principal Arthur Brandwood recently participated in the NSW trade delegation to Gangwon in the Republic of Korea, and the 2008 BioKorea conference and exhibition, which attracted over 20,000 delegates.

Korea has implemented a nationally funded and co-ordinated industry development programme which provides strong incentives for researchers to develop spin-out technologies and well targeted support for new companies from early R&D through to patenting, fund raising, regulatory, manufacturing and marketing. This has created a national pipeline for new company and product developments. The result - Korea is growing its research based industries (including Medical Devices) at breakneck pace.

We particularly acknowledge NSW Department of State and Regional Development, Austrade and the Gangwon Proviincial Government for their support of the trade mission.

See you at Ausbiotech!

We will be attending AusBiotech's annual conference to be held in Melbourne from 26-29 October. Our Principal, Arthur Brandwood will be co-presenting a Workshop on Clinical Evidence Requirements on Sunday afternoon and presenting in the session on Reimbursement on Tuesday 28^th at 4pm. Click here for the full conference programme.

If you would like to meet with us in Melbourne - please do contact us