China Update – What’s new with CFDA
In 2014 the China FDA instigated Decree 650, signaling a wholesale revision of medical device and IVD regulations. This has resulted by a range of new general and specific guidance’s, regulations and orders. Listen to Brandwood Biomedical Director of China Operations Steven Wen to hear what’s new in China.
Getting Paid for your Device – Reimbursement strategy in the US & UK
Did you know that one third of Americans receive their healthcare benefits via the government through Medicare, Medicaid or Veterans programs, and over half participate in some commercial insurance program mostly through one of just four companies? Watch and list to our complimentary Brandwood webinar “LIVE” to hear guest speaker Jonathan Sackier of Clinvue demystify US and UK reimbursement and look to the future evolution of reimbursement.
Clinical Evidence Requirements across multiple markets
We’ve been talking about Clinical Evidence quite a lot lately –that’s because regulators around the world have been toughening up on clinical evidence requirements for medical devices. More devices are required to have direct clinical trial data, and where literature based evidence is accepted, the standards are getting tougher. This webinar will help you to better understand how you can manage clinical evidence requirements across multiple markets.
Update on the Australian Regulatory Environment
Australia continues to be an attractive medical device market. It’s sophisticated, transparent and for implantable devices there are reimbursement schemes that deliver certainty of pricing. The national regulator continues to improve processes to streamline registration of medium to low risk produces based on European (CE) certification evidence, although there’s some way to go on dealing with backlogs of technical file desk audits (“application Audits”) for certain higher risk devices. This Webinar will provide an up to the minute overview of the Australian regulatory system and current issues.
Post Market Compliance – Keeping those hard won registrations
OK so you have your product registered. That’s just the start. It’s vital to stay on top of your postmarket obligations for the lifetime of the registration. That means paying attention to customer feedback, postmarket reporting and things like advertising and labeling compliance. This presentation takes a look at the key elements of postmarket compliance and how to manage it all, especially across multiple markets.
What’s changed in ISO 13845:2016
The long awaited 2016 update to ISO 13485 was published the end of February. Join Brandwood Biomedical to hear what’s changed! Learn about: Emphasis on risk management Flexibility to omit compliance to specific clauses Closer alignment to GHTF and IMDRF definitions and classifications. Moving away from ISO 9001 Updated Technical Content.
China Update – What’s new from CFDA
In 2014 the Earth shook as China FDA introduced Decree 650, signaling a wholesale revision of medical device and IVD regulations. This has been followed by a virtual torrent of new general and device specific guidances, regulations and orders. Struggling to keep up with all this change? Listen to Brandwood Biomedical Director of China Operations Steven Wen to learn what’s new in China in 2016.
2016 – The Year Ahead in Asia Pacific Regulatory Affairs
The pace of change doesn’t slow down… the past year saw sweeping reforms in China, reorganisation of the Korean agency and new administrative processes in that market, introduction of the new Medical Devices Law in Japan and the promulgation of the ASEAN Medical Device Directive and recommendations for substantial reforms in Australia. 2016 doesn’t look like slowing down. Webinar video coming soon.
Traps for the Unwary on quality systems – design controls before you manufacture
Design controls are a crucial element of a medical device manufacturers quality management system. They cover the development of a device from concept to commercialisation and apply to all changes to the device and the manufacturing process design, including your sub-contractors. It doesn’t stop there… Listen to Peter Austen, Senior Consultant explain what you need to do while in the development Phase.
Clinical Trials Down Under – skipping regulatory approvals
One of the most advantageous aspects of conducting clinical trials in Australia and New Zealand is the expeditious regulatory ‘notification-only’ scheme, enabling companies to initiate even first in human clinical trials quickly. Listen to our guest speaker, Suzanne Williams, of Mobius Medical to hear of the most advantageous aspects of conducting clinical trials in Australia and New Zealand.
Harmony with Strength
By comparing what happened recently in the regulatory frameworks of the major markets like Europe, Australia, USA, Japan and China, it is clear that the regulatory bodies are embracing and encouraging more harmonisation. The overall tendency now is to streamline the registration of lower risk devices and reduce duplications by utilising harmonization. Meanwhile, the regulatory bodies are strengthening the clinical evidence requirement for high risk devices and expanding the third party assessment.
Biological Safety Risk Managment
With the sensitivities available from modern analytical chemistry, a common theme in biological evaluation is a potential shift towards greater chemical characterisation and less reliance on biological tests – which are necessarily slower and more costly and possibly less sensitive. This presentation was delivered by Arthur Brandwood at the 2015 China International Medical Device Regulatory Forum (CIMDR).
The Oriental Express: The rapid evolution of China regulation
The Regulatory change proceeds at a break neck pace in China. The new regulations of November 2014 have led to a series of follow-up changes in requirements for Classifications, Clinical Trials, Submission Processes and now new Regulatory Fees.
View this webinar to gain an insight to where it’s all at in Beijing.
De-risking Regulatory Filings through Pre-Submissions
As regulators around the world are all engaged in substantial reforms – bringing in new requirements and raising the bar for compliance, it’s not surprising it can all seem a bit overwhelming and intimidating. The solution is perhaps simpler than it seems – conversation. This webinar outlines how the consultation process works, how to approach the regulator and how you can reduce time and cost of your submissions by having a conversation.
Australia’s ‘Fast Track pathway to device registration for local manufacturers
In October 2014, the Australian government changed the law to remove the requirement for local manufacturers to undergo direct TGA conformity assessment prior to registering their device. By removing this, local manufacturers are able to apply for device registration using CE certification. Watch this webinar or download the slides to learn how you can register your device in Australia using the ‘fast-track’ pathway.
Australian Reimbursement: The true costs of market entry
The value of a market is not just in the number of patients but in the price paid. In a webinar earlier this year, Sarah Griffin, Managing Director of our partner organisation Medtechnique pointed out that although the reimbursement process for prosthesis listing of implants in Australia is challenging, time consuming and expensive, there’s no shortage of applicants. It’s worth it because successful listing brings predictable long term national pricing in private hospitals. This webinar outlines how there’s much more to reimbursement than prosthesis listing.