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Differences in Drugs and Devices and Implications for Reimbursement in Australia

In Australia, the implantable medical device market has had some tough times over the past couple of years. However, most of the uncertainty regarding pricing has been largely resolved with...
China continues its massive update of Medtech standards Brandwood Biomedical Global Medical Device and IVD Regulatory Services

China continues its massive update of Medtech standards

China is continuing its efforts to modernise the national technical standards infrastructure. Back in 2015, CFDA announced a plan to bring forward a complete update of technical standards, with the...
In these days of harmonisation and mutual recognition, who has the best device regulatory passport Brandwood Biomedical Global Medical Device and IVD Regulatory Services

In these days of harmonisation and mutual recognition, who has the best device regulatory passport?

It's almost 30 years since the establishment of the Global Harmonisation Task Force (GHTF), now replaced by the IMDRF.  The GHTF essentially produced guidances built on the European regulatory model...
This China regulatory change for IVDs will save up to 90% of clinical trial costs Brandwood Biomedical Global Medical Device and IVD Regulatory Services

This China regulatory change for IVDs will save up to 90% of clinical trial costs

China's CFDA exempts many devices and IVDs from requirements for clinical trials to support registration. Two weeks ago CFDA released their latest "4th Wave" of proposed clinical trial exemptions, which...
CFDAs 4th Wave exempts another 85 devices and 277 IVDs from Clinical Trials Brandwood Biomedical Global Medical Device and IVD Regulatory Services

CFDAs 4th Wave exempts another 85 devices and 277 IVDs from Clinical Trials

On June 11, 2018, CFDA released their latest proposals for medical device and IVD clinical trial exemptions covering another 85 devices and 277 IVDs. This proposed "4th wave" exemption list breaks...
Advice on change registration for applicants manufacturers Chinese name-brandwood-biomedical-global-expertise-medical-device-regulatory-compliance-australia-china-new-zealand

Advice on change registration for applicants & manufacturers’ Chinese name

On November 2, 2017, Chinese Food & Drug Administration (CFDA) released a new regulation which requires overseas applicants/manufacturers to include the standardized Chinese translation of company information within their applications....
Are Doctors Fees Threatening Private Health Insurance in Australia - brandwood-biomedical-global-expertise-medical-device-regulatory-compliance-australia-china-new-zealand

Are Doctor’s Fees Threatening Private Health Insurance in Australia?

Australia has a universal healthcare system (Medicare). There is also has a private health insurance option that covers admissions into private hospitals. It is understandable that most Australians who are...
TGA Determines 3D Proposed Changes still need work brandwood-biomedical-global-expertise-medical-device-regulatory-compliance-australia-china-new-zealand

TGA Determines 3D Proposed Changes still need work

In what was not a surprise based on the industry feedback, the Australian regulator of therapeutic goods (Therapeutic Goods Administration) will return to the drawing board with their proposed changes...
TGA Introduces Class Application Fees Brandwood Biomedical Global Expertise in Medical Device Regulatory Compliance Australia China New Zealand

TGA Introduces Class I Application Fees

In a surprising turn, the Therapeutic Goods Administration (TGA), Australian regulator of therapeutic goods, has announced the introduction of an application fee for Class I devices. Until now, class I...
Window opens for TGA Fee Exemptions brandwood-biomedical-global-expertise-medical-device-regulatory-compliance-australia-china-new-zealand

Window opens for TGA Fee Exemptions

Manufacturers who have TGA registrations but haven’t yet started sales can claim relief from TGA annual charges – but only if they act very quickly. Through the TGA’s Annual Charge...

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