The Medicines Act 1981, which contains problematic definitions requiring many products that are listed as medical devices in most jurisdictions while categorised as medicines in New Zealand, was amended in 2013 and goes into effect on 1 July 2014. The modernised definitions of Medicines, Medical Devices and Therapeutic purpose will allow products such as Pregnancy Tests and Contact Lens Solutions previously listed as Medicines to be listed as medical devices, aligning NZ regulations more closely with international standards.
Archives for June 2014
In these days of UDI and electronic medical records accurate implant tracking may finally be achievable. So why are the Europeans contemplating paper implant cards?
We have long accepted the low-upfront-cost-with-high-long-term-consumerables pricing model as the norm for the car, digital music and expresso machine industry. However, when used in heamodialysis equipment, it has sparked an investigation into alleged dumping activities by European and Japanese manufacturers in China.
In an effort to support the ever growing MedTech space in Victoria, Brandwood Biomedical is now listed on the Victorian Governments TVP Technology Capability and Supplier Directory.
TFDA has published a public tender to request maintenance and update to its electronic regulatory submission management system. TFDA has budgeted 384,000 New Taiwan Dollar (approximately AUD $13,800) for this project to be completed by the end of 2014.
The consultancy firm Brandwood Biomedical, renowned for its technical, regulatory and commercial advisory services in medical devices and in vitro diagnostics, has now broadened its reach even further this last April, being one of only a few Quality and Regulatory firms to offer a complete package to Medical Device Manufacturers, Importers and Sponsors from around the globe into China, Australia and now by heading “across the ditch” to New Zealand.