Uncategorised
November 18, 2020

Further Changes To Medical Device Regulation

From 1 October 2020, the process by which the TGA includes Class I non-measuring, non-sterile medical devices in the Australian Register of Therapeutic Goods (ARTG) has […]
September 28, 2020

Changes To Class I Medical Devices

From early October 2020, the Therapeutic Goods Administration (TGA) will be implementing changes to the inclusion process for Class I non-sterile, non-measuring medical devices. These changes […]
August 28, 2020

Classification and Labelling Of Chemicals

Safe Work Australia has been working towards adopting the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Revision 7 for workplace hazardous chemicals under […]
July 14, 2020

NICNAS To AICIS

David Dwyer On July 1, 2020 NICNAS has now become AICIS (Australia Industrial Chemical Introduction Scheme). In this article I look at some of the differnces […]
June 5, 2020

Fast Tracking Product To Market: Beware Of FOMO!

Living in our new pandemic environment we are confronted with companies wanting to fast track their “response products” to market. While the TGA has a fast […]
April 7, 2020

PPE Regulation & COVID 19

With the current pandemic the TGA (Therapuetic Goods Administration) has made concessions on the supply of certain goods. Specifically, medical devices designed to be worn by […]
April 2, 2020

Importing For Covid 19 – A Warning

David Dwyer Below is taken from an email from Fredrik Gronkvist of chinaimportal.com. I find their advice very conservative and intelligent and below is no exception. […]
February 4, 2020

Changes For Dangerous Goods and Hazardous Chemicals

Stellina Popplewell The next version (7.7) of the Australian Dangerous Good Code is being drafted to align with Revision 21 of the United Nations (UN) Model […]
January 8, 2020
Hand Holding Clock

How can we minimise time and costs with the APVMA?

Gavin Hall Two of the most common questions we get from our clients are ‘why does the APVMA take so long?’ and ‘why is it so expensive’? The […]
December 4, 2019

Changes To Cosmetic and Industrial Chemical Regulations

Stellina Popplewell From July 1, 2020 a new scheme will be adopted to improve the regulation of industrial and cosmetic chemicals in Australia. We are moving […]
November 4, 2019

How NZ and Aust Are Handling Changes To The GHS

Stellina Popplewell New Zealand At Consultation Stage Your views are sought on the EPA’s proposal to update the current classification framework for hazardous substances to the […]
October 10, 2019

Is your ‘Approved’ source of active constituent still Approved?

Dr Sharon Gossage Each source (manufacturing site) of an active constituent must be separately approved by the APVMA.  There are some active constituents exempted from the […]