On 01 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance on how medical devices will be regulated in the UK from 01 January 2021, following the UK departure from the European Union. What does this mean for Australian based medical device manufacturers wishing to place their device on the UK…
Personalised medical devices cover a range of products. Custom-made medical devices are medical devices designed and made as specified by a health professional to be used by a specific individual. They are not to be confused with mass-produced off-the-shelf devices that are customised, adapted or modified after supply, also known as adaptable medical devices. Custom-made…
The EU Medical Device Regulation (MDR) was the most significant regulatory change in Europe in over 20 years. The MDR entered into force in 2017 with a three-year transition period.* The MDR replaced the Medical Device Directive 93/42/EEC and several other directives. As of 26 May 2021, compliance with the MDR is now mandatory for…
SaMD: A need for Regulatory Reform in Australia In February 2019, the TGA issued a consultation for feedback from industry on how Software as a Medical Device (SaMD) is regulated in Australia. Currently, SaMD is regulated under the existing medical device framework, however a reform is required to keep up with the latest technological advances….
What is the Medical Device Single Audit Program (MDSAP)? The Medical Device Single Audit Program (MDSAP) was launched by the International Medical Device Regulators Forum (IMDRF) in 2014 as a pilot program, satisfying the requirements of the pilot program in December 2016. MDSAP allows a MDSAP recognized third party Auditing Organisation (AO) to conduct a…
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