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….
Unlike other markets (i.e. Canada, the US, the UK and parts of Europe) CBD is more strictly controlled in Australia, and the pure extracts (as well as any associated products) are considered Schedule 4 prescription drugs under the Poisons Standard. One of the top questions I get asked as a medicinal cannabis consultant is: “Can…
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…
Recent presentations given about South African Medicinal Cannabis CannaTech and Sandton Cannabis Expo 2019 During the month of November 2019, the PharmOut team attended the CannaTech Conference in Cape Town, South Africa for 2 days to learn more about the South African Medicinal Cannabis market. Following on from that, the team headed up to the…
Quality Management System software providers have matured in recent years, with an increasing number entering the Pharmaceutical and Medical Device industries and marketing themselves as 21 CFR Part 11 and ISO 9001 compliant. The fact is that QMS software providers have all gone to the cloud with many offering a purely web-based service. Only a…
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