The TGA transition period for software-based medical devices that met the regulatory changes set on 25 February 2021 ends on 1st November 2024. You will have until 1st November 2024 to apply for a conformity assessment with the TGA and to include your device in the ARTG list under the new, higher classification. Contact us to help you with this transition and to assist you with TGA conformity assessment.
There are published guidance documents including checklists on how medical device manufacturers can demonstrate cybersecurity compliance. Checking your devices against these guidelines can help you prepare your technical files for submission and auditing.
The MDCG has released a revised document, MDCG 2022-4 Rev 2, Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD. This guidance document outlines the activities to be performed by notified bodies as part of the appropriate surveillance defined in Article 120(3e) MDR.
Choosing the right Notified Body for certifying your medical device is important. Factors such as costs, Notified Body review times should be considered when making this decision. We work with many Notified Bodies across different device groups.
The FDA Breakthrough Devices Program speeds up medical device development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization.
Need Australian TGA / European EU Rep or Asian Medical Device Representation? MEDICAL DEVICES LICENSE HOLDING / TGA SPONSORSHIP / EC REPRESENTATION Our latest service just launched and we’ve gone GLOBAL! Check out our website for more information and quotation. Compliance Management Solutions Melbourne, Australia (Head Office) E: gloizou@compliancems.com.au M: +61 433 124 266 W: https://compliancems.com.au
CMS can help you with your internal audit. Contact us to book your next internal audit. We are also hosting a three-day Auditor training session on May 14-16 2024. Contact us to book your spot.
