Skip to main content
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter Archive

TGA webinar on Australian UDI implementation

The TGA is in the process of establishing the Australian Unique Device Identification Database (AusUDID). The TGA is hosting a webinar to provide an update on the Australian UDI implementation and a presentation on learnings and the real-world benefits of the UDI adoption in the US healthcare system. The webinar is held on 21 November from 11:30am to 12:30pm (AEDT).…
Tehelj
November 17, 2023
November 10, 2023 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive

Swissmedic weekly update (WC 06 Nov)

Please note this is an extract of the original bulletin. New information on submitting vigilance reports for medical devices Swissmedic has revised the information on submitting vigilance reports (incidents, trend reports and FSCA reports) for products according to the Medical Devices Ordinance (SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (SR 812.219)
Read More
November 3, 2023 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive

Swissmedic weekly update (WC 30 Oct)

Obligations for authorised representatives, importers and distributors The Medical Devices Ordinance (MedDO; SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219) set out requirements and responsibilities for operators in the medical devices supply chain. The following Information sheet outlines the roles and obligations of the Swiss authorised representative, the importer and the distributor. It also…
Read More
October 27, 2023 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive

TGA medical devices vigilance program pilot

The TGA is commencing a 12-month pilot of the new Medical Devices Vigilance Program. Sponsors who have medical devices included in the Australian Register of Therapeutic Goods can volunteer for the pilot. The pilot is designed to support medical device sponsors comply with regulation and give the public confidence that sponsors are meeting their responsibilities. More information on this program…
Read More
October 13, 2023 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive

Weekly update from GOV.UK for: Department for Science, Innovation and Technology

  New £60 million Regional Innovation Fund among measures to boost research and development Page summary: A £60 million Regional Innovation Fund (RIF) that will boost support for universities in areas with lower levels of R&D investment is among new measures Technology Secretary Michelle Donelan has announced.  
Read More