Country Are eIFUs allowed? For which users? Additional comments Australia Yes for: a) active implantable medical devices and their accessories b) implantable medical devices and their accessories c) fixed installed medical devices d) medical devices and their accessories fitted with…
A tabulated summary of the UDI requirements, with hyperlinks to the legislation, for Australia, Brazil, China, Egypt, the European Union, India, Korea (Republic of), Malaysia, Saudi Arabia, Singapore, Taiwan, Turkey and the USA. AUSTRALIA Links https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/unique-device-identification-udi-hub Comments In February 2021,…
Administrative and legal information Legal basis for the registration requirement Element that integrates the requirement Supplementary information 1.1 Application form · Article 153 of the Health Supplies Regulation (RIS) · Article 14 of the Federal Law of Administrative Procedure (LFPA)…
In June 2023, the US Food and Drug Administration (FDA) issued guidance entitled Content of Premarket Submissions for Device Software Functions1, to replace the old 2005 guidance entitled Content of Premarket Submissions for Software Contained in Medical Devices. A summary…
[Table here] Brazil Mexico Argentina Colombia Uruguay Chile* Venezuela Local sanitary licence(s) for the company ✔ ✔ ✔ ✖ ✔ ✖ ✔ Apostilled or consularised Certificate of Free Sale or marketing authorisation from the country of origin – translated from…
[Chart summarising the language requirements for labels and instructions for use by lay persons and professional users in the European Union.] Member State Language(s) required for lay use Language(s) required for professional use Source document Austria German German and English…
Introduction The following flowcharts, which show the establishment and product registration processes in Pakistan, have been adapted from slides presented by Dr Muhammad Sohail, Manager Quality, Regulatory Affairs & Management Systems (QREM) and Pharmacovigilance, Confidential, Pakistan, at the MedTech Summit 2022…
Country Electronic applications Timeframe Application process and documents required Fees Comments Germany Depends on the regional Competent Authority About 2 weeks Application forms vary from region to region, therefore the regional Competent Authority needs to be identified first. Documents usually required…
[This chart cannot be displayed in this search and must be viewed directly from the February 2022 Journal PDF.] Country Electronic applications Timeframe Application process and documents required Fees Comments Ireland ü About 10 working days after validation of the…
[This chart must be viewed directly from the November 2021 Journal PDF.] Country Electronic applications Timeframe Application process Documents required Fees Comments France X 3–10 days Download relevant documents from the CCIR website. Complete, print and sign the Application Form…
