Regulatory requirements for medical devices and IVDs in Serbia
£50.00
Unlock the key regulatory insights you need to successfully navigate the medical device and IVD landscape in Serbia
English
This article by Elena Makarova summarises the responsibilities of the regulatory authority, the legal framework for device regulation in Serbia, and the classification of medical devices and in vitro diagnostics (IVDs). It then sets out the requirements for product registration, including the documentation requirements, timeframes, and fees. The article also discusses the need for local authorised representation, as well as requirements for packaging and labelling, clinical investigations, and vigilance and post-market surveillance.
Specification: 16 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the August 2023 issue of the Journal of Medical Device Regulation.
