On 15 April, Health Canada published the Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences [...]
On 29 March, Australia's regulatory agency, Therapeutic and Good Administration (TGA), updated its Medical Devices Essential Principles checklist by adding requirements [...]
On 24 April, the UK Medicines and Healthcare products Regulatory Agency (MHRA) updated the guideline Medical Devices: guidance for manufacturers on [...]
17 January 2023 This Strategic Partnership will enable EMMA International and Thema to Increase Their Geographical Offerings for the Medical Device [...]
Last July, 22 FDA published the guideline Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct [...]
Through the document Clinical evidence guidelines for Medical Devices published last June, TGA has finally made available the most significant guidelines [...]
The Person Responsible for Regulatory Compliance (PRRC) is one of the most critical elements of MDR (EU) 2017/745 as the responsibilities [...]
This White Paper focuses on the figure of the European Authorised Representative (EU REP), who plays a fundamental role in the [...]
Performing technical safety tests is a key step in the procedure for accessing the Chinese device market and is particularly critical [...]
During last 5 May preliminary hearing, the Council of Ministers approved the draft of the Legislative Decree adjusting the national legal [...]
