USA: Content Submission for OTS Software
On August 11, 2023, the Food and Drug Administration (FDA) updated the Off-The-Shelf Software Use in Medical Devices guideline about Off-The-Shelf [...]
19 09 2023
19 09 2023
19 09 2023
19 09 2023
MEXICO: Modified Change Management Requirements on Registration
On August 9, 2023, the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), the Mexican governmental body in charge of [...]
19 09 2023
19 09 2023
SAUDI ARABIA: As of September 1 Mandatory UDI for Medium and High-Risk Classes
Even in Saudi Arabia as of September 1, 2023, manufacturers must implement unique device identification (UDI) requirements for placing Class B, [...]
02 08 2023
02 08 2023
UKRAINE: European Regulation 2023/607 recognised for EC extension
Last July, the State Service of Ukraine on Medicines and Drugs Control (SMDC) announced that the extension period in the manner [...]
02 08 2023
02 08 2023
UK: template letter published for MDR extension alignment
On 3 July 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) published on its official website the EU MDR [...]
02 08 2023
02 08 2023
EUROPE: revised Q&A guideline extension MDR
On 18 July 2023, the European Commission published in the Official Journal of the European Union the updated guideline Questions&Answers (Q&A) [...]
07 07 2023
07 07 2023
UK: MHRA extends CE marking validity
Medicines and Healthcare products Regulatory Agency (MHRA) extended the timeframe for the acceptance of CE-marked Medical Devices and in vitro diagnostic [...]
07 07 2023
07 07 2023
MEXICO: Registration renewal and amendment management procedure changed
La Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) published in the Diario Oficial de la Federación on 10/05/2023 the update [...]
07 07 2023
07 07 2023
EUROPE: MDCG Guidance on significant change in Medical Devices has been updated
On 12 May 2023, the revision to MDCG 2020-3 Rev.1 Guidance on significant changes regarding the transitional provision under Article 120 [...]
07 06 2023
07 06 2023
CANADA: Changes to recall procedures and establishment licences (MDEL) planned
On 15 April, Health Canada published the Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences [...]
