INDIA: Import Licence Now Required for Class C and D Devices
On October 12, 2023, the Central Drugs Standard Control Organisation (CDSCO) published on its official website the Regulation of [...]
USA: FDA Inspections of Manufacturers Planned as of January 2024
Last October 2023, the Food and Drug Administration (FDA) updated the Compliance Programme Manual on its official website, which [...]
EUROPE: MDCG Mdcg Approved the Medical Device Software Guideline in Combination with Hardware
Last October 2023, the Medical Device Coordination Group (MDCG) approved the MDCG 2023-4 Medical Device Software (MDSW) - Hardware [...]
USA: 510(K) Submission Only With eSTAR Portal
On October 2, 2023, the FDA published an update to the Electronic Submission Template for Medical Device 510(k) Submissionsguidance: Guidance [...]
EUROPE: Cybersecurity for High-Risk Artificial Intelligence Systems
On September 11 2023, the European Commission published on its official website the Cybersecurity of Artificial Intelligence in the AI [...]
SWITZERLAND: Regulation of Devices Not Intended for Medical Use
On September 29, 2023, the Swiss Federal Council amended the Medical Devices Ordinance to improve the safety of products not [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
AUSTRALIA: TGA re-updates RES table for nanomaterials
On 29 March, Australia's regulatory agency, Therapeutic and Good Administration (TGA), updated its Medical Devices Essential Principles checklist by adding [...]
UK: MHRA updates vigilance guidance
On 24 April, the UK Medicines and Healthcare products Regulatory Agency (MHRA) updated the guideline Medical Devices: guidance for manufacturers [...]
