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
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 [...]
07 06 2023
07 06 2023
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 requirements [...]
07 06 2023
07 06 2023
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 on [...]
11 05 2023
11 05 2023
AUSTRALIA: faster registration if there is authorisation in Singapore
On 9 March 2023, the Australian Therapeutic Goods Administration (TGA) decreed that the Health Sciences Authority of Singapore (HSA) - Singapore's [...]
