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 [...]
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 [...]
On 9 March 2023, the Australian Therapeutic Goods Administration (TGA) decreed that the Health Sciences Authority of Singapore (HSA) - Singapore's [...]
On 28 and 29 March 2023, the British and Swiss governments announced that the extension period in the manner set out [...]
On 28 March 2023, the European Commission published in the Official Journal of the European Union the guideline Questions&Answers (Q&A) entitled [...]
On 7 March last, the Central Drugs Standard Control Organization (CDSCO) issued Notice No.29/Misc/03/2019-DC (211) List of the certified Medical Device [...]
On 3 March 2023, Decree 07/2023 'Amendments To Government's Decree No. 98/2021/Nd-Cp Dated November 08, 2021 Prescribing Medical Device Management, 2019' [...]
On 20 March 2023, the Ministry of Health published on the website of the Official Journal of the Italian Republic the [...]
The brazilian resolution RDC No.751/2022 Dispõe sobre a classificação de risco, os regimes de notificação e de registro, e os requisitos [...]