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 [...]
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) - [...]
UK/SWITZERLAND: MDR extension impact
On 28 and 29 March 2023, the British and Swiss governments announced that the extension period in the manner set [...]
EUROPE: Q&A guideline clarifies third MDR extension
On 28 March 2023, the European Commission published in the Official Journal of the European Union the guideline Questions&Answers (Q&A) [...]
INDIA: list of accredited laboratories published
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 [...]
VIETNAM: free sale for devices of certain classes
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, [...]
ITALY: when to promote devices freely
On 20 March 2023, the Ministry of Health published on the website of the Official Journal of the Italian Republic [...]
BRAZIL: Requirements for registration Anvisa effective March 1
The brazilian resolution RDC No.751/2022 Dispõe sobre a classificação de risco, os regimes de notificação e de registro, e os [...]
CHINA: More responsability for the Quality and Safety of Devices
On March 1, 2023 in China, the Rules established by the National Medical Products Administration (NMPA) and the Center for [...]
EUROPE: MDR Extension in the Official Journal
On 20 March 2023, Regulation 2023/607 was finally published in the Official Journal of the European Union EUR- Lex, which [...]
CANADA: new fees for Medical Devices from 1 April 2023
The Department of Health, Health Canada published the Fees in Respect of Drugs and Medical Devices Order, the annual adjustment [...]
SAUDI ARABIA: marketing authorisation required for low-risk Medical Devices and supplies
According to Circular No. MDS-CIR-001-V1/220324 published by SFDA (Saudi Food and Drug Authority, the Saudi Arabian Regulatory Authority for Medical [...]
EUROPE: Cybersecurity Directive (EU) 2022/2555
The topic of cybersecurity is increasingly important nowadays, especially in critical areas such as public health and the medical sector: [...]
CHINA: updated safety standards for electroMedical Devices
As previously announced, technical safety tests are a key component of the registration process for Medical Devices in China. In [...]
UK: MHRA increases registration fees for Medical Devices
During the consultation that ended on 23rd November, MHRA submitted proposals to change the mandatory registration fees for Medical Devices [...]
EUROPE: MDR transition period extension proposed and latest MDCGs
On 6th January, the European Commission issued a proposal to extend the transitional period under Art. 120 for MDR [...]
CANADA: Summary Reports required
Health Canada, the department of the Government of Canada responsible for national health policy, last 21st November issued a reminder [...]
UK: new ways of reporting adverse events
Last 28th October, MHRA (Medicines and Healthcare products Regulatory Agency) announced that starting from Monday, 5th December 2022, adverse events [...]
