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 [...]
EUROPE: MDR Annex XVI Common Specifications’ draft Act approved
Last 13th October, with much anticipated vote, the Medical Devices Committee of the European Commission voted on the draft Implementing [...]
BRAZIL: ANVISA updates market access requirements for Medical Devices
Last 15th September, ANVISA (Agência Nacional de Vigilância Sanitária), the Regulatory Authority of the Medical Devices and IVD market in [...]
CHINA: no more paper registration certificates
Last 26th October, the Center for Medical Device Evaluation (CMDE) of the di NMPA (National Medical Products Administration) issued the [...]
ITALY: Ministry of Health issues document on surveillance requirements
Last 11th October, the Italian Ministry of Health issued the document “Vigilanza sugli incidenti con i Dispositivi Medici” which provides [...]
USA: FDA issues electronic template for 510(k)
On 22 September, FDA issued the Electronic Submission Template for Medical Device 510(k) Submissions, a document that provides specifications on [...]
USA: FDA updates fees for 2023
On 5 October, FDA published the Medical Device User Fee Amendments (MDUFA), a document containing updates on the registration fees [...]
EUROPE: Best Practice for Technical Documentation submission
Despite MDR coming into force in 2017 and fully enforceable on 26 May 2021, it is still unclear for medical [...]
