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 Device [...]
12 04 2023
12 04 2023
12 04 2023
12 04 2023
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, 2019' [...]
12 04 2023
12 04 2023
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 the [...]
24 03 2023
24 03 2023
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 requisitos [...]
24 03 2023
24 03 2023
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 Medical [...]
24 03 2023
24 03 2023
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 formalises [...]
06 03 2023
06 03 2023
Everything you have to know to market your Devices in Switzerland
6 March 2023 Due to the absence of a mutual recognition agreement with Europe, there are several regulatory requirements for the [...]
16 02 2023
16 02 2023
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 of [...]
16 02 2023
16 02 2023
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 Devices [...]
16 02 2023
16 02 2023
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: for [...]
