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 [...]
EUROPE: MDCG 2022-14 | Immediate actions planned to facilitate transition to MDR/IVDR
To this date, it is still difficult for Manufacturers to embark on an MDR or IVDR certification pathway in a [...]
EUROPE: published guideline on borderline devices according to MDR and IVDR
The published version 1 of the Manual on borderline and classification for Medical Devices under Regulation (EU) 2017/745 on medical [...]
ITALY: MDR/IVDR adaptation decrees in force
On September 28, 2022, the two decrees for the adaptation of Italian regulations to the provisions of MDR (EU) 2017/745 [...]
US: GUDID entry deadline extension for Consumer Health Products
Last July, 22 FDA published the guideline Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, [...]
AUSTRALIA: published reference text for clinical evaluation
Through the document Clinical evidence guidelines for Medical Devices published last June, TGA has finally made available the most significant [...]
UK: possible extension of CE marking validity
In order to avoid a blockage of healthcare supplies in the territory, MHRA (Medicines and Healthcare products Regulatory Agency) is [...]
THAILAND: preferential route for devices already registered in Singapore
On 20th June 2022, the TFDA (the Thai FDA) established the expansion of the Singapore Reliance Route programme, initially tested [...]
SAUDI ARABIA: UDI extended to 2023-2024
The SFDA (Saudi Food and Drug Authority, the Saudi Arabian Regulatory Authority for Medical Devices and IVDs) announced a one-year [...]
USA: platform status for 510(k) submission
The FDA is constantly recruiting personnel to test the Customer Collaboration Portal (CCP) functionality. This portal is already active to [...]
CHINA: updated safety standard for electroMedical Devices
Performing technical safety tests is a key step in the procedure for accessing the Chinese device market and is particularly [...]
MDCG 2019-9 guidance on the Summary of Safety and Clinical Performance updated
The Medical Device Coordination Group (MDCG) on 24 March 2022 released the updated guidelines on the Summary of Safety and [...]
