There’s much uncertainty and concern about the new IVD Regulation in Europe. The new regulations began this past European holiday weekend, and begin a lengthy transition to implementation. If you are wondering how this may work out, look Down Under, where at the end of June, Australia will complete its transition to new IVD Regulations (IVDR). We take a look at the lessons to learn from the Australian experience.
At long last China’s CFDA is moving on exemption of IVDs from in China trials with publication of a first list of Class II diagnostics proposed for approval without in-China clinical data.
On 17th May 2017, China FDA published a draft ‘Exemption List of Local Clinical Trial for Class II & Class III medical devices’. This is open for industry and user feedback with a deadline of 20th June 2017.
This will be the 3rd wave exemption list in China.
The new MDR is a long document, with interminable preambles and no quick way to get to the key Annexes.
So to help we have extracted the two key Annexes on Classification and Safety and Performance Requirements (Replacement for the Essential Requirements) into tow handy PDF documents.
Businesses wishing to market Class II Medical devices (or certain Class I and III) or IVDs in the USA are required to obtain premarket clearance through the 510(k) notification process.
When you’re considering the US market for your product, you may have spent hours browsing through the internet, reading through mountains of regulations, guidance documents and standards, researched published white papers and yet… you’ve not been able to answer one fundamental question, “Do you have the right 510(k) strategy?”
China regulatory submissions are notoriously challenging. All too often, the root cause is usually a misunderstanding of the regulators expectations and interpretation of the requirements. In an attempt to reach a common understanding, the CFDA’s Centre of Medical Device Evaluation (CMDE) recently hosted over 400 industry professionals and CMDE reviewers in Beijing for a 3 days intense training on In vitro Diagnostics regulation. Members of the Brandwood Biomedical Beijing team were there. We take a look at the outcomes.