CFDA’s Centre for Medical Device Evaluation (CMDE) has reversed course on pre-consultations – re-establishing arrangements for informal preconsultations with reviewers at the CMDE Offices. Read on to learn about “Open Window Friday”
Recent announcements from CFDA suggest that China is thinking again on the stringent requirements for manufacturers to conduct in-China clinical trials. The agency is accelerating the production of exemption lists and recent draft policy circulars open the door to acceptance of foreign clinical data and to post market trials of devices which address unmet clinical need. Is the pendulum starting to swing back?
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.
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.
In a quiet announcement from China’s Ministry of Finance last week, the Chinese government cancelled an array of administrative charges – including for drug and medical deice testing. Already type testing centres are cancelling charges, but there are traps here which may slow down testing processes