CFDA last week published the “Administration announcement regarding the development of medical device clinical trials supervision and inspection work (2016, No. 98)” detailing plans to introduce a program of on-site inspections of device and IVD trials conducted in China.
Key features are:
- The inspections will be retrospective. As is always the case, the CFDA has wasted no time in implementing announced plans. The program started 1 June 2016 and will audit past daata for current trials.
- Focus will be on Class III device trials.
- The program is particularly looking to expose falsified data. The inspections will look at authenticity of data and legitimacy of samples used in IVD trials. There will also be cross checks with information contained in registration dossiers.
- Likely regulatory actions will include rejection of submissions or cancellation of registrations which are based on inauthentic clinical trial data.
It’s also noticeable that this announcement includes the same “Self-regulatory” option that was offered to drug manufacturers in the pharma trials crackdown. Manufacturers who know that their submissions are based on suspect data are invited to withdraw their registration submissions with no further penalty.
English translation (google Translate)
Seeking to supply medical devices in China? We have offices in Beijing and our bilingual regulatory team are expert at CFDA submissions and dossier preparations – including compilation of Clinical Evidence Reports and preconsultation submissions with the agency. Contact us now so we can explain how we can support you in China. Email firstname.lastname@example.org or call Grant Bennett on +61 2 9906 2984 (Sydney) or Steven Wen on + 86 (10) 8532 5809 (Beijing).