An analysis Health Canada data by Canadian medical device trade association MEDEC has found increasing review times and screening deficiencies for Medical Device License applications during the fourth quarter of 2012.
MEDEC claims that among Class II license applications, Health Canada reviewers found 52% of new and 10% of amended applications to have screening deficiencies during Q4 2012.
For Class III license applications, Q4 average market authorization timeframes increased by 19 days and 10 days, respectively, for new and amended submissions. Furthermore, 85% of new and 49% of amended applications had screening deficiencies, while 51% of new and 36% of amended applications generated additional information requests.
Average market authorization times also increased for Class IV applications in Q42012. Reviews of new applications increased in length by 13 days, and by two days for amended applications. Screening deficiencies were also cited by Health Canada in 78% of new and 43% of amended Class IV applications.
Regarding the high percentages of screening deficiencies reported by MEDEC, those figures may indicate that medical device manufacturers are not following Health Canada’s guidance documents for submission of license applications—or perhaps that the guidance documents themselves need to more clearly explain the process.