Feb 18, 2013
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.
The medical device regulators of Australia, Brazil, Canada and the US have all signed on to a statement of cooperation to develop a single audit program for medical devices to be used by all four market authorities.
Upon implementation of the MDSAP program, the audit of a medical device manufacturer’s quality system in any one of the four participating countries will meet regulatory requirements of all four countries—a significant move that could ease medical device company’s paths to market in these regions.
According to MEDEC, the Canadian medical device industry trade association, Health Canada’s Medical Devices Bureau (MDB) faced a persistent backlog last year when it came to processing
The number of Medical Device License (MDL) and amendment applications to Health Canada’s Medical Devices Bureau (MDB) has declined over the first quarter of 2012, according to Canadian medica