By Stewart Eisenhart, Emergo Group
A new Health Canada report on regulatory inspections of domestic and foreign medical device companies active in the Canadian market has shown a 98% overall compliance rate among importers, manufacturers and distributors.
Health Canada inspected a total of 2057 Medical Device Establishment License (MDEL) holders over the course of the regulator’s 2012-2013 fiscal year, citing 3251 observations of noncompliance with various sections of the Canadian Medical Device Regulations.
Most common observations cited involved documentation issues (section 45(g) of the CMDR); recall procedures (section 58(b)); and investigation procedures (section 58(a)).
Source: Health Canada
Health Canada organized cited observations into three risk-based tiers: 1 (high risk), 2 (moderate risk) and 3 (low risk). Less than one percent of citations included in the report fell into the Risk 1 category, while most (69%) were classified as Risk 2. Of the 13 total Risk 1-level observations made by Health Canada, the most (six) involved sales or imports of unlicensed medical devices.
By and large, MDEL holders seem able to comply with Canadian licensing regulations on a high level. Health Canada’s findings suggest the need, however, for closer attention to process and procedural requirements of the CMDR for some companies.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.