Health Canada Releases Information on MDL Screening Issues
Health Canada has unveiled new information on the most common screening deficiencies agency reviewers see in higher-risk medical device license applications.
The agency’s reviewers looked at applications during 2014 and early 2015 and documented issues that led to requests for additional information.
Areas of concern for Class III and IV applications included:
- Safety and effectiveness studies;
- Background information;
- Associated fees;
- Device and package labeling documentation;
- Manufacturing quality controls;
- Marketing history and regulatory status.
Health Canada processes most licensing applications without additional information requests. The agency approved 59 percent of applications without further requests in the first quarter of this year. — Jason Scott