While FDA regulates Blood Establishment Computer Systems (BECS) as medical devices as well as regulating the blood establishments themselves, many other countries take a different approach.

In Canada the blood establishment is regulated. Computer systems used in donor establishments are not considered medical devices and are regulated through the establishment licensing process. Unlike with the FDA, it is the blood establishment that makes the submission and the donor BECS itself is not treated as a medical device from a regulatory perspective. Thus the manufacturer of the donor BECS is not regulated directly in Canada.

Version 1.1, issued in October 2002, of the Health Canada guidance for BECS submission “Blood Establishment License Amendment Requirements for Information Technology Submissions” is at the link provided and provides some details that may be of interest for US manufacturers of BECS when planning their development, validation, and support. Canadian BECS

Computer systems for transfusion services are generally considered Class II Medical devices by Health Canada but they recommend sending labeling and requesting classification since some could be a higher class depending on its function and interfaces.

Other Health Canada web links that may be of interest regarding medical device regulation:

• http://www.hc-sc.gc.ca/hpfb-dgpsa/bgtd-dpbtg/lic_amend_october2002_final_e.html
• http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/medical_devices_e.html