Regulatory Affairs Professionals Society 9 Investigational Testing and Special Access Programme By Annie Levesque, MSc, RAC (CAN) and Jennifer Cabralda, RAC (US, CAN) Chapter 2 CHAPTER OBJECTIVES ‰ ‰ Understand the regulatory framework for medical device clinical trials in Canada. ‰ ‰ Explain the requirements for medical device investigational testing authorization. ‰ ‰ Understand the postapproval requirements for the conduct of medical device clinical trials in Canada. ‰ ‰ Understand the regulatory framework for devices obtained through the Special Access Programme and custom-made devices. ‰ ‰ Review the application and approval processes for devices obtained through the Special Access Programme and custom-made devices. ‰ ‰ Understand the obligations of the healthcare professional and manufacturer/importer under the Special Access Programme. REGULATIONS AND GUIDELINES COVERED IN THIS CHAPTER Investigational Testing Authorization ‰ ‰‰ Medical Devices Regulations, Part 3 (SOR/98-282) ‰ Health Canada, Guidance Document: Preparation of an Application for Investigational Testing—Medical Devices (February 1999) ‰ ‰ Health Canada, Guidance Document: Preparation of an Application for Investigational Testing—in vitro Diagnostic Devices (February 1999) ‰ ‰ Health Canada, Policy: Management of Applications for Medical Device Licences and Investigational Testing Authorizations ‰ ‰ Health Canada, Guidance Document: Preparation of Drug Regulatory Activities in the “Non-eCTD Electronic-Only” Format (October 2016) ‰ ‰ Health Canada, Policy: Drug/Medical Device Combination Products (March 2006) ‰ ‰ Health Canada, Policy: Recall Policy (POL-0016) (March 2015) ‰ ‰ Health Canada, Guidance Document: Mandatory Problem Reporting for Medical Devices (October 2011) Special Access Programme ‰ ‰ Health Canada, Guidance for Health Care Professionals on Special Access and Custom- Made Medical Devices (February 2016) ‰ ‰ Medical Devices Regulations, Part 2 (SOR/98- 282) ‰ ‰ Application Form for Custom-Made Devices and Medical Devices for Special Access (Ver. 2011)
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