APEGS may, at its discretion, arrange for the exam to be held on an alternate date or another location in anywhere in the world.
Additional Information - A written request made under Section 84 for additional information necessary to determine whether the conditions set out in subsection 83(1) have been met.An Authorization for Investigational Testing will not be issued until a manufacturer and/or device sponsor has complied with the requirements of Sections 79 to 88 of the Regulations.This guidance document is intended to aid manufacturers and/or device sponsors in organizing and submitting an application for Investigational Testing Authorization for Class II, III and IV devices.Please refer to the attachment below named 'List of Law and Ethics Seminar Material' for further information.If you have any questions after reviewing all of the attachments below, please call Alex Chabun at 1-800-500-9547 (anywhere in North America) or 306-525-9547 (in Regina) or e-mail to [email protected]
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The purpose of this guidance document is to assist manufacturers and/or device sponsors in their preparation of the necessary documentation that is required to obtain an authorization for the sale of a device for investigational testing, under the .For more information on how to prepare an application for investigational testing for IVDD medical devices please contact: Medical Devices Bureau 2934 Baseline Road, Tower B Address Locator: 3403A Ottawa, Ontario K1A 0K9 fax: (613) 957-1596 original signed by: Beth Pieterson A/Director Medical Devices Bureau Attachments Document Number GD009/Rev00-MDB Replaces GD009/Rev DR-MDB DRAFT File name test_md3_Replaces test_md2_Version V3 Replaces V2 Date February 22, 1999 Date October 23, 1998 Change 1 Location Page 15, Section 7.2, first paragraph: with respect to mandatory problem reporting apply to devices undergoing investigational testing.February 22, 1999 The set out the requirements governing the sale, importation and advertisement of medical devices. The goal of the Regulations is to ensure that medical devices distributed in Canada are safe, effective, and meet quality standards.The seminar runs from am to pm on Friday and am to approximately pm on Saturday.
You will be notified of the exact location of the seminar and exam approximately two weeks prior to the date.
The investigator and/or the manufacturer are responsible to notify the Therapeutic Products Programme within 72 hours of any incident that meets the criteria as defined in Subsection 59(1) of the with respect to mandatory problem reporting apply to devices undergoing investigational testing.
The investigator is responsible to notify the Therapeutic Products Programme and the manufacturer within 72 hours of any incident that meets the criteria as defined in Subsection 59(1) of the This guidance document is intended to provide assistance to manufacturers and/or device sponsors in preparing the documentation necessary to obtain an authorization for the sale of a non-IVDD device for investigational testing under the .
The seminar is an excellent resource for preparing you for professional practice as well as for the exam.
Some of the material that is provided at the Law and Ethics Seminar is attached below, although not all material provided at the seminar is posted here.