Application Form for Custom-Made Devices and Medical Devices for Special Access
Cover Letter
Health Products and Food Branch
Medical Devices Bureau
Therapeutic Products Directorate
Rm. 1605, Main Stats Canada Bldg.
Tunney's Pasture : AL 0301H1
Ottawa ON K1A 0L2
June 8, 2001
To: Medical Devices Stakeholders
Subject: Application Form for Custom-Made Devices and Medical Devices
for Special Access
The attached revised application form entitled Application Form for
Custom-Made Devices and Medical Devices for Special Access sets out
the information requirements as outlined under Part 2, Section 71 of the
Regulations for applying for authorization that would permit the importation
and/or sale of a Class III or IV custom-made device or a medical device
for Special Access. It is intended to replace the existing application
and declaration forms published with the Therapeutic Products Directorate
(TPD) guidance document entitled How to Apply for Authorization to
Obtain Custom-Made or Special Access Devices dated March 25, 1998.
For approval following a request for a batch release, health care professionals
should use the updated declaration form as attached to notify the Bureau
each time a device is used.
In order to improve the quality of applications received and to expedite
the review process for Special Access, the accompanying document entitled
Instructions for Completing the Application Form for Custom-Made Devices
and Medical Devices for Special Access is provided to guide health
care professionals and industry on the subject.
Effective immediately, health care professionals are requested to complete
the attached new application form. Both the new and old forms which are
available electronically on the Health Canada web site at
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/ under the Special Access Programme
- Medical Devices along with the accompanying guidance documents will be
accepted during the transition period. Health care professionals are encouraged
to forward any comments that they may have for improvement of the forms and guideline.
The processing of Special Access requests is given a high priority within
the Medical Devices Bureau and provided that the regulatory requirements
of Part 2 of the Regulations are satisfied, requests are reviewed and
processed in less than three working days. However, health care
professionals are requested to apply to the Special Access Programme as
soon as they are aware of a surgical procedure which requires Special
Access. To avoid any requests for additional information and ensure that
your application is processed within three working days, please ensure
that your application is complete.
For more information on the Special Access Programme for medical devices,
please contact:
Manager, Device Evaluation Division, Medical Devices Bureau
Phone: (613) 954-0297; Fax: (613) 957-9969
E-mail: sap_devices_mdb@hc-sc.gc.ca
Further comments and suggestions regarding this form or the TPD guidance
document entitled How to Apply for Authorization to Obtain Custom-Made
or Special Access Devices should be directed to:
Melinda Ché, Special Access Programme, Device Evaluation Division, Medical
Devices Bureau
Phone: (613) 954-0172; Fax: (613) 957-1596
E-mail: melinda_che@hc-sc.gc.ca
or sap_devices_mdb@hc-sc.gc.ca
original signed by
Beth Pieterson
Director
Medical Devices Bureau
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