Consultation: Draft Documents for Medical Devices Program

Unanticipated circumstances have caused delays in the posting of some information online. Notification of documents available "for comment" will be posted online and the actual documents will be released upon request.

The medical devices inspection program for importers, distributor and manufacturers of class I devices has been in place for 5 years. Health Canada has undertaken a review of the program and is proposing a significant revision to the program which is the assignment of a risk rating to observations noted during an inspection and to assign an overall rating to the inspection. These changes are outlined in the following two draft Guidance Documents that comments are being requested on.

Comments are Requested on the Following Documents:

• Draft Guidance on the Medical Device Inspection Program (GUI-0064)
• Draft Risk Classification of Medical Device Observations (GUI-0079)

These guidance documents are intended to assist the medical device industry in providing an overview of the inspection process as well as classification of observations noted during an inspection which complies with the regulatory requirements of the Food and Drugs Act (the Act), including Medical Device Regulations (the Regulations).

In addition, Health Canada is also requesting comments on two other draft Guidance Documents.

Comments are Requested on the Following Documents:

• Draft Guide to Recalls of Medical Devices (GUI-0054)
• Draft Guide for Investigation of Reported Medical Devices Problems (GUI-0065)

These guidance documents are intended to provide an interpretation of the complaint handling and recall requirements in order to assist the medical device industry in establishing an effective and timely system for conducting problem report investigation that complies with the regulatory requirements of the Act and Regulations regarding medical devices sold in Canada. The "Guidance for Medical Device Complaints Handling & Recalls" (GUI-0056) will replace the original version that was published in February 20, 2002.

Please see below to comment on all 4 consultations.

How to Get Involved

All four consultations below are open for comment starting May 29, 2009 until August 12, 2009. To request documents: Interested stakeholders who wish to provide comments can request an electronic copy of any one of the documents listed below via email at: MDCU_UCIM@hc-sc.gc.ca. To request an alternate format of the documents please contact us via e-mail, phone, fax or by mail. Please include in the subject line the title of the consultation document you wish to comment on.

Medical Device Compliance Unit (MDCU)
Health Products and Food Branch
250, Lanark Avenue
Ottawa, Ontario K1A 0K9
Phone: 613-954-6666
Fax: 613-954-0941
Email: MDCU_UCIM@hc-sc.gc.ca

Comments are Requested on the Following Documents:

• Draft Guidance on the Medical Device Inspection Program (GUI-0064)
• Draft Risk Classification of Medical Device Observations (GUI-0079)
• Guide to Recalls of Medical Devices (GUI-0054)
• Draft Guide for Investigation of Reported Medical Devices Problems (GUI-0065)

Comments received from stakeholders and interested parties will be reviewed after the 75 day comment period.

Interested parties are encouraged to provide comments and suggestions by August 12, 2009 on any of the above documents.

Reporting to Canadians

Health Canada will make the results of this consultation available on this Web site.

If you have any questions, contact us at MDCU_UCIM@hc-sc.gc.ca.

Yours truly
Original signed by
Diana Dowthwaite
Director General