Regulatory Updates

Environmental Regulations

  1. Environment and Climate Change Canada (Part 1)
  2. Environment and Climate Change Canada (Part 2)

British Columbia Recycling Legislation for Electrical Medical Devices starting July 2012

Beginning in July 2012, a new category of products, as Phase V, will become obligated under the Recycling Regulation of the Environmental Management Act of British Columbia. Phase V encompasses an expansive array of products, including electrical medical devices.

BC’s New Electronic Product Stewardship Program

British Columbia has enacted a new “Electronic Product Stewardship Program” that will affect all DIAC members selling products with battery driven or electronic devices in that Province.

Health Canada Resources

Health Canada Notice on Transition to IEC 60601-1 2005 3rd Edition

Health Canada Notice on Transplant Human Cells, Tissues and Organs

Medical Device Regulations

Guidance Document on Medical Device Compliance and Enforcement

Health Canada released its Guidance Document on Medical Device Compliance and Enforcement (GUI-0073)

Formatting of Class III and Class IV License Applications

Effective December 1, 2014 license applications for Class III and IV medical devices will be accepted by Health Canada electronically – no paper copy required

Product License Renewals for Discontinued Products

When manufacturers discontinue a consumable product and don’t renew their Health Canada product license, an issue arises over product that may remain on distributor and dealer shelves

Unique Device Identifiers

We have received the noticed below from the Food and Drug Administration (FDA) in the United States announcing the first phase of the Unique Device Identification Database which we are passing along to you for your information and guidance

Annual Medical Device Renewal and Suspension

It is the responsibility of the License Holder to apply for ‘renewal’ before April 1st of a calendar year (the first time before April 1st, 2012) including applicable fee payment.

Health Canada New Fees for Medical Devices

The new regulations entitled ‘Fees in Respect of Drugs and Medical Devices Regulations’ came into effect on April 1, 2011.

Summary Technical Documentation (STED) Guidelines

Health Canada has revised their Summary Technical Documentation (STED) Guidelines to facilitate the submission to Health Canada of STED-based device licence applications and licence amendment applications for Class III and Class IV medical.

DIAC Regulatory Affairs Committee Minutes

Read more about regulatory subject matter committee minutes. Each year there will be three installments of meeting notes

April 2015 Minutes

April 2014 Minutes

October 2013 Minutes

January 2013 Minutes