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.
Health Canada Resources
Medical Device Regulations
Health Canada released its Guidance Document on Medical Device Compliance and Enforcement (GUI-0073)
Effective December 1, 2014 license applications for Class III and IV medical devices will be accepted by Health Canada electronically – no paper copy required
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
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
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.
The new regulations entitled ‘Fees in Respect of Drugs and Medical Devices Regulations’ came into effect on April 1, 2011.
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