Publication
New rules for MDEL holders: Health Canada’s terms and conditions authority
Amendments to the Medical Devices Regulations affecting the regulatory framework for medical device establishment licences (MDEL) are now in effect.
Canada | Publication | November 15, 2021
On October 25, President Biden issued A Proclamation on Advancing the Safe Resumption of Global Travel During the COVID-19 Pandemic (the Proclamation), revoking the COVID-19 travel bans that restricted the entry of nonimmigrants travelling from China, Brazil, India, Iran, South Africa, Ireland, the United Kingdom, and the Schengen Area.
The new Proclamation, effective on November 8, states that foreign nationals flying to the United States must be fully vaccinated against COVID-19 and provide proof of vaccination and proof of a negative COVID-19 test prior to boarding the plane to the US, with limited exceptions.
The Proclamation only applies to foreign nationals; US citizens and permanent residents do not have to provide proof of vaccination to fly home from abroad. They do, however, have to have a negative COVID-19 test result.
In a separate but related announcement, restrictions on non-essential travel through land ports of entry on the Canadian and Mexican borders were lifted on November 8 for vaccinated foreign travelers. Please refer here for an update on the lifting of cross-border travel restrictions.
Proof of the following vaccines is acceptable for entry to the United States by air or land:
“Fully vaccinated” means it has been two weeks since you received the second dose of a multi-dose vaccine or the first dose of a single dose vaccine. Receiving doses from any two different approved vaccines administered 17 days apart is acceptable. For example, if you received one dose of Pfizer and one dose of AstraZeneca, administered at least 17 days apart, you will be considered fully vaccinated.
A full 14 days must have passed since the day of your last dose of your COVID-19 vaccine series. For example, if you received your second dose of Pfizer on November 1, you will be considered fully vaccinated as of November 15.
The following travelers do not have to be vaccinated to board a flight to the United States:
Please note:
Yes – all travelers over the age of two, vaccinated or not, must have a negative viral COVID-19 (NAAT or antigen) test prior to boarding a flight to the United States.
If you are fully vaccinated, you must show proof of a negative COVID-19 test taken no more than three days prior to travel. If you are not fully vaccinated, you must show a negative COVID-19 test taken no more than one day prior to travel. If you have recovered from COVID-19 in the past 90 days, you must show proof of recovery and provide a letter from a licensed healthcare provider or health official.
If you are an unvaccinated foreign national who is allowed to fly to the US pursuant to a vaccination exemption set out above, you will be required to attest that:
If you also plan to be in the United States for longer than 60 days, you will also be required to attest that, unless you are eligible for an exemption:
Exemptions to the 60-day vaccination requirement:
CDC has issued a new contact tracing order that requires airlines to collect information from all passengers and crew members flying into or transiting through the United States from a foreign last point of departure.
The Proclamation will remain in effect until terminated by the President.
Publication
Amendments to the Medical Devices Regulations affecting the regulatory framework for medical device establishment licences (MDEL) are now in effect.
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