CSPs).
(a) COVID-19
In response to the COVID-19 pandemic, the federal government
pursued Interim Orders and other policy changes intended to
expedite the development of COVID-19-related products, including
drugs, vaccines, hand sanitizers, disinfectants, personal
protective equipment, and medical devices (see
e.g., here and here). Both the federal and provincial
governments made regulatory changes to secure domestic drug
supplies and mitigate shortages (see
e.g., here and here). Many of these policies were passed on
an interim basis but still remain in effect.
Patent Act, adding a
provision that allowed the Minister of Health to apply for
authorization to make, construct, use, and sell a patented
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In the spirit of MedTech Europe s repeated and vocal calls
to delay the implementation of the IVDR (see previous article here), Team-NB, the trade
association representing 26 leading Notified Bodies, has issued a
direct message to the medical device industry.
The message is clear - as things currently stand, Notified
Bodies will not be able to cope with the titanic workload as a
series of waves hit:
the MDR comes into force in May
2021;
the IVDR comes into force in May
2022; and
the transition period expires in May
Post-market surveillance for
medical devices: Amendments to the
Medical Devices
Regulations (MDR) are being made to impose additional
post-market reporting requirements for Class II, III and IV medical
devices.
Medical device license holders and
importers will be required to proactively report certain foreign
risk communications and actions to Health Canada.
Medical device license holders will
also be required to create and retain summary reports which address
adverse effects, corrective actions, complaints and incidents.
Health Canada s power to
order assessments, studies and tests: Amendments to the
MDR and
Food and Drug Regulations (FDR) clarify the
conditions under which Health Canada can order license holders to
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As per the Amending Regulation for Regulation on Licensing
Medicinal Products for Human Use No. 31338 ( Amending
Regulation ) published on Official Gazette of December 18
2020, the Emergency Use Authorization (EUA) clause has been added
to the for Regulation on Licensing Medicinal Products for Human Use
( Regulation ). Therefore, vaccines, which will be used
in exceptional cases that seriously threaten public health and are
accepted as communicable diseases by the World Health Organization
or the Ministry of Health for which comprehensive data on efficacy,
safety, and quality as basis for licensing have not yet been
In response to the pandemic, we saw quick action and flexibility
from:
the
Canadian Intellectual Property Office
(CIPO) - deadlines from March 16 to August 28 were extended until
August 31. On December 14, the Trademarks Office began accepting
requests for expedited examination of trademark applications
associated with medical goods or services related to COVID-19;
the
Federal Courts - Federal Court (FC)
deadlines were suspended until June 29 or July 13, depending on the
province, and a number of hearings and patent trials were conducted
by Zoom. Federal Court of Appeal (FCA) deadlines continue to
be suspended for some appeals, but are being lifted for selected