Postmarket Requirements for Medical Devices: A Practical Guide
47
Introduction
Medical device manufacturers often make
changes to their marketed products during the
product lifecycle to adapt to changing regula-
tory requirements, evolving user needs, potential
safety concerns, and raw materials availability.
All medical devices that have been authorized by
Health Canada meet the safety and effectiveness
requirements of the Canadian Medical Devices
Regulations (CMDR).1
There is a wide range of postmarket product
changes, varying from very simple administrative
changes (e.g., updates to the device identifier or
device name) to complex changes in the design
or manufacture of the device.
This first section of the chapter discusses
medical device licensing in Canada. The sec-
ond section explains the medical device license
amendment framework under the CMDR. The
third section reviews the types of postmarket
product changes within the CMDR framework,
and the last section illustrates the amendment
application review process.
Medical Device Licensing
Medical Device Licenses
Medical device licenses (MDL) are required
for Class II–IV devices sold or imported in
Canada and are issued to manufacturers. These
manufacturers also can be considered origi-
nal manufacturers. Device licensing requires
manufacturers to comply with the CMDR
requirements for safety and effectiveness in
Sections 10–20 and labeling in Sections 21–23.
A third-party registrar, which is an entity
approved by Health Canada, issues and renews
the manufacturer’s quality management system
certificate and is responsible for assessing a
manufacturer’s initial and ongoing compliance to
the CMDR.
Health Canada maintains a database of all
licensed Class II–IV medical devices offered
for sale in Canada in the medical devices active
license listing (MDALL).2 MDALL is a tool for
users to search for medical devices licensed for
sale in Canada. Devices can be searched by com-
pany name, license name, device name, company
ID, license number, or device identifier.
Health Canada sends all existing MDL
holders an annual license renewal (ALR) pack-
age by 1 September of each calendar year.3 The
Postmarket Product
Changes: Canada
By Karen Fan, MSc, RAC, PEng, PMP
3
47
Introduction
Medical device manufacturers often make
changes to their marketed products during the
product lifecycle to adapt to changing regula-
tory requirements, evolving user needs, potential
safety concerns, and raw materials availability.
All medical devices that have been authorized by
Health Canada meet the safety and effectiveness
requirements of the Canadian Medical Devices
Regulations (CMDR).1
There is a wide range of postmarket product
changes, varying from very simple administrative
changes (e.g., updates to the device identifier or
device name) to complex changes in the design
or manufacture of the device.
This first section of the chapter discusses
medical device licensing in Canada. The sec-
ond section explains the medical device license
amendment framework under the CMDR. The
third section reviews the types of postmarket
product changes within the CMDR framework,
and the last section illustrates the amendment
application review process.
Medical Device Licensing
Medical Device Licenses
Medical device licenses (MDL) are required
for Class II–IV devices sold or imported in
Canada and are issued to manufacturers. These
manufacturers also can be considered origi-
nal manufacturers. Device licensing requires
manufacturers to comply with the CMDR
requirements for safety and effectiveness in
Sections 10–20 and labeling in Sections 21–23.
A third-party registrar, which is an entity
approved by Health Canada, issues and renews
the manufacturer’s quality management system
certificate and is responsible for assessing a
manufacturer’s initial and ongoing compliance to
the CMDR.
Health Canada maintains a database of all
licensed Class II–IV medical devices offered
for sale in Canada in the medical devices active
license listing (MDALL).2 MDALL is a tool for
users to search for medical devices licensed for
sale in Canada. Devices can be searched by com-
pany name, license name, device name, company
ID, license number, or device identifier.
Health Canada sends all existing MDL
holders an annual license renewal (ALR) pack-
age by 1 September of each calendar year.3 The
Postmarket Product
Changes: Canada
By Karen Fan, MSc, RAC, PEng, PMP
3