All medical devices entering the Canadian market, whether locally manufactured or imported, need to be licensed by Health Canada, the Canadian medical device authority.
Canadian medical device regulations classify medical devices into four categories, I, II, III, and IV, based on the risk of use of the device, such as Class I devices are the lowest risk and Class IV devices are the highest risk. For this reason, the product registration requirements for manufacturers are also increasing, requiring manufacturers to implement the system is more and more detailed.
Class I medical devices are exempted from registration. Class II, III, and IV devices are required to be registered as follows:
1. Generic registration information:
a) Name of the device;
b) Classification of the device;
c) Marking of the device;
d) Manufacturer's name and address appearing on the label;
e) If the place of manufacture is not the same as the place of manufacture, the manufacturer must be registered. p>e) if the place of manufacture is different from d), the name and address of the place of manufacture;
2. Additional information for registration of Class II devices:
a) a description of the purpose and use of the device for the medical condition for which it is manufactured, marketed, or distributed;
b) a list of the standards met to satisfy the requirements for safety and effectiveness;
c) a statement of compliance with safety and effectiveness made by a high-level supervisor of the manufacturer;
c) a statement of compliance with safety and effectiveness made by a high-level supervisor of the manufacturer; and
c) a statement of compliance with safety and effectiveness made by the manufacturer's supervisor.
d) a statement by a senior executive of the manufacturer that the labeling of the device complies with the Canadian Medical Device Regulations;
e) in the case of a near-patient in vitro diagnostic device (i.e., a device that is not intended for use in a hospital, but for use in, for example, the home), a statement by a senior executive of the manufacturer that investigational testing has been conducted with human subjects, representative of the intended user, under conditions similar to those of the intended use. conditions similar to those of the intended use;
f) a CAN/CSA-ISO 13485-98 system certificate issued by a CMDCAS accredited body.
3. Additional conditions for registration of Class III devices:
a) a description of the device and the materials used in its manufacture and packaging;
b) a description of the performance of the device as manufactured, marketed and distributed under its permitted medical conditions, purposes and uses;
c) a list of countries other than Canada in which the device has been authorized to be marketed, the number of units sold and the number of reported problems and recalls;
c) a list of countries in which the device has been authorized to be marketed, with the exception of Canada. problems and recalls;
d) a list of standards used in the design and manufacture of the device to meet safety and effectiveness;
e) if the device is sold sterile, a description of the sterile method;
f) a description of the studies conducted by the manufacturer to determine safety and effectiveness and the conclusions drawn therefrom;
g) the device label/copy;
h) in the case of a near-patient in vitro diagnostic device, the use of human substances representative of the intended user of the purpose in order to test the device in studies conducted under conditions similar to the conditions of use;
I) literature citations of all publicly available reports related to use, safety and effectiveness;
j) a CAN/CSA- issued by a body accredited by the Canadian Certification Authority for Medical Devices. ISO 13485:98 certificate.
4. The additional material for Class IV medical devices is:
a) a description of the device and all materials used in its manufacture and packaging;
b) a description of the characteristics of the device for the medical conditions, purposes, and uses for which the device is permitted to be manufactured, marketed, or distributed;
c) the countries in which the device has been approved for sale outside of Canada, the number of units sold, and the number of reports of problems and recalls of devices;
c) a list of the countries in which the device has been approved for sale outside of Canada and the number of reports of problems and recalls of devices; and
d) Risk assessment including risk analysis, risk evaluation, and measures to meet safety and efficacy requirements for evaluating risk;
e) Quality programs related to the device, such as specific quality practices, resources, and procedures for taking action;
f) Parameters of materials used in manufacturing and packaging;
g) The manufacturing processes of the device;
g) The device's manufacturing process;
h) a list of standards used in the design and manufacture of the device to meet safety and efficacy requirements;
I) details of all studies carried out by the manufacturer to demonstrate that the safety and efficacy requirements have been met, including: i) preclinical and clinical studies; ii) process validation studies; iii) software validation studies where applicable, and iv) literature studies;
j) in the case of non-in vitro devices, the quality practices, resources, and actions taken; and p>j) in the case of a device that is not an in vitro diagnostic device, a device derived from animal tissue or tissue derivatives, objective evidence of biosafety;
k) in the case of a near-patient in vitro diagnostic device, details of research testing of human material representative of the intended user and under similar conditions of use;
l) the conclusions reached by the manufacturer in accordance with the studies in paragraph (I);
m ) a general description of the studies conducted by the manufacturer pursuant to subsection (h) and the conclusions drawn therefrom;
n) publicly published reported literature relating to the use, safety and effectiveness of the device;
o) a copy of the device labeling;
Reconfirmation of a medical device licence shall be submitted by the manufacturer to Health Canada on November 1 of each year following issuance. Cancellation of a manufacturing license shall be filed within 30 days of the cessation of sales in Canada. The Canadian Medical Device Regulations require manufacturers to implement an incident alert reporting system.