1. general registration data:

a) Name of the device;

b) Classification of instruments;

c) Identification of the device;

d) The name and address of the manufacturer appearing on the product label;

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) Description of the purpose and use of medical conditions for the device manufactured, sold or agent;

b) A list of standards to meet safety and effectiveness requirements;

c) Declaration of safety and effectiveness compliance made by the top supervisor of the manufacturer;

d) A declaration that the label of the device made by the top supervisor of the manufacturer complies with the Canadian medical device regulations;

e) If the equipment for diagnosis of near-patient patients is not in hospital but used in the home, the senior supervisor of the manufacturer shall declare that the human substance representing the intended user has been tested for research under similar conditions as expected use conditions;

f) Can / csa-iso 13485-98 system certificate issued by cmdcas Accreditation Authority.

3. Additional conditions for registration of class III devices:

a) Description of the apparatus and materials used in its manufacture and packaging;

b) Description of the performance of the devices manufactured, sold and agent under the medical conditions, purposes and uses they agree to;

c) List of countries, number of sales, reported topics and recall of devices approved for sale except Canada;

d) List of standards adopted by the design and manufacture of the device to meet the safety and effectiveness;

e) If it is a device sold aseptic, the aseptic method is described;

f) The research description and the conclusions drawn by the manufacturer for safety and effectiveness;

g) Device label / copy;

h) If it is a near disease outside diagnosis equipment, the human body substance representing the intended user is used to study and test the situation under similar conditions of use;

1) All references to published reports that are publicly published in connection with use, safety and effectiveness;

j) Can / csa-iso 13485:98 certificate issued by an institution accredited by the Canadian medical device certification authority.

4. Additional materials for class IV medical devices are:

a) Description of all materials in the process of equipment and manufacturing and packaging;

b) Description of the characteristics of the device for the medical conditions, purposes and uses of the devices manufactured, sold or agent;

c) The number of sales of devices in countries other than Canada that are permitted to sell, as well as the reporting of the subject matter and recall of the devices;

d) Risk assessment includes risk analysis, risk assessment, and measures to meet the safety and effective requirements of risk evaluation;

e) Quality plans related to the device, such as specific quality practices, resources and procedures for action;

f) Parameters of materials used in manufacturing and packaging;

g) The manufacturing process of the equipment;

h) List of standards used in design and manufacturing to meet the requirements of safety and effectiveness;

1) The specific conditions of all studies conducted by the manufacturer to confirm that the safety and effectiveness requirements are met, including: I) preclinical and clinical studies; II) process validation study; III) software validation studies, where applicable, and IV) literature studies;

j) If it is not an in vitro diagnostic device or an instrument derived from animal tissue or tissue, its objective biosafety evidence;

k) If it is a near disease out of the human body diagnostic equipment, the specific situation of research and test on the human body substance representing the expected user and under similar use conditions;

l) The conclusions of the manufacturer based on the study in paragraph (I);

m) The general description of the manufacturer's study under paragraph (H) and the conclusions thus drawn;

n) Published documents related to the use, safety and effectiveness of the device;

o) Copy of device label;

p) Can / csa-iso 13485:98 certificate issued by an institution accredited by the Canadian medical device certification authority.

After the medical device license is issued, the manufacturer shall submit a re confirmation to the health department of Canada on November 1 every year. Cancellation of the production license shall be made within 30 days of the cessation of Canadian sales.

Administrative measures for registration of medical devices

Regulations on supervision and management of medical devices

Electrical safety regulations

Electromagnetic compatibility regulations

Biocompatibility regulations

Software validation regulations

Time: class I: 3 months, class II: 6 months, class III: 12 months

Cost: class I review fee: 10554; The second category of assessment fee: 21360 yuan, the third category: 34516 yuan

Annual fee: 5326 yuan

Exemption from registration of class I medical devices

Registration of class II devices

Registration of class III devices

Registration of class IV devices

Registration of class IV devices