Collection search - Bureau of Medical Devices [textual record (microform)]

Record information – Brief
1
Bureau of Medical Devices [textual record (microform)]

Hierarchical level:

Sub-series

Date:

1975-1993

Reference:

R227-86-9-E, RG29-71

Type of material:

Textual material

Found in:

Archives / Collections and Fonds

Item ID number:

193660

Context of this record:

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Department of Health fonds

Health Protection Branch sous-fonds

Environmental Health Directorate

Bureau of Medical Devices
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Record information – Details
Date(s):

1975-1993

Bilingual equivalent:

Click here

Place of creation:

Canada

Extent:

365 microfilm reels of textual records

Language of material:

English
Accession:

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Submissions from divice manufacturers to the Bureau of Radiation and Medical Devices [textual record]

Medical Devices Part V Submissions 1982-1993 [textual record]

Operational Records of the Health Protection Branch, Bureau of Medical Devices [textual record]
Scope and content:

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Sub-series consists of Bureau of Medical Devices registry files from the 9680 block. The microfilm reels contain notifications under parts I through IV of the Regulations and amendments to certain notifications.

Additional name(s):

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Canada. Bureau of Medical Devices

Biography/Administrative history:

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Canada. Bureau of Medical Devices : The Food and Drug Act, passed in 1920, was intended to protect Canadians from adulterated foods, drinks or drugs; its administration was carried out by the Food and Drug Directorate, which was created in 1946. In 1953, a revised Food and Drug Act was passed, giving specific definitions and requirements for food, drugs, cosmetics and medical devices.

The Bureau of Medical Devices was created in April 1974 to ensure that manufacturers adhere to the provisions of the Act which prohibit the sale of medical devices which could be hazardous to the health of Canadians, are packaged in a misleading fashion, claim to cure diseases such as cancer, or fail to meet established standards. To implement those provisions, the Bureau administers a five part Medical Device Regulations and monitors the labelling, testing, inspection, notification of sale, safety and sometimes recall of all devices (parts I-IV). Part V of the Regulations deals with the sale of products which have not been sold in Canada before, and are extended-wear contact lenses, menstrual tampons, or devices intended to be inserted into the body for a period of more than 30 days. While all of the devices under parts I through IV require only a notification of the intent to sell, manufacturers of devices under Part V must submit a satisfactory package of information to the Bureau in order to receive a Notice of Compliance, which makes the sale of the device legal in Canada.

Finding aid:

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(Paper) Finding aid 29-14 is a typed content map. Some restrictions apply. 29-136

Additional information:

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Source of title:

Title is based on the contents of the sub-series.

Accruals:

Further accruals are expected.

Container note(s):

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T-13392 : Copy No. 1
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T-8697 : SP
T-14326 : SP

Source:

Government

Related control no.:

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116-000013-5
117-000098-2
121-000442-9
123-000637-0
123-000638-9
1987-01-389 OFRC
1988-89/013 GAD
1989-90/098 GAD
1993-94/442 GAD
1995-96/637 GAD
1995-96/638 GAD
1997-03-009 OFRC
2013-00283-1
2013-00284-X
M-7-82
R227
RG29

Former archival reference no.:

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RG29-71
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Conditions of access:

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Textual records: microform

[Consultation96 Restrictions vary]

Microfilm reel [RG29]

[Consultation 32 Restricted by law]

T-13392--T-13439;

[Consultation 32 Restricted by law]

T-14300--T-14348;

[Consultation 32 Restricted by law]

T-8697--T-8964;

[Consultation 32 Restricted by law]

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Date modified:: 2024-07-04