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FederalDid not become law (session ended)40th Parliament, 2nd Session

Bill S-243 explained in plain English

An Act to establish and maintain a national registry of medical devices

Federal Parliament bill summary, status, timeline, sponsor, votes, and official sources.

At a glance

Jurisdiction
Federal Parliament
Legislature / Parliament
Parliament of Canada
Session
40th Parliament, 2nd Session
Bill number
Bill S-243
Full title
An Act to establish and maintain a national registry of medical devices
Current status
Did not become law (session ended)
Latest event
At second reading in the Senate
Last updated
Nov 24, 2009
Sponsor

Official Parliament of Canada snapshot for 40th Parliament, 2nd Session. MP vote breakdowns appear when the House of Commons publishes a recorded division export for that bill. Senate and House stage details include official debate/sitting links when LEGISinfo publishes them.

Chamber
Parliament of Canada
Current Stage
At second reading in the Senate
Latest Activity
Nov 24, 2009
Sponsor
Plain-language explanation
In plain English (our explanation)

Our plain-language take, written for civic education.

Source: By PoliticalData.ca

AI-assisted, reviewed before publishing
Short Version

Bill S-243 would establish a national registry of medical devices, maintained by the Department of Health, to track implantable and home-use medical devices and notify users of health and safety risks.

What It Means

Bill S-243 proposes to create a Medical Devices Registry—a national database managed by the Department of Health. The registry would collect information about implantable medical devices (devices surgically inserted into the body and staying in place for at least 30 days) and prescribed home-use medical devices (devices used at home for health care). Doctors who insert or supply these devices would be required to submit information to the registry, including the patient's name, date of birth, and address (only with the patient's consent), the device details, and information about the manufacturer. Patients would be notified about the registry and asked for their permission to share their personal information. Medical device manufacturers, importers, and distributors would be required to immediately notify the registry if they learn that a device may pose a health or safety risk. The Registrar (a Department of Health employee) would then contact affected users or their doctors to inform them of the risk. Personal information in the registry would be strictly confidential and could only be shared with the patient's written consent. The Registrar would have the ability to destroy registry records according to regulations. Various details would be set through future government regulations.

What This Bill Does
  • Establishes a Medical Devices Registry within the Department of Health, designated a Registrar to manage it
  • Requires doctors to submit information to the registry when they insert implantable medical devices or supply home-use medical devices
  • Requires doctors to inform patients about the registry and obtain consent before sharing personal information
  • Requires manufacturers, importers, and distributors to immediately notify the registry if they become aware a device may pose health or safety risks
  • Requires the Registrar to contact users or their doctors without delay when a device may pose health or safety risks
  • Protects the confidentiality of patient personal information, which cannot be disclosed without written informed consent
  • Allows the Registrar to destroy registry information according to regulations
  • Permits electronic filing of notices and documents with the registry
  • Allows the Governor in Council to make regulations defining home-use medical devices, prescribing registry information, and establishing exemptions for certain devices
Who Is Affected
  • Patients and users of implantable medical devices (devices surgically inserted into the body and staying for at least 30 days)
  • Patients and users of prescribed home-use medical devices (devices used at home for health care purposes)
  • Medical practitioners who insert implantable devices or supply home-use medical devices
  • Medical device manufacturers
  • Medical device importers
  • Medical device distributors
  • The Department of Health and its Registrar
  • Health care facilities where devices are inserted or supplied
Rights, Duties, Or Obligations
  • Medical practitioners must submit device information to the registry as soon as possible after inserting or supplying a device
  • Medical practitioners must inform patients about the registry and obtain written consent before sharing patient names, dates of birth, and addresses
  • Medical practitioners must submit required information in the form prescribed by regulations
  • Manufacturers, importers, and distributors must immediately notify the registry if they become aware a device may pose health or safety risks
  • The Registrar must notify users or their doctors without delay when a device may pose health or safety risks
  • The Registrar must provide users with information necessary to assess risks to their health or safety
  • The Registrar must keep patient names, dates of birth, and addresses strictly confidential and may not disclose them without written informed consent
  • Patients have the right to be informed of the registry and to consent or refuse to have their personal information shared
Important Dates
  • The Act would come into force on a date to be set by order of the Governor in Council, not later than two years after royal assent (Section 13)
Enforcement Or Penalties
  • The bill text does not specify penalties for doctors, manufacturers, importers, or distributors who fail to submit information or notify the registry of risks
Uncertainties Or Limits
  • The bill text does not specify which home-use medical devices are included; this will be determined by regulations
  • The bill text does not specify what other information may be included in the registry; this will be determined by regulations
  • The bill text does not specify the timeline for the Registrar to contact users, only that it must be 'without delay'
  • The bill text does not specify penalties or enforcement mechanisms for non-compliance by doctors, manufacturers, importers, or distributors
  • The bill text does not specify how long information will be kept in the registry, only that the Registrar may destroy it according to regulations
  • The bill text does not specify the form or method by which the Registrar must contact users about risks, only that contact must be made
  • The specific regulatory details for submitting information, the exact categories of information, and destruction timelines are not provided in the bill text
Laws Or Regulations Affected
Food and Drugs Act
referenced

Medical device is defined by reference to the Food and Drugs Act definition

Source: Section 2 (Definitions)

Regulations under the Medical Devices Registry Act
created

The Governor in Council may make regulations defining home-use medical devices, prescribing registry information and forms, establishing destruction procedures for registry records, and exempting certain devices from the Act

Source: Section 12

Generated using AI from official bill text. Not legal advice. It is written by PoliticalData.ca for civic education, automatically checked and spot-reviewed before publishing.

Official text

Parliamentary Process

Step 1
First reading
Oct 27, 2009
Completed

Bill S-243, to establish a national registry of medical devices, completed its first reading in the Senate on October 27, 2009, and was later debated at second reading.

Introduction and first reading, Oct 27, 2009
End of stage activity, Oct 27, 2009
Chamber sittings
Introduction and first reading - Oct 27, 2009

On October 27, 2009, Bill S-243, concerning a national registry of medical devices, received its first reading in the Senate as part of routine proceedings.

Step 2
Second reading
Nov 24, 2009
Not completed

On November 24, 2009, the Senate began debating the general principles of Bill S-243, an act to create a national registry of medical devices, but the debate was not completed.

Chamber sittings
Debate at second reading - Nov 24, 2009

On November 24, 2009, the Senate held a sitting primarily focused on tributes for Senator John Bryden, with other business including tabling reports, question period, and the adjournment of debate on Bill S-243 (Medical Devices Registry) at its second reading.

The Senate adjourned debate on Bill S-243, An Act to establish and maintain a national registry of medical devices, during its second reading stage.

Step 3
Third reading
Not reached yet
Not reached

We don't have a plain-language summary for Third reading yet. The official source linked below is the full record.

Step 1
First reading
Not reached yet
Not reached

We don't have a plain-language summary for First reading yet. The official source linked below is the full record.

Step 2
Second reading
Not reached yet
Not reached

We don't have a plain-language summary for Second reading yet. The official source linked below is the full record.

Step 3
Consideration in committee
Not reached yet
Not reached

We don't have a plain-language summary for Consideration in committee yet. The official source linked below is the full record.

Step 4
Report stage
Not reached yet
Not reached

We don't have a plain-language summary for Report stage yet. The official source linked below is the full record.

Step 5
Third reading
Not reached yet
Not reached

We don't have a plain-language summary for Third reading yet. The official source linked below is the full record.

Debate and sitting links point to official parliamentary sources when LEGISinfo publishes them. Any plain-language discussion summaries should be generated from those official texts and reviewed before public display.

Vote Summary

No published recorded division

This bill is still active. We only show vote counts after the legislature publishes a recorded division.

Sponsor
Mac Harb
Senator | Details not listed in current Senate roster
Jurisdiction
Federal Parliament

No published representative vote breakdown

This bill is still moving through the process. When a recorded division is published, representative positions can be listed here.

Official sources

Status, sponsor, votes, and timeline on this page are drawn from these official legislative sources and public records. Each summary above is attributed to its own source.

How this data is sourced