Bill S-202 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
Official Parliament of Canada snapshot for 41st Parliament, 1st 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.
Our plain-language take, written for civic education.
Source: By PoliticalData.ca
Bill S-202 establishes a national Medical Devices Registry in Canada to collect information about implantable and prescribed home-use medical devices with user consent, and requires manufacturers and medical practitioners to notify users of health and safety risks.
Bill S-202 creates a Medical Devices Registry that would be established and maintained by the Canadian Department of Health. The Registry is designed to track implantable medical devices (devices surgically inserted into the body for at least 30 days) and prescribed home-use medical devices with the consent of users. Doctors who insert implantable devices or supply home-use devices must submit information to the Registry, including the patient's name, address, date of birth, the device details, manufacturer information, and serial or lot numbers. Patients must consent before their personal information is shared. The bill requires manufacturers, importers, and distributors to immediately notify the Registry if they become aware a device may pose a health or safety risk to users. When a risk is identified, the Registrar must contact affected users to inform them, either directly (if their information is in the Registry) or through their doctor (if information was not submitted). Personal information in the Registry is confidential and cannot be disclosed without the user's written, informed consent. The Registry can be maintained electronically. The bill also amends the Access to Information Act to add the Medical Devices Registry Act to Schedule II, which affects how access to information requests are handled. The Minister may make regulations to specify which home-use devices must be registered, what additional information to collect, how information may be destroyed, and whether to exempt certain devices from the Act. The bill comes into force no later than two years after receiving royal assent.
- Establishes a Medical Devices Registry within the Department of Health to track implantable and prescribed home-use medical devices (section 4)
- Designates a Registrar of Medical Devices from Department of Health employees to manage the Registry (section 3)
- Requires doctors to submit information about implantable devices and home-use devices to the Registry, including patient name, address, date of birth, device details, and manufacturer information, with patient consent (section 5)
- Requires doctors to inform patients about the Registry and obtain their consent before submitting personal information (section 5(2))
- Requires the Registrar to send registered patients a copy of their information and advise them to notify the Registrar of address changes (section 6)
- Requires manufacturers, importers, and distributors to immediately notify the Registrar when they become aware a device may pose a health or safety risk (section 7)
- Requires the Registrar to contact affected users or their doctors without delay when a device may pose a health or safety risk (section 8)
- Prohibits disclosure of patient names and addresses from the Registry without written, informed consent of the patient (section 11)
- Allows the Registrar to maintain the Registry in electronic or other forms as prescribed (section 9 and 10)
- Allows the Registrar to destroy Registry information at times and in circumstances prescribed by regulations (section 4(3))
- Amends Schedule II to the Access to Information Act to add the Medical Devices Registry Act and reference section 11 (section 13)
- Authorizes the Governor in Council to make regulations to carry out the Act's purposes, including prescribing types of home-use devices, information to collect, information destruction procedures, and exemptions (section 12)
- People who use implantable medical devices (devices surgically inserted into the body and expected to remain for at least 30 days)
- People who use prescribed home-use medical devices (specific types of medical devices prescribed by regulations for home use related to health care)
- Medical doctors and practitioners who insert implantable devices or supply home-use devices (they must submit information to the Registry)
- Manufacturers, importers, and distributors of implantable and home-use medical devices (they must report devices that may pose health or safety risks)
- The Department of Health and the designated Registrar of Medical Devices (responsible for establishing and managing the Registry)
- Government agencies seeking access to patient information held in the Registry (subject to patient consent requirements)
- Medical practitioners must submit information about implantable and home-use devices to the Registrar as soon as possible after insertion or supply (section 5(1))
- Medical practitioners must inform patients about the Registry and obtain consent before submitting personal information (section 5(2))
- Manufacturers, importers, and distributors must immediately notify the Registrar when they become aware a device may pose a health or safety risk (section 7)
- The Registrar must establish and maintain the Registry within the Department of Health (section 4(1))
- The Registrar must send registered patients a copy of their information and notice about address changes (section 6)
- The Registrar must contact users or doctors without delay when a device may pose a health or safety risk and provide relevant risk information (section 8)
- Patients have the right to consent to or refuse disclosure of their personal information to the Registry (section 5(1)(a))
- Patient personal information in the Registry cannot be disclosed without the patient's written, informed consent (section 11)
- The Registrar may destroy information from the Registry at times and in circumstances prescribed by regulations (section 4(3))
- The Act comes into force no later than two years after receiving royal assent, on a date to be fixed by order of the Governor in Council (section 14)
- The bill does not specify penalties or enforcement mechanisms for manufacturers, importers, distributors, or doctors who fail to comply with the requirements.
- The specific types of 'home-use medical devices' that must be registered are not defined in the bill; they will be prescribed by regulation.
- The bill does not specify what happens to information if a user withdraws consent for participation in the Registry.
- The exact timing of when the Act comes into force is not specified; it will be set by Governor in Council order within two years of royal assent.
- The bill does not specify how the Registrar will communicate with users in all scenarios (e.g., if contact information changes or is incomplete).
- The bill authorizes but does not mandate regulations; it is unclear which specific regulations will be made and when.
- The bill does not address international or cross-border scenarios for devices imported into Canada.
Schedule II of the Access to Information Act is amended to add a reference to the Medical Devices Registry Act and section 11, meaning the Registry's confidentiality protections for patient personal information will be subject to federal access to information procedures.
Source: Section 13
The bill defines 'medical device' by reference to the Food and Drugs Act, meaning the same definition of medical device used in that Act applies for purposes of this Registry.
Source: Section 2, definition of 'medical device'
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 textParliamentary Process
Bill S-202, proposing a national registry for medical devices, completed its first reading in the Senate on June 14, 2011, and has since moved through further procedural stages.
This record indicates that Bill S-202, concerning the establishment and maintenance of a national registry for medical devices, completed its first reading in the Senate on June 14, 2011. This is a procedural step where a bill is formally introduced. The record also lists subsequent procedural stages the bill has undergone, including second reading, committee study, and report stage, as well as dates for related speeches.
In a Senate sitting on June 14, 2011, a new senator was sworn in, and Bill S-202, concerning a national registry of medical devices, received its first reading.
On June 14, 2011, the Senate held a sitting where a new senator, Josée Verner, was introduced and sworn in. The Senate also proceeded with routine matters, including the tabling of various reports and the introduction of Bill S-202, "An Act to establish and maintain a national registry of medical devices," which received its first reading. Several notices of motions were given regarding committee meetings and the study of other bills. The sitting also included question period and continuation of debate on other matters before the Senate.
Bill S-202, concerning a national registry of medical devices, completed its second reading in the Senate in 2011 and proceeded through committee and report stages in 2013.
This record outlines the progression of Bill S-202 through the Senate. It details that the bill reached its second reading stage on October 19, 2011, with major speeches occurring on November 2, 2011. The process also shows the bill went through consideration in committee and report stage in 2013. The bill's current status is reported as being at the report stage in the Senate.
During a Senate sitting on October 19, 2011, various statements, proceedings, and questions were addressed, and the second reading debate for Bill S-202, concerning a national registry of medical devices, was adjourned.
On October 19, 2011, the Senate of Canada convened for a sitting that included SENATORS' STATEMENTS on topics such as mental illness awareness, the Nobel Peace Prize, drug treatment programs, the Mackenzie Gas Project, and tributes to Captain Joshua Slocum, Lewis MacKinnon, and the Ukrainian Shumka Dancers. The ROUTINE PROCEEDINGS involved tabling a report on Senators' property qualifications and a notice of motion to study grey seal populations. QUESTION PERIOD addressed opportunities for Aboriginal youth, recruitment levels in the military, and issues concerning Aboriginal women in prison and juvenile offenders. The ORDERS OF THE DAY included continuing debate on the Federal Law—Civil Law Harmonization Bill, No. 3, and adjourning debate on the World Autism Awareness Day Bill. Notably, Bill S-202, concerning a national registry of medical devices, had its second reading debate adjourned.
During the Senate's second reading debate on October 19, 2011, Senator Mac Harb sponsored Bill S-202, an Act to establish and maintain a national registry of medical devices, highlighting the need for improved patient safety and notification in case of device failures, after which the debate was adjourned.
This artifact is a record of the Senate debate on Bill S-202, an Act to establish and maintain a national registry of medical devices, during its second reading on October 19, 2011. Senator Mac Harb introduced the bill and spoke in favour of its second reading. He explained that the bill aims to create a registry of individuals using certain medical devices to improve patient safety and facilitate notification in case of device recalls or malfunctions. The debate also included discussions on other bills and various Senate business, but the core procedural event related to Bill S-202 was its second reading debate, which was subsequently adjourned.
During a Senate sitting on November 2, 2011, debate on Bill S-202, concerning a national medical device registry, continued and the bill was referred to committee.
This document is a record of a Senate sitting on November 2, 2011. The sitting included Senators' Statements, Routine Proceedings, Question Period, and Orders of the Day. During Orders of the Day, the Senate continued the debate on Bill S-202, which aims to establish a national registry of medical devices, and referred it to committee. Other items discussed included the Railway Safety Act, various committee reports and budgets, and several inquiries and motions.
During a Senate debate, a discussion on Bill S-202, An Act to establish and maintain a national registry of medical devices, occurred where concerns about jurisdiction, privacy, and costs were raised by one senator, while another senator spoke in favour of further study due to personal experience, ultimately leading to the bill passing second reading "on division" and being sent to committee.
This Senate debate record from November 2, 2011, primarily covers discussions unrelated to Bill S-202. The core of the record includes several senators' statements on various topics like a technology mentoring program, the long-gun registry, an award received by Senator Céline Hervieux-Payette, Veterans' Week, and the 75th anniversary of CBC/Radio-Canada. It also details routine proceedings, question period exchanges on poverty, missing Indigenous women, water supply on reserves, and support for Edmonton's bid to host a World Fair. Later in the proceedings, there is a debate about Bill S-4, the Safer Railways Bill, which was read a second time and referred to committee. Finally, the record details the continuation of the debate on Bill S-202, An Act to establish and maintain a national registry of medical devices. During this debate, Senator Judith Seidman expressed concerns about federal jurisdiction, privacy, and costs associated with the bill, stating the government does not support it. Senator Terry M. Mercer declared a conflict of interest due to personal experience with medical implants and spoke in favour of sending the bill to committee for further study, referencing a positive discussion with his surgeon and a registry in New Zealand. The bill was read a second time, "on division," and referred to committee.
The Senate committee's examination of Bill S-202, an act to create a national registry for medical devices, was completed on April 30, 2013.
This artifact details the procedural progress of Bill S-202 in the Senate. Specifically, it marks the completion of the 'Senate Consideration in committee' stage on April 30, 2013. This means the Senate committee examined the bill and completed its work on it. The record also lists subsequent stages like report stage and provides historical context by showing previous stages such as first and second reading, along with related bills from past parliamentary sessions that aimed to establish a national registry of medical devices.
The Senate's Social Affairs, Science and Technology Committee recommended against proceeding with Bill S-202, citing concerns about cost, privacy, and existing regulations.
On April 30, 2013, the Senate considered committee reports. The Standing Senate Committee on Social Affairs, Science and Technology presented its twenty-third report, recommending that Bill S-202, An Act to establish and maintain a national registry of medical devices, not be proceeded with further. The committee cited concerns about existing Health Canada authority, rigorous pre-market evaluations, privacy risks, and significant costs outweighing benefits as reasons for its recommendation. The committee suggested a comprehensive national integrated electronic health records system as an alternative.
Bill S-202, aiming to create a national medical device registry, was at the report stage in the Senate as of June 18, 2013, with this stage not yet completed.
The Senate was in the process of the report stage for Bill S-202, an act to establish a national registry for medical devices. The report stage had not been completed as of June 18, 2013. This stage follows consideration of the bill by a committee. The provided text outlines the bill's progression through various stages, including first reading, second reading, committee study, and report stage, with dates for each.
The Senate debated Bill S-202, concerning a national medical device registry, where the Social Affairs Committee recommended not proceeding with the bill due to cost, privacy, and effectiveness concerns.
On May 1, 2013, the Senate of Canada met. During the sitting, the Senate debated Bill S-202, which aims to establish a national registry of medical devices. The Standing Senate Committee on Social Affairs, Science and Technology recommended that the Senate not proceed with the bill, citing concerns about cost, privacy, and the effectiveness of a voluntary registry compared to existing regulations. The debate focused on these concerns, with senators discussing the adequacy of current Health Canada regulations, the privacy implications of collecting patient data, and the financial burden on taxpayers. The debate on Bill S-202 was adjourned.
During a Senate sitting on June 18, 2013, various legislative matters were discussed, including the adjournment of debate on Bill S-202 regarding a medical devices registry, alongside other committee reports and inquiries.
This Senate sitting on June 18, 2013, included several discussions and procedural actions. Notably, Bill S-202, concerning a national registry of medical devices, was debated. Senators also discussed reports on the Royal Canadian Mounted Police's culture, the Proceeds of Crime (Money Laundering) and Terrorist Financing Act, and various other bills and inquiries. The sitting also featured statements on the War of 1812, the Gimli Glider incident, sexual violence against women, Korean War veterans, and mandatory reporting standards for extractive companies. Questions were raised regarding Senate motivational speakers, the role of employees in political offices, job creation for First Nations, and international tax evasion. The discussion on Bill S-202 was adjourned to a later date.
We don't have a plain-language summary for Third reading yet. The official source linked below is the full record.
We don't have a plain-language summary for First reading yet. The official source linked below is the full record.
We don't have a plain-language summary for Second reading yet. The official source linked below is the full record.
We don't have a plain-language summary for Consideration in committee yet. The official source linked below is the full record.
We don't have a plain-language summary for Report stage yet. The official source linked below is the full record.
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
This bill is still active. We only show vote counts after the legislature publishes a recorded division.
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