S-243
Second Session, Fortieth Parliament,
57-58 Elizabeth II, 2009
SENATE OF CANADA
BILL S-243
An Act to establish and maintain a national registry of medical devices
first reading, October 27, 2009
THE HONOURABLE SENATOR HARB
3810432
SUMMARY
This enactment requires the Registrar of Medical Devices, designated by the Minister of Health, to establish and maintain a Medical Devices Registry. The Registry will contain, with their consent, the names and addresses of persons who use implantable medical devices or prescribed home-use medical devices, a description of the medical devices and other information. Personal information in the Registry may not be disclosed for any purpose without the person’s written and informed consent.
The enactment requires the manufacturers, importers and distributors of these medical devices to notify the Registrar if they become aware that a medical device may pose a risk to the health or safety of the user. The Registrar is required to notify registered users if a medical device may pose a risk to their health or safety.
Available on the Parliament of Canada Web Site at the following address:http://www.parl.gc.ca
2nd Session, 40th Parliament,
57-58 Elizabeth II, 2009
senate of canada
BILL S-243
An Act to establish and maintain a national registry of medical devices
Preamble
Whereas medical device problem reporting is an essential element in the continued efforts of the Health Products and Food Branch Inspectorate of the Department of Health to protect the health and safety of Canadians;
And whereas, although manufacturers and importers are required to report certain medical device problems, the Parliament of Canada acknowledges that a complementary medical device problem notification system should be maintained by the Department of Health;
Now, therefore, Her Majesty, by and with the advice and consent of the Senate and House of Commons of Canada, enacts as follows:
SHORT TITLE
Short title
1. This Act may be cited as the Medical Devices Registry Act.
INTERPRETATION
Definitions
2. The following definitions apply in this Act.
“home-use medical device”« instrument médical pour usage à domicile »
“home-use medical device” means a medical device
(a) intended to be used by a person in a home environment for purposes related to their health care; and
(b) of a kind prescribed by the regulations.
“implantable medical device”« instrument médical implantable »
“implantable medical device” means a medical device that
(a) is partly or totally inserted into the human body or a natural orifice by means of a surgical or medical procedure;
(b) is expected to stay there for 30 days or more; and
(c) would require a surgical or medical procedure to remove it.
“manufacturer”« fabricant »
“manufacturer” means a person who sells a medical device under their own name, or under a trade-mark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf.
“medical device”« instrument médical »
“medical device” means a device within the meaning of the Food and Drugs Act.
“medical practioner”« médecin »
“medical practioner” means a person lawfully entitled to practise medicine in the place in which the practice is carried on by that person.
“Minister”« ministre »
“Minister” means the Minister of Health.
“Registrar”« directeur »
“Registrar” means the Registrar of Medical Devices designated under section 3.
“Registry”« Registre »
“Registry” means the Medical Devices Registry established under subsection 4(1).
“supply”« fournir »
“supply” in relation to a medical device, includes to issue a prescription that authorizes a person to obtain a medical device.
“user”« utilisateur »
“user” means a person who has had an implantable medical device inserted into their body or who uses a home-use medical device supplied to them by a medical practitioner.
MEDICAL DEVICES REGISTRATION SYSTEM
Registrar of Medical Devices
Designation of Registrar of Medical Devices
3. The Minister shall designate a person, from among persons employed in the Department of Health, as the Registrar of Medical Devices.
Medical Devices Registry
4. (1) The Registrar shall establish and maintain, within the Department of Health, a registry, to be called the Medical Devices Registry, containing
(a) the information submitted by medical practitioners under subsection 5(1);
(b) a record of any information provided by the manufacturer, importer or distributor of a medical device that identifies any risk to the health or safety of the user; and
(c) any other information prescribed by the regulations.
Operation
(2) The Registrar is responsible for the day-to-day operation of the Registry.
Destruction of information
(3) The Registrar may destroy information kept in the Registry at the times and in the circumstances that may be prescribed by the regulations.
Reporting and Notification
Submission of information by medical practitioner
5. (1) A medical practitioner who inserts an implantable medical device into a person’s body or who supplies a home-use medical device to a person shall, as soon as possible after doing so, submit to the Registrar, in the form prescribed by the regulations, the following information:
(a) the name, date of birth and address of the person, if the person consents to the disclosure of the information;
(b) the medical practitioner’s name;
(c) the date on which, and the health care facility at which, the device was inserted or supplied;
(d) the name and address of the manufacturer of the device;
(e) the model designation of the device, if applicable;
(f) the lot or serial number of the device; and
(g) any other information prescribed by the regulations.
Information and consent
(2) A medical practitioner who inserts an implantable medical device into a person’s body or who supplies a home-use medical device to a person shall
(a) inform the person of the nature and purpose of the Registry and the requirement to submit information to the Registrar; and
(b) seek the consent of the person to the disclosure to the Registrar of the information referred to in paragraph (1)(a).
Change of address
6. The Registrar shall, on receipt of information submitted under subsection 5(1) that includes the name and address of the person in respect of whom the information is submitted, provide to the person a copy of the information and a statement advising the person to notify the Registrar of any change in the person’s permanent address.
Duty of manufacturers, distributors and importers
7. A manufacturer, importer or distributor of an implantable medical device or a home-use medical device shall notify the Registrar immediately after becoming aware that the device may pose a risk to the health or safety of the user, and shall provide the Registrar with the information prescribed by the regulations.
Duty to notify users of risk
8. (1) When the Registrar receives a notification under section 7 or otherwise has reasonable grounds to believe that an implantable medical device or a home-use medical device may pose a risk to the health or safety of the user, the Registrar shall contact without delay
(a) each user of the device whose name and address is listed in the Registry; or
(b) in respect of each device for which the name and address of the user was not submitted to the Registrar, the medical practitioner who registered the device.
Information to be provided
(2) When the Registrar contacts a person under subsection (1), the Registrar shall provide to the person any information that the Registrar considers necessary to assist the person in assessing the risk to the health or safety of the user.
Electronic Filing
Electronic filing
9. Subject to the regulations, any notices and documents that are sent to or issued by the Registrar under this or any other Act of Parliament may be sent or issued in electronic or other form in any manner specified by the Registrar.
Organization of Registry
10. (1) The Registry shall be organized in the manner and kept in the form determined by the Registrar.
Probative value
(2) Where the Registrar maintains a record of a document otherwise than in written or printed form, an extract from that record that is certified by the Registrar has the same probative value as the document would have had if it had been proved in the ordinary way.
Confidentiality
Prohibited disclosure of name and address of user
11. Information described in paragraph 5(1)(a) that is contained in the Registry is confidential, and the Registrar shall not disclose the information to anyone, including an agency of the Crown, without the written consent of the person to whom the information relates, given after the person has been informed of the purpose for which the consent is sought.
REGULATIONS
Regulations
12. The Governor in Council may, on the recommendation of the Minister, make regulations for carrying out the purposes and provisions of this Act, including regulations
(a) for the purposes of the definition “home-use medical device”, prescribing any kind of medical device intended to be used by a person in a home environment for purposes related to their health care;
(b) prescribing information to be contained in the Registry for the purposes of paragraph 4(1)(c);
(c) respecting the destruction of information kept in the Registry for the purposes of subsection 4(3);
(d) respecting information to be submitted by a medical practitioner for the purposes of subsection 5(1);
(e) respecting information to be provided by manufacturers, importers and distributors for the purposes of section 7; and
(f) exempting any medical device, or type of medical device, from the application of this Act if the Minister is of the opinion that the exemption is in the public interest and consistent with public health and safety.
COMING INTO FORCE
Coming into force
13. This Act comes into force on a day, not later than two years after the day on which it receives royal assent, to be fixed by order of the Governor in Council.
Published under authority of the Senate of CanadaAvailable from:Publishing and Depository ServicesPublic Works and Government Services Canada