Scope of this ESSENTIAL

This ESSENTIAL describes the regulatory requirements of medical devices in Canada, based on - Food and Drugs Act - Canadian Medical Devices Regulations (SOR/98-282) - abbreviated: CMDR - Health Canada Guidance Documents IVDDs are grouped into the following four risk classes based on the degree of risk associated with the use of an IVDD: Class I - low risk Class II - medium risk Class III - high risk Class IV - highest risk Not in scope of this ESSENTIAL (although also regulated by the Food and Drugs Act and CMDR) - Medical Devices (see: ESSENTIAL CAN Medical Devices) The item "Device" is used according the Food and Drugs Act and the CMDR includes IVD products.'

Analysis of regulatory requirements

Legislation in force for this PCT

Here you will get a linked document in ROGER WILLCO (only reachable with additional ROGER WILLCO license) Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Responsible actors

Here you will get textual information Which actor(s) are responsible for compliance with the legal provisions: e. g. - economic operators (manufacturer, importer, distributor, fulfilment service provider), - user (commercial/industrial/professional), - user (private, consumer)?

Regulatory market access conditions for the actor(s)

Here you will get textual information What are the main regulatory requirements (e. g. conformity assessment fulfilment of essential requirements of Annex I 2006/42/EC) prior placing on the market, importation and putting into service (brief description)

Exemption clauses

Here you will get textual information Exempted devices/products or industry sectors.

Sub-federal legislation of states/counties

Here you will get textual information E. g. by 2019 an Inter-Governmental Agreement (IGA) on governance of the Electrical Equipment Safety System (EESS) has been signed by Queensland, Victoria, Western Australia and Tasmania.

FTA/MRA status with EU

Here you will get a linked document in ROGER WILLCO (only reachable with additional ROGER WILLCO license) Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?

Authority

Here you will get related hyperlink(s) Name of the authority for approval, registration, market surveillance and/or enforcement

Link/Reference to other reference document(s)

Here you will get related hyperlink(s)

Abbreviations

Here you will get textual information Important abbreviations which are special for this legislation or theme.

Route to compliance

Formal and administrative requirements

Registration at related authority required?

Here you will get textual information Product registration? Manufacturer registration? Importer / Representative registration? if required.

Local representative legally required?

Here you will get textual information [Yes/No]

IMDRF Membership

Here you will get textual information Established in October 2011, the IMDRF is a forum for medical device regulators from multiple jurisdictions who have agreed to work together to promote international harmonization and convergence in the medical device field. The IMDRF builds on the foundational work of the Global Harmonization Task Force (GHTF), which was established in 1992 with the EU as one of the founding members.

Database Entry required

Here you will get textual information

Hints

Here you will get related hyperlink(s) Specific recommendations, information or most common mistakes

Equipment authorization (approval process)

Classification Rules

Here you will get related hyperlink(s)

Approval process (conformity assessment procedure)

Here you will get related hyperlink(s) Means each legally required approval process prior placing on the market, importation or putting into service

Approval process (conformity assessment procedure)

Here you will get a image or chart Means each legally required approval process prior placing on the market, importation or putting into service

Approval process (conformity assessment procedure)

Here you will get a table Means each legally required approval process prior placing on the market, importation or putting into service

Conformance document(s) to show compliance to the authority

Here you will get a table e. g. SDoC, technical documentation (for 10 years), filled-in approval forms (e. g. ACMA in AUT)

Conformance document(s) to show compliance to the authority

Here you will get related hyperlink(s) e. g. SDoC, technical documentation (for 10 years), filled-in approval forms (e. g. ACMA in AUT)

Which documents are required by an approval body?

Here you will get textual information e .g. formal application

Is a factory inspection legally required

Here you will get textual information

Testing & Standards

General information to the application of standards

Here you will get related hyperlink(s) e. g. China: GB standards are mandatory, EU: harmonized standards shall be published in the OJEU with respect to "presumption of conformity"

Source for standards for conformity assessment

Here you will get related hyperlink(s)

Clinical Investigation/Evaluation

Here you will get related hyperlink(s)

Is in-country testing legally required?

Here you will get textual information

Acceptance of foreign test reports

Here you will get textual information

Regulatory labelling, markings and user information

Regulatory label (mandatory)

Here you will get textual information e. g. product label

UDI marking

Here you will get textual information

Regulatory e-labelling allowed?

Here you will get textual information e. g. put the regulatory information and labels in a software menu

Required information on the product and/or packaging

Here you will get related hyperlink(s) e. g. address of the manufacturer/importer, serial number

User instructions language(s)

Here you will get textual information Regulated by the legal provisions

User instruction requirements and specific compliance notes

Here you will get textual information Form, sentence inside, simple text. E. g. FCC/ISED compliance information, SAR information, battery, environmental information like waste

Medical Device Symbols

Here you will get textual information

Code, Continent	CAN, America
Economic Area	APEC
Official Language	English; French - Official Languages Act (R.S.C., 1985, c. 31 (4th Supp.)) | https://laws-lois.justice.gc.ca/eng/acts/o-3.01/fulltext.html
Standard Institute	Standards Council of Canada (SCC) | https://www.scc.ca/ Canadian Standards Association (CSA) |https://www.csagroup.org/
HS Codemember	Yes