Regulatory ESSENTIAL



Regulatory ESSENTIALS - modular information package with all the essential information for compliant products in your target market. Conveniently read online at Product-Compliance-Portal ROGER WILLCO.

INMETRO Certification; Medical Devices; medical devices class i; UDI Code; sterile packaging; clinical evaluation; IMDRF; ISO 15223-1 symbol; vigilance;

Scope: 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 Health products in Canada are classified into four risk classes, according to the risk classification: Class I - low risk Class II - medium risk Class III - high risk Class IV - highest risk Health Canada issues two different types of licences for medical devices: 1.) Medical Device Licence (MDL) – a licence issued to manufacturers authorizing them to import or sell their Class II, III or IV medical devices in Canada. 2.) Medical Device Establishment Licence (MDEL) – a licence issued to Class I manufacturers as well as importers or distributors of all device classes to permit them to import or distribute a medical device in Canada. Not in scope of this CRF (although also regulated by the Food and Drugs Act and CMDR) - In-Vitro Diagnostics (see: ESSENTIAL CAN In-Vitro Diagnostics)

Stakeholders: Manufacturer, Importer, B2C products, B2B products
Legislation in force: This law regulates: Foods, Drugs, Cosmetics and (Medical) Devices. Definition of "DEVICE": device means an instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, part or accessory of any of them, that is manufactured, sold or represented for use in (a) diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings or animals, (b) restoring, modifying or correcting the body structure of human beings or animals or the functioning of any part of the bodies of human beings or animals, (c) diagnosing pregnancy in human beings or animals, (d) caring for human beings or animals during pregnancy or at or after the birth of the offspring, including caring for the offspring, or (e) preventing conception in human beings or animals; however, it does not include such an instrument, apparatus, contrivance or article, or a component, part or accessory of any of them, that does any of the actions referred to in paragraphs (a) to (e) solely by pharmacological, immunological or metabolic means or solely by chemical means in or on the body of a human being or animal; Articles 19 and 20 refer to (Medical) Devices. Article 31 refers to Offences and Punishment Abbreviation of the Canadian Medical Device Regulation: CMDR Art. 2 - Application These Regulations apply to (a) the sale and advertising for sale of a medical device; and (b) the importation of a medical device for sale or for use on individuals, other than importation for personal use. Art.10 - 20 Safety and Effectiveness Requirements Art.21 - 23 Labelling Requirements

Application national:

Countries: Image for CA Canada,  
Status: Published 2024-01-18 by Anette Dunkel-Reinboth and Torsten Sahm
Last change 2024-07-04 by Anette Dunkel-Reinboth: UDI marking , Medical devices
ROGER WILLCO ID: #9e7k
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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

Health products in Canada are classified into four risk classes, according to the risk classification:
Class I - low risk
Class II - medium risk
Class III - high risk
Class IV - highest risk

Health Canada issues two different types of licences for medical devices:
1.) Medical Device Licence (MDL) – a licence issued to manufacturers authorizing them to import or sell their Class II, III or IV medical devices in Canada.
2.) Medical Device Establishment Licence (MDEL) – a licence issued to Class I manufacturers as well as importers or distributors of all device classes to permit them to import or distribute a medical device in Canada.


Not in scope of this ESSENTIAL (although also regulated by the Food and Drugs Act and CMDR)
- In-Vitro Diagnostics (see: ESSENTIAL CAN In-Vitro Diagnostics)'

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 a table

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 a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

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)

Source for standards for conformity assessment
Here you will get textual information

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

Regulatory e-labelling allowed?
Here you will get textual information

e. g. put the regulatory information and labels in a software menu

UDI marking
Here you will get textual information

Required information on the product and/or packaging
Here you will get textual information

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 related hyperlink(s)

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, ContinentCAN, America
Economic AreaAPEC
Official LanguageEnglish; 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 InstituteStandards Council of Canada (SCC) | https://www.scc.ca/ Canadian Standards Association (CSA) |https://www.csagroup.org/
HS CodememberYes






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