regulatory

Medical Device Classification

The registration requirements for the products and requirements for compliance of manufacturer vary greatly depending on the classification of medical device classifications. Therefore, it is extremely important to first properly classify your product. If confirmed that your product is indeed a medical device in accordance with the Canadian classification system, Atinza will support to classify your medical devices according to the risk of your device to determine it belongs to class I, II, III or IV.

Health Canada’s definitions for medical devices and corresponding device class may not be the same as in other countries. Properly classify your medical device from the very beginning will save you cost, time and effort. We aim to avoid unnecessary delays with Canadian regulatory authorities for you and your products and ultimately save your product’s time to market.Read More

Premarket Review Document

All Class III and Class IV medical devices will require a scientific and medical review of submitted evidence of safety and effectiveness before their licence applications can be finalized. Approximately two thirds of medical devices in Canada will undergo some form of premarket scrutiny before sale.

The technical documentation required for premarket conformity assessment is extracted from the complete set of on-site quality systems records, including design input requirements, design output documentation, verification and validation documents and production and process documents.

A new licence application for a Class III or a Class IV medical device will contain a premarket review document in addition to the general requirements of medical device submissions.Read More

TECHNICAL LABEL REVIEW

Atinza will work closely with clients to ensure label of medical devices will comply strictly with the labeling requirements pursuant to labeling requirements under sections 21 – 23 of the Medical Devices Regulations. We will also advise clients relating requirements in other relevant Health Canada guidelines, policies and technical documents.

Specific labeling requirements is applied for non-in vitro diagnostic devices and in vitro diagnostic devices, custom-made or offered under special access or investigational testing provisions.

In vitro diagnostic devices can be found in Guidance for the Labeling of In Vitro Diagnostic Devices.

Custom-made or offered under special access devices should follow instructions for Custom- made Devices and Medical Devices for Special Access.

Medical Devices approval process in Canada

For Class I devices, submit MDEL application.

For Class II devices, Submit MDL application, Fee Form, labeling, Declaration of Conformity and ISO 13485 certificate.

For Class III and IV devices, submit MDL application plus Declaration of Conformity, ISO 13485 certificate, labeling and Premarket Review Document which may include the requirement for clinical data.

Health Canada will review applications and issue approval if the application meet requirements.

Approval for medical devices do not expire if the registration is renewed promptly and annual fee is paid to Health Canada on time. Failure to file renewal and pay fees by the annual deadlines will result in license(s) being revoked.Read More

Medical Device Establishment License

Atinza can support clients in preparation and filing of a Medical Device Establishment License (MDEL) application. If it is determined that as part of your MDEL signed attestation, additional assistance is needed to achieve the required level of procedural compliance, we will work with clients to assure all needed procedures are properly established and implemented.

View all our services

MDEL & MDL

Class I medical devices or IVDs and plan to sell directly into Canada without a distributor must secure a Medical Device Establishment License (MDEL). If selling through distributors in Canada, the distributor will need a MDEL. Medical device distributors and importers must secure an MDEL regardless of device classifications.

Medical Device License (MDL) is required for companies selling Class II, III, or IV medical devices in Canada. The MDL is a product approval, while MDEL is a permit required for the company/distributor/importer.

ISO 13485 Quality Management System

Quality system compliance to the ISO 13485 standard is required by Health Canada for manufacturer of medical devices.

Manufacturers of medical devices classified as Class II, III, and IV must also comply with Canadian Medical Devices Regulations (CMDR). Certification of your CMDR-compliant quality system by a Health Canada accredited registrar is also required before your medical device can be sold in Canada.

Atinza will support clients to Quality Management System (QMS) compliance to ISO 13485 and Health Canada CMDR.

Our support for medical device registration

We assist clients in determining your device classification in Canada.
We complete and file Canadian Medical Device License (MDL) or Medical Device Establishment License (MDEL) application on your behalf.
Developing, implementing or modifying your ISO 13485 quality management system to meet Canadian requirements.
Audit onsite to ensure compliance with ISO 13485:2003 and CMDR.