Medical Device Registration in Canada: Regulatory Compliance and Vigilance

Regulatory Authority

Health Canada, Health Products and Food Branch, Therapeutic Products Directorate, Medical Devices Bureau

The Medical Devices Directorate (MDD) is the national authority that monitors and evaluates the safety, effectiveness and quality of diagnostic and therapeutic medical devices in Canada.

MDD ensures that medical devices sold in Canada meet safety, effectiveness and quality requirements. This is done by a combination of pre-market review, post-approval surveillance and quality systems in the manufacturing process.

Link for Regulatory Authority

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html

Local Regulation

• Food and Drugs Act (R.S.C., 1985, c. F-27)
• Medical Devices Regulations (SOR/98-282)

What is Medical Device?

The term “medical device” covers a wide range of medical instruments used to treat, reduce, diagnose or prevent a disease or abnormal physical condition. Some examples include:

• hip implants
• pacemakers
• synthetic skin
• artificial heart valves
• test kits for diagnosis
• contraceptive devices
• medical laboratory diagnostic instruments

Classification of Medical Devices

Class I, II, III, IV

Listing or Registration Requirements

There are two pathways for medical device registration in Canada:

1. Medical Device Establishment License (MDEL): Class I devices can apply for Medical Device Establishment License Canada (MDEL) by preparing mandatory procedures and paying Health Canada fees.
2. Medical Device License (MDL): Class II, III, and IV devices shall apply for a Canadian Medical Device License (MDL) application. The document requirements for each of the device classes vary.

Process to Register Canada Medical Device

• Device classification
• Class I – Establish QMS procedures → MDEL Application
• Class II, III, IV – MDSAP Certification → MDL Application
• Technical file Evaluation
• Approval

Documents Required for Canada Medical Device Registration

• Depends on class of device
• Manufacturers in Canada must obtain MDSAP certification

Class I

• MDEL application
• QMS procedures
• MDSAP not required for Class I

Class II

• MDL application
• Fee form
• Labeling documents
• Declaration of Conformity (Doc)
• MDSAP certificate

Class III

• MDL application
• Declaration of Conformity (Doc)
• ISO 13485:2016 certificate with MDSAP certificate
• Labeling
• Technical files as per IMRDF

Class IV

• MDL application
• Declaration of Conformity (Doc)
• ISO 13485:2016 certificate with MDSAP certificate
• Labeling
• Technical files as per IMRDF

Registration Timeline

• Class I – MDEL: 120 calendar days.
• MDL:
  • Class II:15 calendar days
  • Class III and IV: Approximately 4-8 months

 Class II license applications: 15 calendar days

 Class III license applications: 75 calendar days

 Class IV license applications: 90 calendar days

Registration Fee

• MDEL: $4,581
• MDL:
  • Class II – $478
  • Class III: $8,895
  • Class III(IVD): $16,032
  • Class IV: $24,699
• Annual fees: 381 Applies to Class II, III, and IV devices

License Validity

1 year

• Both MDELs and MDLs must be renewed annually, otherwise they will be cancelled.
• The MDEL renewal (class I) is done by sending the Annual Review application and paying the fees by April 1st.
• The MDL renewal (classes II, III and IV) is done by declaring the quantity of sold devices, upon which the fee to be paid for renewal is calculated, due by November 1st of each year.

Special Labelling Requirements

Labelled in either English or French.

Pharmacovigilance

In Canada, maintaining a pharmacovigilance system is imperative to ensure the ongoing monitoring of medicinal products and medical devices, guaranteeing their safe use. Health Canada oversees the Canada Vigilance Program, a robust pharmacovigilance initiative responsible for collecting and evaluating adverse drug reaction reports related to health products. 

Individuals, including healthcare professionals, patients/consumers, manufacturers, and distributors, have the obligation to directly submit adverse drug reaction (ADR) reports to Health Canada or Marketing Authorization holders.

The Canada Vigilance Program operates through seven regional offices, serving as regional points of contact for health professionals and facilitating the collection of reports from these regions. Subsequently, these reports are forwarded to the Canada Vigilance National Office for thorough analysis. Complementing these efforts, Canada maintains the Canada Vigilance Online Database, encompassing all suspected adverse drug reaction reports.

As a prominent global player, DDReg recognizes the paramount importance of patient safety across the entire spectrum, from clinical trials to post-marketing surveillance of medicinal products. In alignment with this commitment, our safety services portfolio for Canada encompasses end-to-end pharmacovigilance services. 

This includes adverse drug reaction reporting, signal detection and management, aggregate report writing, and the development of customized pharmacovigilance plans/risk management plans, adhering to local requirements and good pharmacovigilance practices.

Who should make this Communication?

• Manufacturer

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk