Medical Devices:

Device means any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in

(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,

(b) restoring, correcting or modifying a body function or the body structure of human beings or animals,

(c) the diagnosis of pregnancy in human beings or animals, or

(d) the care of human beings or animals during pregnancy and at and after birth of the offspring, including care of the offspring, and includes a contraceptive device but does not include a drug;

Canadian Medical Devices Regulations:

Canadian Medical Devices regulations came into effect in 1998. According to the regulations, all medical devices are classified into four separate classes, Class IV being the highest risk class and class I being the lowest risk class. Class I devices are exempt from license while devices classified from class II, III and IV requires pre-market approval. Companies are required to have device and/or establishment licenses to sell the devices.

Quality System Requirements for Medical Devices:

Manufacturer of class II, III and IV devices must be certified to ISO 13485:2003 standards by a CMDCAS (Canadian Medical Devices Conformity Assessment System) recognized registrar.  All new submissions must include an ISO 13485:2003 CMDCAS certificate with the application.

Services Offered:

We at RS Consultant Services can help you in providing expertise to deal with the regulations. We can offer the following services.

Regulatory Affairs:


(a) Submission for class II, III and IV devices license Applications and follow-up with the Medical Devices Bureau to the license approval stage

(b) Submission for clinical investigation of the devices:

(i) Reviewing of information, Providing feedback re: additional information that may be required,

(ii) Preparing submission dossier, Filing with Medical Devices Bureau and responding to the follow-up questions, completing the authorization process of investigational testing

(iii) Good Clinical Practices Auditing

(c) Establishment license Preparation and Approval

(d) SOP preparations:

Preparing procedures according to HPFBI guidelines

(e) Preparing Importer/Distributors for HPFBI inspections

(f) Submission for special Access devices, Custom-Made Devices


(a) 510 k submissions

(b) Registration and Device Listing

ISO 13485:2003:CMDCAS Quality Management System:

Planning for quality management system, help in preparing documentation, working with staff to implement the system, providing training, help with registration process and continuous support and, organizing internal and external audits.

Products Licensed/Investigational Testing Authorization:

The following categories of products have been licensed.  These include class II, III and IV devices.

(a) Cardiovascular Devices – Catheters, Stents, Defibrillator, Hemostasis products

(b) Orthopedic Devices – Implants

(c) Dental Implants

(d) Ophthalmic Devices

(e) Collagen Products/ Aesthetic Devices

(f) Lasers

(g) Imaging Devices

(h) Physical Medicine Devices

(i) Urology Devices

(j) General and Plastic Surgery Devices

(k) Gynecology Devices

(l) In-Vitro Diagnostic Devices