Health Canada Medical Device Regulations (SOR/98-202)
Instructor:
Winkie Wong
Product ID: 706126
Training Level: Intermediate
- Duration: 90 Min
Why Should You Attend:
- Want to sell your device in Canada but don’t know how?
- Unsure if you have classified your device properly?
- Struggling to understand all of the Regulations in the SOR?
- Struggling to get your device licensed?
- Unsure if your company requires an ISO certificate prior to placing the device into Canada Market?
If you want a comprehensive overview and tips and tricks to organize your Health Canada Registration needs, this course is for you.
This session will not only provide you with the necessary information to place your device in the market but also deliver Checklist and Tools that will help organize your SOPs to ensure better success in Device Registration.
Areas Covered in the Webinar:
- What is a Medical Device
- How to classify your device
- Labeling Requirements
- Manufacturer’s Obligation
- Different ways to bring Medical Devices into the Canadian Market:
- Device Application Requirements and review timeline
- Establishment License Requirements
- Investigational Testing Authorization
- Custom-made/Special Access Devices
Who Will Benefit:
Medical Device Industry Professionals including those involved in
- Product Development
- Operations
- Compliance
- Regulatory Affairs/ Quality
- Marketing
Winkie Wong
Regulatory Affairs, Karl Storz Endoscopy
Winkie Wong is having 12+ Years of Regulatory Experience mainly in Medical Device and also have experience in the OTC drugs, cosmetic and supplement industry.
She has handled, managed and overseen many different product lines and types submissions, including but not limited to, single use and reprocessed surgical instruments, lasers, X-ray, lithotripters, endoscopes, imaging system, etc.
Her main areas of expertise are FDA and Health Canada submissions.
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
