If the COVID-19 pandemic made it difficult for customers to receive their goods on time, it certainly made it more complicated to import personal protective equipment (PPE) and medical devices into Canada. Thankfully, as of May 6, Health Canada implemented new regulations to limit extra costs for importers and manufacturers while ensuring public safety.
Here is a Q&A to untangle the latest government regulations on importing PPE and medical devices.
What is considered a PPE or a medical device?
PPE includes Class I products such as sanitizers, face masks, gowns, gloves and face shields. The term “medical device” refers to any product that can be used to prevent, treat, or diagnose a disease or a condition. PPE and testing devices such as swabs are considered medical devices.
What about waivers for customs duties on PPE?
On May 6, Health Canada issued the Certain Goods Remission Order (COVID-19) to offer tariff relief for eligible goods and lower the costs for importing medical supplies, including PPE. Under this order, customs duties for certain products are waived to help Canadian businesses and manufacturers during the COVID-19 pandemic. The detailed list of tariff classifications covered by this order can be found on the CBSA website.
Do I need to change my invoices for sanitizers and face masks?
Yes. Currently, the Canada Border Service Agency is asking importers to mention ‘URGENT – COVID-19’ in their goods’ description for all medical devices being imported to Canada.
What is an MDEL application? Do I need to fill out one?
A Medical Device Establishment Licence (MDEL) allows Class I (low risk) manufacturers, importers, and distributors to import or sell a medical device in Canada. After determining what class of manufacturer you fall under based on the Medical Devices Regulations, you may have to complete the MDEL Application Form (FRM-0292). Some fees may apply.
The following types of businesses are exempted from filling out an MDEL application:
- businesses importing PPE for personal use,
- retailers,
- healthcare facilities,
- certain manufacturers of medical devices, and
- dispensers.
Find out more.
Can my Customs Broker help?
Yes. Our team of customer service representatives can help walk you through the process and answer all your questions. Don’t hesitate to contact us.
Keywords: PPE, medical device, sanitizers, Health Canada, MDEL, tariff relief, face masks, disinfectants, swabs, COVID-19, testing devices, customs duties
