Global Regulatory Services
Registration and Consulting Services
540-6388 No.3 Road, Richmond, B.C., Canada V6Y 2B3
+1 (604) 370 0166
info@genebiomedical.com
Health Canada
FDA
CE
Certificate (Sample)
FDA stands for the Food and Drug Administration, a government agency responsible for the safety of food, dietary supplements, human drugs, vaccines, blood products, and other biologicals, medical devices, radiation-emitting electronics, cosmetics, veterinarian products, and tobacco products being sold or manufactured in the United States. The FDA also inspects and enforces regulations related to these industries.
Organizations that manufacture, re-pack, or re-label products in the aforementioned industries must register with the FDA, with the exception of cosmetics, where registration is voluntary.
Health Canada
Medical Device Registration in Canada
| Medical Device License (MDL) | Medical Device Establishment License (MDEL) | |
|---|---|---|
| Regulatory Authority | Health Canada | Health Canada |
| Device Class | Classes II III and IV | Manufacturing the Class I devices, and Importers and Distributors of all classes – Class I, II, III and IV. |
| Applicant | Foreign manufacturer | Foreign manufacturer and/or importer/distributor |
| Time frame | Class II – 15 days, Class III – 60 days; Class IV – 75 days | 120 Calendar days |
What are MDL and MDEL?
The MDL (approval license) is an approval of the device, while the MDEL (factory license) is a permit given to the manufacturer/distributor/importer company.
The foreign medical device (class I) manufacturer who intends to sell their medical devices directly to the user in Canada must obtain an MDEL. The manufacturer who intends to sell to the importer on-site must obtain it if he/she is not already in possession of it.
Class II, III and IV medical device manufacturers will also need to prove that they have a certified ISO 13485 quality management system under the Medical Device Single Audit Program (MDSAP).
We can help with applying for FDA/EUA and Health Canada licences for your medical products.
Please fill in the form and we will be in touch shortly.
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