Dermal Distributor Outlet is committed to offering only the highest quality Class 3 medical devices (dermal fillers), ensuring that all products sold have undergone rigorous approval processes by Health Canada.
According to Canadian Law, any entity involved in the sale or distribution of Class 3 medical devices (dermal fillers), must possess a valid Medical Device Establishment License (MDEL) issued by Health Canada. The MDEL is a regulatory requirement designed to ensure the safety, quality, and effectiveness of medical devices available in the Canadian market.
The MDEL license demonstrates that the establishment has met the necessary criteria, including but not limited to quality management systems, risk management, adverse event reporting, and compliance with Good Manufacturing Practices (GMP). It signifies that the establishment has undergone the necessary assessments and inspections to comply with the regulatory standards set forth by Health Canada.
It is essential for companies engaged in the sale or distribution of Class 3 medical devices to obtain and maintain a valid MDEL license. Failure to do so may result in penalties, legal implications, and restrictions on the sale and distribution of medical devices within Canada.
Dermal Distributor Outlet, in collaboration with its manufacturing partners, holds valid Medical Device Establishment Licenses (MDELs) issued by Health Canada, demonstrating their commitment to regulatory compliance and ensuring the sale and distribution of authorized Class 3 medical devices.
Validation of MDEL and Health Canada compliance may be obtained accessing the link below:
Health Canada MDEL Listings
ART FILLER UNIVERSAL
MANUFACTURER: Labratories Fill-Med Manufacturing S.A.
Boulevard Paepsem 18, 1070, Anderlecht, BE
MDEL (Manufacturer): PFAFUN01V1CA
MDEL (Dermal Distributor Outlet): 23703
