Dell Tech provides Quality Assurance support for regulated products in Canada, including GMP compliance, product release, quality system implementation, and audit preparation. Our experienced QA team helps ensure your operations meet Health Canada’s regulatory standards for manufacturing, packaging, testing, and distribution.
are internationally recognized standards that ensure drugs and natural health products meet the appropriate quality and safety standards for their intended use prior to being sold.
Health Canada inspects establishments that fabricate, package, label, test, import, distribute or wholesale drugs and for some licensable activities active pharmaceutical ingredients (API). GMPs are a requirement under Division 2 of the Food and Drug Regulations.
Issued by Health Canada to sites in Canada that undertake licensable activities with drugs, APIs, vaccines, biologic drugs, radiopharmaceutical drugs, controlled and narcotic drugs, and drugs containing cannabis.
Licensable activities cannot be undertaken at a Canadian building until a DEL is issued.
Storage and transportation are not licensable activities, however, they must be controlled with GMPs.
All foreign sites that undertake licensable activities with the products listed above must be added to the Canadian site DEL and have acceptable GMP compliance evidence/records the activity(ies) completed at the foreign site.
Similar to drugs Good Manufacturing Practices for Natural Health Products is mandated by Health Canada
Ensures safe and efficacious products through:
Responsible for products regulated by Health Canada through directorates in the Branch:
MDSAP allows a manufacturer to have an QMS in place that inspected against the requirements for 5 jurisdictions: Australia, Brazil, Canada, Japan & USA.
An auditing organization recognized by the Medical Device Directorate must issue the ISO / MDSAP certificate
MDSAP requirement is often the limiting factor to a company moving ahead with a device license application to MDD
Medical Device Establishment Licenses are renewed each year on a schedule identical to DEL renewals
From claim substantiation to hazard classification, Dell Tech’s lab services help ensure your product is safe, compliant, and ready for market.
