Monthly Archives: February 2016

Handling Medical Devices Establishment License Audit

By |February 24th, 2016|

DSA Consultants was recently hired by a local Mississauga firm to handle their Medical Devices Establishment License Audit with Health Canada. The firm is currently licensed as an Importer of Medical Devices into Canada. They were referred to DSA by one of our existing clients.

The first step of the project was to conduct an onsite assessment. We […]

DSA Travels to Mexico

By |February 18th, 2016|

Recently, one of our Senior Quality Consultants was tasked with an audit of a contract manufacturing site in Mexico.

The purpose of the audit was to help prepare the firm for an eventual audit by Health Canada. Our Senior Quality Consultant spent 5 days at the audit site reviewing master production records, stability, validation and other […]

Change to Ibuprofen listing on the Prescription Drug List

By |February 10th, 2016|

Health Canada has announced that certain uses of Ibuprofen will be changed to nonprescription status by amending the Prescription Drug List (PDL). This change only impacts Ibuporfen for human use; the current Veterinary listing will remain the same. The effective date of this change is six months from the date of Health Canada’s notice (February […]

Updates to DEL Applications & GMP Evidence Requirements for APIs

By |February 5th, 2016|

The Active Pharmaceutical Ingredient (API) regulations came into force on November 8, 2013. After a three year transition, November 8, 2016 will mark the full implementation of the Regulations.

Health Canada has posted several updates on changes that have been made to the way API submissions are processed and changes to the GMP evidence requirements of […]