Medical Device Single Audit Program (MDSAP) Update

The Medical Device Single Audit Program (MDSAP) Pilot will conclude December 31, 2016.

MDSAP will replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) program, even in situations when a manufacturer intends to sell only in Canada. MDSAP will be the sole mechanism for demonstrating compliance with the quality management system (QMS) requirements of the Medical Device Regulations.

The […]

By |March 30th, 2016|Audits, Medical Devices|0 Comments

Conditional registrations for pesticides

As of June 1, 2016 Health Canada (HC) will no longer issue conditional registrations for pesticides.

Currently conditional registrations may be granted to pesticide products when the scientific review determines that the risks of a pesticide are acceptable, but more information is needed. In this cases, the pesticide is approved prior to the review of additional information.

In future, […]

By |March 28th, 2016|Announcement, Uncategorized|0 Comments

Updated Site License (SL) Guidance Document

The Natural and Non-prescription Health Products Directorate (NNHPD) has posted an updated SL guidance document. Along with the updated guide the Quality Assurance Report (QAR) and Summary of Net Changes (SNC) forms have also been updated.

Important changes to note to the SL review process include:

  • SL renewals will be refused for companies who have not conducted activities in […]
By |March 23rd, 2016|Natural Health Products|0 Comments

Reminder to Generic Drug Manufacturers

Market authorization holders (MAH) of generic drug products regulated under Division 8 of the Food and Drug Regulations are required to file submissions to update their labelling to ensure consistency with that of the Canadian Reference Products (CRP) labeling.

On a monthly basis, Health Canada posts the Product Monograph Brand Safety Updates table. This table displays updates and/or new […]

By |March 7th, 2016|Drugs|0 Comments

Handling Medical Devices Establishment License Audit

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 […]

By |February 24th, 2016|Audits, Medical Devices|0 Comments

DSA Travels to Mexico

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 […]

By |February 18th, 2016|Audits|0 Comments

Change to Ibuprofen listing on the Prescription Drug List

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 […]

By |February 10th, 2016|Drugs|0 Comments

Updates to DEL Applications & GMP Evidence Requirements for APIs

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 […]

By |February 5th, 2016|Announcement, Drugs|0 Comments

What to Look For When Buying a Natural Health Product

As a regulatory consultant for natural health products (NHPs), I get a lot of questions from clients, friends and family on how to differentiate between a NHP and a drug and what to look for when buying a NHP.

With the increasing popularity of healthy living, NHPs are no longer only found in health food stores. […]

By |August 31st, 2015|Natural Health Products|Comments Off on What to Look For When Buying a Natural Health Product

DSA gets timely DEL approval for a Foreign Manufacturing Site

Current Health Canada performance standards are at 250 days for approval of foreign sites.

AuditForeign site approvals require submission of one of the following types of evidence.

  • Regulatory Authority Inspection Report
  • Certificate of GMP Compliance for MRA Countries
  • Corporate or Consultant Audit Report

DSA recently filed a DEL amendment which was […]

By |August 24th, 2015|Announcement, GMP, Regulatory Submissions|Comments Off on DSA gets timely DEL approval for a Foreign Manufacturing Site