Health Canada recently announced it is the process of formalizing a meeting framework called "Device Advice: Pre-Clinical Meetings", where medical device manufacturers will be able to receive advice and recommendations for investigational testing protocols.

Investigational Testing Authorization (ITA) issued by Health Canada, allows for the testing of Class II, III, and IV medical devices with human subjects. For unlicensed devices, the submission of an ITA is required to establish new safety and effectiveness data, however, ITAs are also required for licenced medical devices when establishing safety and effectiveness for new indications.

In another move toward global harmonization, by April 1, 2019, medical device manufacturers will be required to submit premarket applications for Class III and Class IV applications in Canada in either the International Medical Device Regulators Forum (IMDRF) table of contents (ToC) format or Health Canada format.

On October 17th, 2018, the long-awaited legalization of cannabis will come into effect.

Health Canada recently announced the development of a draft guidance document to assist medical device manufacturers seeking to license 3D-printed devices.

Health Canada recently announced an update to Guidance Document: Certificate of Supplementary Protection Regulations. The purpose of the guidance is to outline the Certificate of Supplementary Protection (CSP) application process, the service standards, and roles and responsibilities of both applicants and the Therapeutic Products Directorate (TPD).

Neonicotinoids are a class of pesticides used to control insects on a variety of agricultural crops, including seed treatments, and on turf and ornamental plants.

Vanessa’s Law (Protecting Canadians from Unsafe Drugs Act), first enacted in 2014, added section 21.1(3) to Canada’s Food and Drugs Act to permit the Minister of Health to disclose confidential business information about a therapeutic product in certain circumstances. For the first time since the 2014 amendment, a court was called upon to interpret and apply Vanessa’s Law. Doshi v. Canada represents the first such judicial consideration.

The guidance document on Notifying Health Canada of Foreign Actions (the “Guidance Document”) is intended to help Market Authorization Holders (“MAH”) of a Drug Identification Number (“DIN”) or Notice of Compliance (“NOC”) to maintain compliance. Per the Food and Drug Regulations, it is a requirement for a MAH to inform Health Canada of foreign regulatory actions relevant to its products marketed in Canada.

Health Canada recently informed stakeholders, in particular manufacturers and importers of medical devices, of its intent to propose regulatory changes to strengthen post-market surveillance and risk management of medical devices in Canada.

Health Canada has announced that it is initiating the transition to the Global Medical Device Nomenclature (GMDN) as a medical device categorization method. The goal of this initiative is to improve the availability, access, and quality of information available on medical devices in Canada

Antimicrobial resistance is currently recognized as a worldwide public health concern due to difficulty in treatment. In response, Health Canada is preparing to establish new regulatory tools and policies to help expedite the review process of therapeutic products indicated to target such pathogens and better address public health concerns.