The Medical Device Single Audit Program (MDSAP) allows a recognized Auditing Organization (AO) to conduct a single audit of a medical device manufacturer’s Quality Management System (QMS). It furnishes relevant Regulatory requirements for five countries, i.e., Brazil (ANVISA), USA (FDA), Japan (PMDA), Canada (Health Canada), and Australia (TGA). Aside from the participating Regulatory authorities, several other international partners (the official observers and affiliate members) are involved in the MDSAP.

A Medical Device Establishment Licence (MDEL) is a license issued to Class I medical device manufacturers, importers, or distributors of all device classes. In a recent guidance, Health Canada described how the Agency inspected the licensed medical device establishments, the inspection process and explained how inspectors should assess the compliance with the Food and Drugs Act and Medical Device Regulations.

Mexico is the second-largest market for medical devices in the LATAM region, next to Brazil, and is the import hub for Medical Devices in Latin America. The Medical devices marketed in Mexico are regulated by the Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS), and the regulations are both stringent and complex.

Health Canada has clarified its stand on the research use only testing kits related to COVID-19. Health Canada regulates the import and sale of medical devices and IVDs (In-vitro Diagnostic Devices) in the Canadian market. In the event of the ongoing COVID-19 pandemic and to facilitate the supply of essential medical devices and IVDs, Health Canada has released various Interim Orders for the manufacturers, importers and distributors.

Medical device industry has been a booming industry with new technologies being introduced from time to time and has been dynamic in terms of Regulatory landscape. The year 2020 has seen a major disruption due to the COVID-19 Pandemic and demanded the Health Agencies to gear up for addressing the pressing situation, thus impacting the Agency’s plan of action.

Face shields have gained utmost significance as the primary protective equipment to curb the spread of the COVID-19. Considered as a Personal Protective Equipment (PPE), face shield is made up of a transparent window or visor, that protects the face and associated mucous membranes (eyes, nose and mouth) against the potential exposure to infectious diseases. To guide manufacturers in these rapidly increasing market demands, Health Canada has devised several Regulatory standards and authorization pathways for importing or selling face shields.

Considering the severity of the on-going Covid-19 global pandemic, Health Canada (HC) is consistently warning hand sanitizer manufacturers about the use of the right formulation and ingredients in their products. Recently, the Agency halted 12 hand sanitizer companies from selling their unsanctioned products in the Canada due to the presence of unapproved ingredients. The step was taken by the HC to ensure that only safe and effective products reach the market.

Health Canada (HC) has one of the most stringent regulations for medical devices. To further increase the safety and effectiveness of devices, and optimize the health outcomes for end-users, the Canadian health authority (HA) is aiming to strengthen the current Regulatory framework. The three-part strategy announced recently as an action plan is the part of the same. The aim of the action plan is to take the end-users’ perspective into consideration while developing policies and regulations in future and thus to improve communication.

After a prolonged duration of 18 years, IVD (In vitro Diagnostic) Medical Devices finally fall under the purview of Health Canada’s much awaited finalized labeling guidance. The first draft of this guidance was issued in the year 1998. This guidance emphasizes mainly on: