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Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada

March 19, 2019
Our file number: 19-101967-390

Under the Regulatory Review of Drugs and Devices initiative, Health Canada is increasing the efficiency of the regulatory system and supporting timely access to therapeutic products. As part of this initiative, Health Canada is pleased to announce the launch of the e-Learning tool, Understanding How Medical Devices are Regulated in Canada – Premarket Regulation.

This web-based tool, designed as an interactive learning platform, offers an overview of Health Canada’s premarket regulatory requirements for medical devices. It also provides targeted guidance to enable greater consistency in the understanding, interpretation and application of the Food and Drugs Act, the Medical Devices Regulations and their related policies and guidelines.

The tool serves as a valuable, comprehensive, and organized source of premarket regulatory information for various medical device stakeholder groups, including manufacturers, importers, distributors, consultants, healthcare groups, and academia. By providing e-Learning content to  manufacturers and other relevant stakeholders, it is expected that the completeness and quality of Medical Device Licence applications will improve, thereby resulting in more positive, and more timely, regulatory decisions.

Health Canada encourages and invites stakeholders to utilize and benefit from this new educational tool.

Questions or concerns regarding this notice or the e-Learning tool should be directed to the Medical Devices Bureau at hc.mdb.enquiries-enquetes.bmm.sc@canada.ca.

Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/notice-e-learning.html

 
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29 March- Webinar RedETSA in Spanish – Modelo Web de Análisis de Impacto Presupuestario

We would like to share with you the invitation received in its original language (Spanish) to participate in the Health Technology Assessment Network of the Americas (Red de Evaluación de Tecnologías en Salud de las Américas – RedETSA) webinar program on 29 March, 11am (EST) where Alfredo Palacios, Instituto de Efectividad Clínica y Sanitaria (IECS) will discuss the “Web model of budget impact analysis”.

The link that will be used to access this Webinar is available as follows: https://goo.gl/Rxrxki

 
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Chile: Presencia de partículas Cloxinato de Lisina Solución inyectable 100 mg/2 ml

Alerta Farmacéutica 2/19 – Retiro del Mercado

Clonixinato de Lisina Solución Inyectable 100mg/2 mL. (analgésico, antiinflamatorio no esteroidal (Aines)

Serie 75MH1541 – 75ML2081.

Fecha de vencimiento: 08/2021 – 11/2021

Fabricante: Laboratorio Sanderson S.A/Chile

Descripción del defecto: Presencia de partículas, cuyo origen se encuentra en estudio.

más informaciones por el enlace http://www.ispch.cl/sites/default/files/comunicado/2019/02/19-02-2019%20-%20Presencia%20de%20partículas%20clonixinato%20de%20lisina…..pdf

 
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Mexico advances in consolidated procurement of vaccines and medicines

They set up an analysis to discuss Mexico’s participation in the Revolving and Strategic Funds of PAHO / WHO.

As an active member of the PAHO / WHO Pan-American and World Health Organizations, Mexico seeks the direct purchase of certain vaccines and medicines through Revolving and Strategic Funds from these international organizations, from which it would obtain benefits with respect to the prices offered.

For more information go to https://www.gob.mx/cofepris/articulos/mexico-avanza-en-compra-consolidada-de-vacunas-y-medicamentos-186105?idiom=es 

 
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Statement from the Minister of Health on the Regulation of Medical Devices in Canada

Statement

November 29, 2018 – Ottawa, ON – Health Canada

As Minister of Health, protecting the health and safety of Canadians is my top priority. I am deeply concerned by recent reports of serious issues Canadians have been facing with implanted medical devices.

Canada has one of the best regulatory systems in the world for medical devices. Canadians can be confident that the medical devices available in this country have met high standards for safety and efficacy. Health Canada has been taking steps to strengthen its regulation of medical devices, and I have asked that this work be accelerated.

Beyond these existing efforts, however, the Government of Canada agrees that more can be done to further strengthen the oversight of medical devices and to be more open and transparent with Canadians about Health Canada’s regulatory activities. I have directed Health Canada to bring forward an Action Plan to accelerate these efforts on a priority basis and to work with partners on behalf of Canadians.

I have asked the Department to enhance its activities in three key areas:

1. To strengthen processes for the pre-market approvals of medical devices: This will include a review of the policies and scientific requirements for the approval of higher-risk medical devices, including requirements for clinical data. I have also directed Health Canada to take action to enable more medical device research by health professionals, and expand the use of outside medical and scientific experts to advise the Department on medical device issues.

2. To enhance post-market surveillance of medical devices: Working with partners, Health Canada will take steps to improve the reporting of medical device incidents by industry, health professionals and Canadians and make these reports publicly available. The Department will propose new rules requiring that companies inform Health Canada promptly when key foreign regulators issue warnings about a device, so that we can inform Canadians more quickly. The Department will also strengthen its compliance and enforcement activities by modernizing its existing tools and increase its inspection capacity to better identify problems before they affect Canadians.

3. To make the system for medical device approvals and surveillance more transparent: Health Canada will take steps to give Canadians additional information so that they can make better informed decisions about their use of medical devices. The Department will provide summaries of regulatory decisions when it approves more complex medical devices (known as Class III and Class IV devices). Health Canada will also work to improve access to the clinical data that support our authorizations, so that health professionals can better evaluate the benefits and risks of devices for their patients.

The full details of Health Canada’s Action Plan for Medical Devices will be published in the coming weeks.

The world of medical devices is constantly evolving, and the Government of Canada is working to ensure that our regulations and guidance keep pace so that Canadians can have confidence in the medical devices that they need.

The Honourable Ginette Petitpas Taylor, P.C., M.P.

Contacts

Thierry Bélair
Office of Ginette Petitpas Taylor
Minister of Health
613-957-0200

Media Relations
Health Canada
613-957-2983
hc.media.sc@canada.ca

Source: https://www.canada.ca/en/health-canada/news/2018/11/statement-from-the-minister-of-health-on-the-regulation-of-medical-devices-in-canada.html

 
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Cofepris: Consolidated route, regulate better and prohibit less

The Federal Commissioner for Protection against Sanitary Risks, Julio Sánchez and Tépoz, assured that since there is a very clear link between health and development in the countries, it should be “better regulated and less prohibited”, for the benefit of the health of the people; “Strong and healthy populations make countries stronger,” he said.

For more information go to https://www.gob.mx/cofepris/articulos/ruta-consolidada-regular-mejor-y-prohibir-menos-jsyt-183268?idiom=es 

 
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PAHO Job opportunity: Advisor, Noncommunicable Diseases Management

Advisor, Noncommunicable Diseases Management

Grade: P4

Contractual Arrangement: Fixed-Term Appointment

Contract duration: Two years, first year probationary period

Primary Location: United States-Washington, D.C.

Organization: PAHO Department on Noncommunicable Diseases and Mental Health

Schedule: Full-time

 

Application Closing Date: Dec 10, 2018, 5:59:00 PM

 

Job description and application process available online:  https://careers.who.int/careersection/ex/jobdetail.ftl?job=1805658&lang=en

 
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Ecuador: Arcsa controls leave more than 22 thousand products confiscated in El Oro

So far this month, more than 22 thousand natural products without Ecuadorian Sanitary Registry have been confiscated in several controls carried out by technicians of the Zonal Coordination 7 of the National Agency of Health Regulation, Control and Surveillance (Arcsa) in different establishments of the province of El Oro, the same ones that were removed from the market by personnel of the Customs Crimes Unit of the National Police (UDAT).

These actions are carried out periodically in the premises of sale of medicines and natural products in order to verify the authenticity of the Sanitary Registry and expiration date, and thus prevent the commercialization of products that may put the health of citizens at risk.

For more information go to https://www.controlsanitario.gob.ec/controles-de-arcsa-dejan-mas-de-22-mil-productos-decomisados-en-el-oro/

 
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Ecuador: Cancellation of the Registry (marketing authorization) of medication ABCERTIN (imiglucerase)

The National Agency for Health Regulation, Control and Surveillance (Arcsa) informs the public that the Registry (marketing authorization) No. 22-MB3-0515 granted to the company ISU ABXIS CO. Has been definitively canceled. LTD., Through its legal representative MEDICAMENTA ECUATORIANA S.A., for the drug ABCERTIN (imiglucerase) 200 U CONCENTRATE POWDER FOR SOLUTION FOR PERFUSION.

The action responds to the fact that it has been verified that the medication has not been commercialized for a period of one year, which is why the company has the obligation to withdraw the stocks that are kept in the general market. Similarly, Arcsa requests not to commercialize, use or consume the drug ABCERTIN (imiglucerase) 200 U CONCENTRATE POWDER FOR SOLUTION FOR PERFUSION.

Additionally, citizens are invited to report on the sale or distribution of products without an Ecuadorian Health Registry or that come from dubious origin through the application “Arcsa Móvil”, or email farmaco.vigilancia@controlsanitario.gob.ec