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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 Marzo – Webinar RedETSA – Modelo Web de Análisis de Impacto Presupuestario

Nos complace compartir invitación al programa de webinars de la Red de Evaluación de Tecnologías en Salud de las Américas (RedETSA) el día 29 de marzo a las 11am (EST), en la cual el Lic. Alfredo Palacios, del Instituto de Efectividad Clínica y Sanitaria (IECS) hará una presentación sobre “Modelo web de análisis de impacto presupuestario”.

El link de WebEx que utilizaremos es el siguiente: 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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México avança na compra consolidada de vacinas e medicamentos

Foi montado uma mesa de análise para discutir a participação do México nos Fundos Rotatório e Estratégico da OPAS / OMS.

Como membro ativo das Organizações Pan-Americanas e de Saúde Mundial da OPAS / OMS, o México busca a compra direta de certas vacinas e medicamentos por meio de fundos rotário e estratégico dessa organização internacional, dos quais obteria benefícios com relação aos preços oferecidos.

Mais informações pelo link 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 From: Health 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: Ruta consolidada, regular mejor y prohibir menos

El Comisionado Federal para la Protección contra Riesgos Sanitarios, Julio Sánchez y Tépoz, aseguró que al existir una vinculación muy clara entre la salud y el desarrollo de los países, se debe “regular mejor y prohibir menos”, en beneficio de la salud de las personas; “poblaciones fuertes y saludables hacen países más fuertes”, sostuvo.

Más informaciones por el enlace: 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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Equador: Controles da Arcsa deixam mais de 22 mil produtos confiscados em El Oro

Até o momento, neste mês, mais de 22 mil produtos naturais sem o Registro Sanitário do Equador foram confiscados em diversos controles realizados por técnicos da Coordenação Zonal 7 da Agência Nacional de Regulação, Vigilância e Vigilância Sanitária (Arcsa) em diferentes estabelecimentos da região. a província de El Oro, as mesmas que foram retiradas do mercado por pessoal da Unidade de Crimes Aduaneiros da Polícia Nacional (UDAT).

Essas ações são realizadas periodicamente nas dependências de venda de medicamentos e produtos naturais, a fim de verificar a autenticidade do Cadastro Sanitário e o prazo de validade, evitando, assim, a comercialização de produtos que possam colocar em risco a saúde dos cidadãos.

 

Mais informações por link https://www.controlsanitario.gob.ec/controles-de-arcsa-dejan-mas-de-22-mil-productos-decomisados-en-el-oro/

 
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Ecuador: Cancelación de Registro Sanitario de medicamento ABCERTIN (imiglucerasa)

La Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (Arcsa) informa a la ciudadanía que se ha cancelado definitivamente el Registro Sanitario No. 22-MB3-0515 otorgado a la compañía ISU ABXIS CO. LTD., por medio de su representante legal MEDICAMENTA ECUATORIANA S.A., para el medicamento ABCERTIN (imiglucerasa) 200 U POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN.

La acción responde a que se ha verificado que el medicamento no ha sido comercializado por el lapso de un año, razón por la cual la compañía tiene la obligación de retirar las existencias que se mantengan en el mercado general. De igual forma, Arcsa solicita no comercializar, utilizar ni consumir el medicamento ABCERTIN (imiglucerasa) 200 U POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN.

Adicionalmente, se invita a la ciudadanía a informar sobre la venta o distribución de productos sin Registro Sanitario ecuatoriano o que provengan de dudosa procedencia a través de la aplicación “Arcsa Móvil”, o al correo electrónico farmaco.vigilancia@controlsanitario.gob.ec.

Fuente: https://www.controlsanitario.gob.ec/se-informa-sobre-cancelacion-de-registro-sanitario-de-medicamento-abcertin-imiglucerasa/