Mexico

Strengthening the local Medical device market

16 Aug 2016
medical devices

By Luisina Laura Lanza

On April 28, 2016, the Joint Ordinary General Assembly for Medical Devices took place in Mexico D.F. organized by the Mexican Pharmaceutical Industry Chamber (CANIFARMA). At this meeting, the medical device market was strengthened between the countries of the Pacific Alliance (Colombia, Chile, Peru and Mexico). It should be emphasized that this regional bloc represents the ninth largest economy in the world.

Representatives of the medical device industry created closer ties between the nations to enhance opportunities in this sector and ensure access to the best health technologies for patients. The main objective is to develop a regulatory framework in order to operate as a single market, to facilitate trade exchange and to increase the leadership position in the production of medical devices by means of the Pacific Alliance.

Medical devices, also called health products, can range from a latex glove (healing material), whitening toothpaste (dental input), ultrasound equipment (medical equipment) to implants (functional support). They are used to prevent, diagnose or substitute the function of any part of the body. In Mexico, these devices have to comply with a sanitary registration in order to be manufactured, distributed, sold or used, as it is the case for several countries around the world. This registration is the authorization granted by the Mexican Federal Government once the applicant has demonstrated through documented evidence that the product is safe, effective and of quality. Since 2005, these registrations are valid for five years and may be renewed in compliance with the provisions established by the Mexican Ministry of Health.

The sanitary recordal can be revoked and revised according to the General Health Law established in the Regulation of Health Products in which legal, administrative and technical information is included, in accordance with the procedure that is to be performed (new sanitary registration, modifications and/or renewal).

The medical device industry has become an engine of the Mexican economy and Mexico is the largest exporter of medical technologies in Latin America.

 

 

Sources:

http://www.cofepris.gob.mx/AS/Paginas/Registros%20Sanitarios/RegistroSanitarioDispositivosMedicos.aspx

http://www.cofepris.gob.mx/Documents/NotasPrincipales/31052016.pdf




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