Regulatory Affairs News

24 Jun 2013

New Public Health Institutions

Decree N° 1290/2012 Last September 13, 2012, the creation of the National Agency for Regulation, Control and Sanitary Surveillance (ARCSA) and the National Institute of Public Health Research (INSPI) were published in the Official Gazette Both statutory bodies created within the Ministry of Public Health, will have administrative , economic and financial independence and will […]

24 Jun 2013

New Forms for the Application of Legal Amendments to registered Pharmaceutical

Circular RC-C-005-2012 of the National Institute of Hygiene “Rafael Rangel” On March 5, the National Institute of Hygiene “Rafael Rangel” of Venezuela issued a Circular to the Chambers of Pharmaceutical Industries, Laboratories, Pharmaceutical Representation Houses and Pharmacists acting as Sponsors stating that from March 12th, the legal change applications for pharmaceutical products related to changes […]

24 Jun 2013

Mexican Health Department announces agreement to promote Pharmaceutical Innovation

In order to expand the supply of innovative medicines for Mexican patients and strengthen the competitiveness of the economy, the Ministry of Health through the Federal Commission for Protection against Health Risks (COFEPRIS) announced on October 9 the next entry in force of an important Agreement on the Promotion of Pharmaceutical Innovation. Commissioner Mikel Arriola […]

24 Jun 2013

Importation of Medical Device Parts and Accessories

DIGEMID: Official Notification N° 1356-2012 The official notification has established that Medical Device importers are the ones allowed to import components and accessories of medical products, as long as the same have been registered by DIGEMID or included in the Registration or Renewal Directorial Resolution.

Latin America
24 Jun 2013

Can this product be considered a Medical Device?

Manufacturers of healthcare products, mainly those located outside Latin America often doubt about how their products will be considered in this region. This question is also frequently asked by manufacturers of medical devices, especially by the time a regional business strategy is being discussed. We kindly invite you to read our article that highlights some […]

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