Veraqueconsulting.com

Import permits for Medical Devices in Mexico

A common misunderstanding is that all medical devices with sanitary registration does not require an import permit as well. Even though this type of import permit is only applicable for a … See more

Actived: 8 days ago

URL: https://veraqueconsulting.com/mx/import-permits-for-medical-devices-in-mexico/

Classification and Grouping Ultimate Guide Veraque Mexico

WEBIn addition, the Mexican authorities have established grouping criteria that allow the allocation of similar products in the same sanitary registration. In this guide we present a …

Category: Health Go Health

New amendments in the regulation for Medical Devices in Mexico

WEBAnother key amendment in the Health Supplies regulation is the fact that the renewal process changes. Being more specific, before this update, any sanitary registration in …

Category: Health Go Health

Medical Device Regulatory Overview (Mexico)

WEBMedical Devices in Mexico are regulated by COFEPRIS ( CO misión FE deral para la P rotección contra R iesgos S anitarios), a Federal Commission that belongs to the …

Category: Medical Go Health

Certificate of Free Sales issued by COFEPRIS and requirements

WEBFor medical devices, COFEPRIS issues the Certificate of Support to Export Health Supplies. This certificate is applicable for products meeting the Mexican regulatory …

Category: Medical Go Health

Medical Device Regulatory Affairs Guide for Mexico Veraque

WEBStates that a medical device sanitary registration lasts 5 years. The general law for public administration procedures 2. This document describes the obligations and rights when …

Category: Medical Go Health

Classification and Grouping of Medical Devices in Costa Rica

WEBThe classification of such devices or EMBs is designated based on the level of risk and results in 4 classifications (class I, II, III and IV) based on Chapter II of the Official …

Category: Health Go Health

Regulatory requirements for medical device clinical trials in Mexico

WEBClinical trials in Mexico are regulated in the Federal Law of Health and Regulation from the General Law of Health on Research. Both documents, consider research activities …

Category: Health Go Health

Technovigilance for Medical Devices in Mexico

WEBThe Mexican Official Standard for technovigilance is the NOM-240-SSA-2012 .The aim of this norm is to define how to operate and install a technovigilance program in Mexico. It …

Category: Health Go Health

Software as a Medical Device

WEBAccording to point 5.0 of the above-mentioned document, the term “Software as a Medical Device” (SaMD) is defined as: software intended to be used for one or more medical …

Category: Medical Go Health

Good Manufacturing Practices certificate issued by COFEPRIS

WEBIn Mexico, the Good Manufacturing Practices certificate is applicable to the manufacture of medicines, medical devices or other health supplies manufactured and marketed in the …

Category: Medical, Medicine Go Health

Ultimate Guide for Regulatory Affairs in Costa Rica

WEBAccording to the General Law of Health in Costa Rica, health is considered a public priority and it is protected by the State. For this purpose, the Ministry of Health of Costa Rica …

Category: Health Go Health

MDSAP and how to use it in Mexico

WEBNew guideline for Covid-19 related supplies in Mexico. Location 5ª Cerrada carril de San Agustin. Mz-2 Lt-1 Col. San Jose Buenavista. Cuautitlan Izcalli. State of Mexico. CP. …

Category: Health Go Health

Regístrelo, an on-line registration system in Costa Rica.

WEBSystem Regístrelo is a digital platform developed by the Ministry of Health in Costa Rica that offers companies to apply for a variety of documents fully online. To maintain safety …

Category: Health Go Health

Become a Sanitary Registration Holder in Mexico Veraque

WEBThe ministry of health considers the holder as the main responsible for any affair related to the medical devices the holder owns. The holder is also responsible for complying with …

Category: Medical Go Health

What do you need to transfer your sanitary registration in Mexico

WEBOn the other hand, general requirements to perform such modification are: Updated project label. The public deed where the rights transfer is registered (certified copy or original). …

Category: Health Go Health

Ultimate Guide for Regulatory Affairs in Colombia Veraque

WEBSome of the key regulations related to Medical Devices are: Laws. Law 100 of 1993. Which regulates the origin of the entire system of social security of the country, and which …

Category: Medical Go Health

COFEPRIS keeps its digitalization process through DIGIPRis

WEBAs reported last September 2020, COFEPRIS has kept its digitalization strategy with the solid conviction to optimize the approval process for both medical devices and …

Category: Medical Go Health

What COFEPRIS requires for the Certificate of Free Sale.

WEBThe Certificate of Free Sale (CFS), also known as “Certificate for Export” or “Certificate to Foreign Government”, is a document to evidence that goods, such as medical devices, …

Category: Medical Go Health