Slide +information Labelling Cosmetics Slide +information . Medical devices Slide Authorized representation HOLDER +information Slide +information Review and approval Labelling Slide +information . Technovigilance Slide Pharmacovigilance HOLDER +information

Technovigilance course

In this course you will learn the guidelines for the correct identification and evaluation of the adverse incidents produced by the medical devices in use, based on the NOM-240-SSA1-2012.


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Pharmacovigilance course

In this course you will learn the fundamentals and guidelines of Pharmacovigilance in Mexico, based on NOM-220-SSA1-2016 for the collection, surveillance, research, monitoring and reporting on the adverse effects of medications.


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Our services

Holder - holding (authorized representation)

We offer the authorized representation service (holder or holding) for foreign companies that want to market their products in our country without having to establish a legal entity in Mexico.

New marketing authorization

We plan the integration of all the information required by the Health Authorities for their submission in the time required and for their adequate compliance with the laws, regulations and standards issued by the mexican Authorities.

Modification to marketing authorization

We facilitate the integration of the documents required for the submission of complete and adequate information. We make any change, eg. changes in a manufacturing site, packing material, equivalences of Mexico-US Standard (FDA) or Mexico-Canada in the case of Medical Devices; and amendments, closure of centres, etc.

Product labelling

Our job is to check that the labels of the aforementioned products comply with the regulations in force, verify the necessary corrections and process their approval before the verification unit.

Import and export procedures

We make a prompt request for import and/or export procedures according to the needs of the company.

Advertising notice and permission

We carry out an exhaustive review of the advertising material, as well as the integration of the technical and scientific information for its adequate submission, either to the general public or to medical personnel.

Technovigilance Unit

The purpose Regisan's Technovigilance Unit is to provide support to holders of sanitary registration of medical devices and/or their legal representative in Mexico, to carry out the appropriate surveillance of the devices, in this way guaranteeing the safety of the products and having the protection to patients.

Pharmacovigilance Unit

Regisan's Pharmacovigilance Unit aims to provide support to holders of health records of medical devices and/or their legal representative in Mexico, to perform the proper surveillance of the devices, thus ensuring the safety of the products and having the protection to patients.

Sanitary representative

We provide the sanitary representative that requires your establishment. We determine, based on current regulations, the profile of the person in charge and suggest their activities.

Prescribing information and packaging design/labelling plan

We carry out an exhaustive review of the prescribing information for subsequent submission (for example, information reviewed by the medical area missing the review of the regulatory area or review making comparisons of local information with information sent by the corporations that are in other countries).

Translation of simple documents and by an expert

We have a team of professional translators, specialized in different areas of health. In all our translation services we offer quality and experience.

Operation notice and sanitary license

Establishments with activities related to health issues require notification of operation or sanitary license. We determine the requirements of your case and we process it through Cofepris (mexican authority).

Marketing authorization

Medical devices

They are also called health supplies: class I, II and III.

Medicines

Allopathic, herbal, homoeopathic, vitamins, orphan.

Plant nutrients

Substances involved in the development of plants.

Product labelling

Cosmetics

Cosmetics, perfumery and pre-packaging within the trade.

Food Products

Food supplements, non-alcoholic beverages, pre-packaged products, commercial and health information.

Toys

Bioavailability limits of heavy metals.

Regisan partners around the world

Click on the green areas for more information.

España Francia Alemania Latam

Spain

Our partner: Asphalion Countries: Spain

France

Our partner: Dextreg Countries: France

Germany

Our partner: Asphalion Countries: Germany

Latam

Our partner: Regulaffairs Countries: Latam

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