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.
Our services
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.
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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