(52) 55 63905892

New marketing authorization and extensions

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.

The sanitary registration, in the terms of the General Health Law (Article 368), is a Health Authorization, with which they must count the medicines, narcotics, psychotropic substances and products that contain them; medical equipment, prostheses, orthoses, functional aids, diagnostic agents, consumables for dental use, surgical, healing and hygienic materials, the latter in the terms of article 262, section VI of the General Health Law, as well as pesticides, plant nutrients.

The Generic drugs are characterized by focusing on the following: Requirements and criteria for interchangeability, relationship with the drugs of reference and susceptible medicines to be included in the generic catalogue, interchangeability tests and special tests, as well as Authorized Third Parties to carry out the tests of interchangeability.

The medical devices also called health supplies, can range from a latex glove for Surgeon (healing material), tooth whitening paste (dental supply), Ultrasound equipment (Medical Equipment) to an implant (functional aid), They are used to prevent, diagnose or replace the functioning of some part of the body.
The Plant nutrients are any substance or mixture of substances that contain useful elements for the nutrition and development of plants, growth regulators, soil improvers, inoculants and humectants.

These require a marketing authorization to be manufactured, distributed, marketed or used in our country; This registration is the authorization that the Federal Government grants once the applicant has demonstrated before documented evidence that the product is safe, effective and of quality.

Since 2005, these registers are valid for 5 years and can be renewed in compliance with the provisions established by the Secretariat of Health. The Sanitary Registries can be revoked and revised as established in the General Health Law, Regulation of Health Supplies in which legal, administrative and technical information is included, in accordance with the procedure to be carried out (New Health Registry, modifications and/or renewal). .
Requires marketing authorization
Medical devices

Class I, II and III

Requires marketing authorization
Medicines

Allopathic, herbal, homoeopathic, vitamins, orphan.

Requires marketing authorization
Plant nutrients

Substances involved in the development of plants.

 

Contact

WTC Mexico City

Montecito 38, piso 28, oficina 16.

Phone: CDMX: (52) 55 63905892

Phone: Toluca: 7229481327

E-Mail: contacto@registro-sanitario-regisan.com

Web Site: www.registro-sanitario-regisan.com

Regisan © Gestoría de Asuntos Regulatorios

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