ISA HEALTH
International Regulatory Affair Services
Isah Health

Mexico

COFEPRIS

Medical Devices in Mexico, also known as Health Supplies, are intended to be used to prevent or diagnose any disease or supply a body function. These devices must have Sanitary Registration in order to be manufactured, distributed, commercialized or used in Mexican territory. This Registration is the authorization that the Federal Government approves once that is has been proved the safety, efficacy and quality characteristics of the device.

Since 2005 this Registration is valid for 5 years and it can be renewed in accordance with the Mexican Health Regulations.

There are 3 main paths to register Medical Devices in Mexico:

  1. The Regular process, for all kind of devices from any country of origin.
  2. Low Risk Devices Registration. Only for those considered as low risk devices.
  3. The Equivalence Agreement Process. This expedite process can be used for those medical devices approved by USA-FDA, Health Canada or Japanese Ministry of Health.

Medicines, including vaccines are considered important elements for the public Health care. Generic and New Molecules of Alopatic medicines should be registered in Mexico. In order to have safety, efficacy and quality medicines in Mexico the vigilance process starts with the manufacturing activities and continues with storage, distribution and final commercialization.

For this reason, COFEPRIS has implemented an integral regulatory strategy, public health orientated, to control each medicines phases to achieve the public health common goals.

Homeopatic, Vitaminic & Herbal medicines are also regulated and need to comply with the law.

The regulatory frame for Good Manufacturing Practices Certification in Mexico are the following regulations:

  1. NOM-059-SSA1-2206. Good Manufacturing Practices for chemical pharmaceutical industry dedicated to the drugs manufacture.
  2. NOM-164-SSA1-1998. Good Manufacturing Practices for pharmaceuticals.
  3. NOM-241-SSA1-2012. Good Manufacturing Practices for Medical Devices manufacture.

The service that ISA HEALTH offers for Mexican manufacturers is the implementation of the applicable regulation to successfully receive the government inspection in order to get the GMP Certificate from COFEPRIS.

Medical Devices and Medicines that are manufactured in Mexican facilities, require the Free Sales Certificate document for exportation.

The Free Sales Certificate can be obtained from COFEPRIS once the Sanitary Registration has been approved.

For foreign manufacturers, having control of their Medical Devices Registration License in Mexico is an important issue. The device registration needs to be owned by an entity established in Mexico. Foreign manufacturers must maintain a Mexico Registration Holder (RH) or a legal entity (Manufacturers Mexican office) to register and market devices in Mexico.

The RH in Mexico is a person/company responsible for the device registrations, which acts as a liaison between the manufacturer and the Ministry of Health and, in addition to the foreign manufacturer it represents, it is identified on the device registration certificates issued by the Ministry. Any distributors can be added to the same license.

It is highly recommended to appoint an independent in-country representative that specializes in medical device regulatory affairs as the manufacturer’s RH. ISA HEALTH offers this service for MD worldwide manufacturers.

  • COFEPRIS Importation Permits are required for the importation of the following regulated products:
    • Medical Devices (Distribution, Medical Use, Demonstration, Personal Use, between others)
    • Medicines (finished products and raw materials)
    • Food
    • Beverages
    • Cosmetics
    • Dietary Supplements
    • Hazardous Chemicals
  • Advertising permits

    Based on the General Health Law for Publicity of regulated products (Medical Devices, Medicines, Food, Beverages, Cosmetics, Dietary Supplements, Tobacco, Beauty Services & Health Services), it is necessary to have the Advertising Authorization approved in order to start publicity projects of any of the above mentioned products.

Fertilizers & Pesticides in Mexico are regulated by CICOPLAFEST (Ministry of Health, Ministry of Agriculture & Ministry of Environment). The importation, manufacturing and distribution of these products require registration process.

Manufacturing in Mexico of Fertilizers & Pesticides also require Operating License that is obtained with the inspection of the facilities.

Reference: http://www.cofepris.gob.mx