Establishment Registration with COFEPRIS
 

Una parte importante para comenzar el proceso regulatorio de cualquier producto o servicio ante la COFEPRIS es dar de alta el establecimiento.

Existen dos vías para dar el alta. 

1. Sanitary License

LEGAL BASIS

Health authorization is required for establishments dedicated to:


I. The process of drugs containing narcotic and psychotropic drugs; vaccines; toxoids; sera and antitoxins of animal origin, and blood products

 

II. The elaboration, manufacture or preparation of drugs, pesticides, plant nutrients or toxic or dangerous substances

 

III. The application of pesticides  

 

IV. The use of radiation sources for medical or diagnostic purposes

 

V. Establishments where surgical or obstetric acts are performed and those that provide hemodialysis services.  

 

SAW. Mixing centers for the preparation of parenteral nutritional and drug mixtures.

2. Notice of Operation

LEGAL BASIS

Establishments that do not require sanitary authorization and which, by agreement, shall be determined by the Ministry of Health must give notice of operation.

Aviso de Funcionamiento
Claves SCIAN

Support tools

Differences between both processes:

1. Risk level of the establishment

2. Cost before COFEPRIS

3. Visit of COFEPRIS to begin operation

4. Processing time

Sanitary license

Operation Notice

Tall

It depends on the turn

Yes

Default according to the homoclave of the procedure

Under

Free of charge

DO NOT

Righ now

PROCEDURES WITH WHICH REGULATE CAN SUPPORT YOU

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Products

1. Establishment registration
2. Product registration

Food

Alcoholic drinks

Non-alcoholic beverages

Cosmetics

Food supplements

Cleaning and cleaning products

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Supplies for health

1. Establishment registration
2. Registration of the sanitary manager

  • Pharmacy

  • Apothecaries

  • Medical Device Factory

  • Factory of Herbal Remedies

  • Deposit or Warehouse of Medical Devices

  • Warehouse of medicines (that do not contain biological nor controlled)

Doctor en la computadora
Health services

1. Establishment registration
2. Product registration

  • General office

  • Specialized medicine office