A Notice of Operation in Mexico, or Aviso de Funcionamiento en México, is a document that must be filed with the Mexican Ministry of Health (Cofepris) by any business or person or entity that intends to operate a business that involves the production, distribution, or sale of medical devices, food, beverages, drugs, or other products that could pose a risk to public health.
The Notice of Operation is required in order to obtain a sanitary license, which is necessary to operate a business in the Mexican healthcare sector. There is a fee associated with submitting a notice of operation in Mexico. The fee varies depending on the type of business and the products that will be produced, distributed, or sold.
The following businesses are required to submit a Notice of Operation to COFEPRIS:
Medical device companies
Food and beverage companies
If you are planning to start a business in Mexico that falls into one of these categories, you will need to submit a Notice of Operation to COFEPRIS. Businesses must file a Notice of Operation for each establishment that they operate in Mexico. Businesses must file a Notice of Operation within 30 days of starting operations in Mexico. Businesses must notify COFEPRIS of any changes to their operations, such as changes to their address, hours of operation, or the types of medical devices or health products that they manufacture, import, or distribute. Businesses that fail to file a Notice of Operation or that fail to comply with the other requirements for obtaining a sanitary license may be subject to fines and other penalties.
The notice of operation must include the following information:
The name and address of the business
The type of business activity
A list of the products that will be produced, distributed, or sold
A description of the quality control measures that will be implemented
The name of the responsible person (who must be a qualified professional with experience in the field)
The notice of operation must be submitted to COFEPRIS at least 30 days before the business begins operating. COFEPRIS will then inspect the business to ensure that it meets all applicable health and safety regulations. Once the inspection is complete, COFEPRIS will issue a certificate of operation ( Certificado de Funcionamiento Sanitario ), which must be displayed in a visible location at the business.
How to submit a notice of operation in Mexico
The notice of operation can be submitted to COFEPRIS online or in person at one of its regional offices. To submit the notice of operation online, you will need to create an account on the COFEPRIS website. Once you have created an account, you can log in and complete the online form. To submit the notice of operation in person, you will need to go to one of the COFEPRIS regional offices and fill out a paper form.
To file a Notice of Operation, businesses must submit the following documentation to COFEPRIS:
A completed Notice of Operation form
A copy of the business's business registration certificate
A copy of the business's tax registration certificate - the Mexican Tax Administration Service (SAT).
A copy of the business's sanitary license (if applicable)
A copy of the business's technical documentation for the medical devices or health products that it manufactures, imports, or distributes
The business must have a responsible person who is a qualified professional with experience in the field.
The business must have a quality control system in place.
The business must comply with all applicable health and safety regulations.
Once COFEPRIS has received all of the required documentation, it will review the application and issue a sanitary license if the business meets all of the applicable requirements. The sanitary license is valid for one year and must be renewed annually.
The notice of operation must be renewed every three years. If the business makes any changes to its activities or products, it must notify COFEPRIS within 30 days.
Here are some tips for submitting a Notice of Operation to COFEPRIS:
Make sure that you have all of the required documentation before you submit your Notice of Operation.
Review your Notice of Operation carefully before you submit it to make sure that it is complete and accurate.
Submit your Notice of Operation electronically through the COFEPRIS website.
Follow up with COFEPRIS to make sure that they have received your Notice of Operation and that it is being processed.
If you are a business that manufactures, imports, or distributes medical devices or health products in Mexico, it is important to understand the requirements for filing a Notice of Operation and obtaining a sanitary license. By following the requirements, you can ensure that your business is in compliance with Mexican law and that you are able to operate legally in the Mexican healthcare sector.