COFEPRIS: DIETARY SUPPLEMENTS

Use a Trusted Partner to Register
Your Dietary Supplements in Mexico

Everything you need to know about Importing Dietary Supplements Into Mexico

Importing and Selling Dietary Supplements in Mexico?

Dietary supplements can be easily imported into Mexico, so long as the proper procedures are closely followed. The government body responsible for authorizing dietary supplements for importation and sale in Mexico is the COFEPRIS (Federal Commission for the Protection Against Sanitary Risks or Comisión Federal para la Protección contra Riesgos Sanitarios).

Do I need to incorporate a local entity to import my dietary supplements?

A local entity such as a limited liability company or corporation in Mexico must process and hold the local dietary supplements registrations with the COFEPRIS – i.e. the Operations Notice (Aviso de Funcionamiento) and Importation Notice (Aviso de Importación). So, in most cases, you will need to incorporate a local entity, unless you have a local distributor in Mexico, who can process the above COFEPRIS registrations on your behalf.

FILE IMPORT NOTIFICATION

FILE OPERATIONS
NOTICE

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What does the dietary supplement registration process in Mexico with COFEPRIS involve?

The process is relatively straightforward. First, a complete list of the products intended for implementation should be compiled along with the products scientific name, commercial name, description and basic product details. Then, using your Mexico legal entity’s electronic signature or e.Firma, the information is uploaded and submitted online via the COFEPRIS online. The approval is generally provided within a few minutes considering that all information is correct. Additional products can be added at any time.

Dietary Supplements and Selling in Mexico?

Ready to get start importing Dietary Supplements and Selling in Mexico?

Get Started Now

Appoint MexInc as Local Legal
Representative in 3 easy steps

If you already have a Mexican Company, you can import dietary supplements in 5 easy steps - really.

- MexInc guides you as to what specific documents are required
- MexInc performs a compliance check to identify the tariff classification and applicable regulations
- MexInc designs the Mexico compliant labeling in Spanish
- Mexinc coordinates all logistics and importation activities so you don’t have to
- MexInc prepares submission dossier and application

If you don’t yet have a Mexican company, appoint MexInc as your local legal representative.

- Have MexInc finalize the incorporation of your local legal entity (Sociedad de Responsabilidad Limitada or Sociedad Anomina).
- Have MexInc obtain your new legal entity’s RFC and e.Firma
- Follow the Dietary Supplements Registrations for the COFEPRIS Operations Notice and Importation Notice
- Let MexInc handle all of your logistics and importation
- Submit your supporting documentation online

Second, for each product to be imported, an importation notification or Aviso de Importación should be obtained. For each individual product the following is required:

Usually, the first-time importation notice is issued within 10 to 15 days in practice. However, times can vary.

What’s the process like for Importing
Dietary Supplements?

The process above is only good for imports performed within a specific period of time and each authorization is good
for only one lot or batch of product. Therefore, the microbiological analysis and laboratory test report needs to match the
specific lot of product actually imported. Once the approval is issued, the importation notice is valid for 30 days
with a single extension available for an additional 30 days for a total of 60 calendar days.

Dietary Supplements
Step	Action	Responsible Party	Key Documents	Typical Timeline	Notes
1	Confirm product classification as suplemento alimenticio	Importer / Regulatory consultant	Product formula, labeling	1–2 days	Ensure it’s not classified as a medicine or novel food.
2	Obtain Free Sale Certificate (CFS) from country of origin	Manufacturer	CFS issued by competent authority	1–4 weeks	Must be apostilled and issued within last 12 months.
3	Translate CFS into Spanish (if not already in Spanish)	Certified translator	Apostilled CFS	2–5 days	COFEPRIS requires official translations.
4	Prepare Aviso de Importación application	Importer / Customs broker	CFS (apostilled & translated), product label, HS code	1–3 days	Make sure label complies with NOM-051.
5	Submit application to COFEPRIS	Importer / Broker	Application form + attachments	5–10 business days	If complete, approval issued quickly; if not, clarification request issued.
6	Receive COFEPRIS approval	COFEPRIS	Approval notice	Same day as issuance	This is the Aviso de Importación document.
7	Arrange shipment & customs clearance	Importer / Broker	Aviso de Importación, commercial invoice, packing list, bill of lading	Depends on logistics	Include Aviso in the customs entry file.
8	Customs clearance	Broker / Customs	Aviso, documents above, NOM compliance proof (if required)	1–3 days	Random inspection possible.
9	Final delivery to warehouse	Importer / Logistics provider	N/A	1–2 days	Product ready for distribution.

Why use MexInc to Import your Dietary Supplements into Mexico?

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