Mexico - Obtain Sanitary Permit or License for the Importation of Medical Devices that Have a Sanitary Registry

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Procedure

Apply In-Person:

1. To Obtain Sanitary Permit or License for the Importation of Medical Devices that Have a Sanitary Registry, the applicant has to approach the Federal Commission for the Protection against Sanitary Risks. link
2. An application form will be provided to the applicant by the concerned officer.
3. The applicant has to fill in all the necessary details in the application form. (Incomplete applications are not accepted)
4. Make sure that the applicant has attached all the necessary documents that are mentioned in the “Required Documents” section of this page.
5. The applicant has to attach the photocopies of the required documents along with the application form while submitting.
6. Submit all the documents with the completed form to the concerned officer.
7. The applicant has to pay the prescribed fee as requested by the authority.
8. After receiving the application, the concerned authority will check the submitted application and document set. If all are in place, the application will be accepted.
9. Some products may require local testing in Mexico to support the registration application.
10. Then the application will be processed further. All the updates on the application status will be sent via SMS to the applicant’s mobile number.
11. Once the process gets completed, the applicant gets a call from the office regarding the application.
12. Once the Sanitary Permit or License is approved, present the permit or license documentation to Mexican customs authorities during the importation process to facilitate customs clearance.
13. This entire process can be completed within 15 days or as per the timeline advised by the respective department authority.

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Required Documents

• Application form
• Identification documents (e.g., passport, national ID card).
• Proof of address (e.g., utility bills, lease agreement).
• Certificate of Sanitary Registry
• Certificate of Free Sale
• Any other documents (If required)

Office Locations & Contacts

Federal Commission for the Protection against Sanitary Risks.
Oklahoma 14 Col. Nápoles 03810 Mexico City
Telephone: 55 5080 5200
Citizen Service: 800 033 50 50
Email - [email protected]
Contact link

Eligibility

The applicant eligible to obtain a Sanitary Permit or License for the Importation of Medical Devices that Have a Sanitary Registry in Mexico if you meet the following requirements:

• You are a legal entity in Mexico.
• You have a physical address in Mexico.
• You have a responsible person who is a certified medical device professional.
• The medical devices you are importing have a sanitary registry in Mexico.

Fees

• The applicant has to pay the prescribed fee as requested by the authority.

Validity

Explain the time until which the certificate/document is valid.
e.g. Birth Certificate Valid Forever

Documents to Use

Please attach documents that can be used by people. e.g. links

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• This entire process can be completed within 15 days or as per the timeline advised by the respective department authority.

Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• Applicants must complete the application form before submitting it. Incomplete applications will not be accepted.
• Applicants must provide genuine information while applying for this procedure.

Required Information

• Name
• Surname
• Address
• ZIP code
• Date of Birth
• Gender
• Mobile number
• Fax
• Email
• Parents name
• Nationality
• Education details
• Mailing address
• Other details
• Declaration
• Date
• Signature

Need for the Document

• A Sanitary Permit or License for the Importation of Medical Devices that Have a Sanitary Registry in Mexico is a document that is issued by the Mexican Ministry of Health (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS) that allows for the import of medical devices that have a sanitary registry in Mexico.
• The permit ensures that the medical devices are imported legally and that they meet the quality standards set by the COFEPRIS.

Information which might help

• The Sanitary Permit or License for the Importation of Medical Devices that Have a Sanitary Registry in Mexico is required for the import of all medical devices that have a sanitary registry in Mexico, including Class I, II, and III medical devices.
• The permit ensures that the medical devices are imported legally and that they meet the quality standards set by the COFEPRIS.

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

link

Others

Here are some of the things to keep in mind when importing medical devices into Mexico:

• The medical devices must be imported from a reputable source.
• The medical devices must be accompanied by the required documentation, such as the sanitary registry and the import permit.
• The medical devices must be stored in a secure location.
• The medical devices must be distributed only to authorized healthcare professionals.