Mexico - Apply for Sanitary Registration of Foreign Manufactured Medical Devices

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Procedure

Apply In-Person:

1. To Apply for Sanitary Registration of Foreign Manufactured Medical Devices, 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. 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.
10. This may involve technical evaluations, quality assessments, and safety reviews.
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. Depending on the classification and nature of the device, COFEPRIS might conduct an inspection of your manufacturing facilities to verify compliance with quality standards and regulations.
14. If your application is approved, COFEPRIS will issue a sanitary registration certificate for the medical device. This certificate allows you to market and sell the device in Mexico legally.
15. After receiving the sanitary registration, you'll be required to comply with post-market surveillance, reporting, and other regulatory obligations as specified by COFEPRIS.
16. 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).
• Proof of legal existence of the manufacturer.
• Technical specifications and product information.
• Quality management system certifications (e.g., ISO 13485).
• Clinical evidence or studies if applicable.
• Labeling and instructions for use.
• 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 is eligible to apply for Sanitary Registration of Foreign Manufactured Medical Devices in Mexico if you meet the following requirements:

• The applicant is the manufacturer or authorized representative of the foreign manufacturer.
• The medical devices meet the requirements of the Mexican Ministry of Health (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS).

Fees

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

Validity

• The validity of the license is five years.

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

• Sanitary Registration of Foreign Manufactured Medical Devices in Mexico is the process of obtaining authorization from the Mexican Ministry of Health (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS) to market foreign-manufactured medical devices in Mexico.

Information which might help

• The Sanitary Registration is required for all medical devices that are imported into Mexico, regardless of whether they are manufactured in Mexico or abroad. The purpose of the Sanitary Registration is to ensure that medical devices that are marketed in Mexico meet the safety and effectiveness standards set by the Mexican government.

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

It is important to note that not all foreign-manufactured medical devices are eligible for Sanitary Registration in Mexico. The COFEPRIS may deny registration for medical devices that do not meet the safety and effectiveness standards set by the Mexican government.