Mexico - Apply for Modification of Technical Medical Devices

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Procedure

Apply In-Person:

1. To Apply for Modification of Technical Medical Devices, the applicant has to approach the Secretaría de Salud 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 is completed, the applicant gets a call from the office regarding the application.
12. For further process, the applicant has to follow the instructions given by the officer.
13. This entire process can be completed within 2 weeks 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).
• Product technical information and specifications.
• Certificates of analysis, quality, or origin.
• Product labeling and packaging information.
• Proof of compliance with relevant standards and regulations.
• Any other documents (If required)

Office Locations & Contacts

Secretaría de Salud.
Avenida Costera Miguel Alemán,
Municipio Acapulco de Juárez 276 Colonia Hornos 39355 Guerrero
Email - [email protected]
Contact link

Eligibility

The applicant is eligible to apply for modification of Technical Medical Devices (TMDs) in Mexico if you meet the following requirements:

• You are the legal manufacturer or importer of the TMD.
• The modification is not a major modification.
• The modification does not change the intended use of the TMD.
• The modification does not increase the risk of harm to patients.

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 2 weeks 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 modification of a Technical Medical Device (TMD) in Mexico is a change to the design, materials, or manufacturing process of a TMD that does not significantly change its intended use.

Information which might help

• The process for obtaining approval for a modification to a TMD in Mexico can be complex and time-consuming. It is important to carefully follow the COFEPRIS regulations and to submit all of the required documentation.

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 examples of modifications that are typically considered to be minor:

• Changes to the labeling or packaging of the TMD.
• Changes to the manufacturing process that do not affect the design or function of the TMD.
• Changes to the software of a medical device that do not affect the safety or effectiveness of the device.