Sanitary Regulations for U.S. Medical Devices 2011

A Lastest News about Dental and Medical Equipment in Mexico

Posted on: 27 Dec 2011

SUMMARY
In January 2011, the Mexican medical device regulatory agency COFEPRIS issued Guidelines for Requesting Marketing Approval for Medical Devices based on Equivalences Recognition with FDA and Health Canada. According to these guidelines, COFEPRIS marketing approvals (sanitary registration) for medical devices already approved by U.S. FDA should be issued within 30 working days if all required documents are submitted.

This procedure is ONLY valid for products approved for sale in the U.S.

GENERAL CONSIDERATIONS
Registration requirements and fees are different according to the risk classification of medical devices. Based on this, COFEPRIS recommends that companies consider carefully the classification of the devices to be registered. To assist companies determine the appropriate classification, COFEPRIS has listed two documents on its website:

“Classification according to sanitary risk and category”
“Criteria for classification according to sanitary risk”

These documents and the guidelines for requesting marketing approval can be consulted in Spanish at:
http://www.cofepris.gob.mx/wb/cfp/equivalencias-en-dispositivos-medicos

It is important to consider that the risk classification for medical devices in Mexico may be different from that used by the FDA. The registration application must contain the right code for the risk classification for the medical devices involved.

The electronic version of the registration application is available at:
http://www.cofepris.gob.mx/wb/cfp/solicitudes2

The list of fees and payment formats are available at:
www.cofepris.gob.mx

REGISTRATION REQUIREMENTS
ALL registration applications must include the following documents:

- Completed application
- Fee payment document
- Copy of the “Facility’s Operation Notification” and Notification of the company’s Regulatory Compliance and Quality Assurance Officer (“Responsable Sanitario”).
These documents must correspond to the company that is requesting the marketing approval and contain the code “S.C.I.A.N.”, which defines the company’s business(industry classification)
- Label project. This document must be in Spanish and comply with the Mexican regulation“NOM-137-SSA1-2008”.
the manufacturer’s, distributor’s, and/or in bond manufacturer’s information must be consistent with the legal documents submitted.
- A user’s manual or operation manual that is necessary for proper use must be included. For foreign manufactured products, the manuals must be translated into Spanish and signed by the company’s Regulatory Compliance and Quality Assurance Officer. Manuals need to include the following information:
Instructive or use manual
o Product description
o List of components or parts
o Purpose of use
o Conditions for conservation and warehousing
o Warnings
o Preparation methods if applicable.
o Cautionary statements
o Warnings, if applicable
o List of adverse events, if applicable
o For contrast media, method of application, pharmaceutical form and drug substance content per dose, as applicable

Operation manual
o Product description
o Applications
o Medical device components or parts
o Assembling and dissembling system, if applicable
o Operation, cleaning and maintenance systems
o Calibration method, if applicable
o Warnings
o Cautionary statements
- Certificate of analysis, including technical and scientific information supporting the safety or efficacy characteristics of the medical device, issued by the product manufacturer, on company letterhead and signed by the manufacturing company’s quality assurance representative. The summary must include the tests performed, the results and the lot numbers of the products representing the various models (when applicable) that were used for the tests.

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Posted: 27 December 2011

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