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Introduction to the Mexican Regulatory System
The Secretariat of Commerce and Industrial Promotion (SECOFI) is the organization that manages and coordinates standardization activities in Mexico. The Mexican regulatory system consists of mandatory standards known as NOMs and voluntary standards known as NMXs. NOMs address the protection of consumer health and safety, commercial information, and the protection of ecology and the environment. NOMs are issued by Mexican Government Secretariats according to the jurisdiction of each one. Any person, either national or foreign, may propose the creation, revision, amendment or cancellation of a Mexican Official Standard. The General Directorate of Standards (DGN) is the administrative unit of SECOFI in charge of receiving these requests and initiating the process. The Mexican Secretariat of Commerce publishes the Program of Standardization listing the mandatory and voluntary Mexican standards that are to be created or revised each year. Nine private sector organizations are accredited to develop standards and/or certify products and/or services in specific fields. Some of these organizations have their own laboratories and perform the entire certification process, or they may work in conjunction with other entities and subcontract third-party laboratories. Other government agencies have their own laboratories in which products are tested to certify compliance with the appropriate NOMs.
Test laboratories are commercial companies responsible for certifying that products meet standards. Laboratory accreditation is currently being turned over to the private sector,
but remains under the supervision of the Government. The Government will authorize one private sector body to grant laboratory accreditation to both calibration and test laboratories; however, if a laboratory accreditation is for the certification of products to a mandatory standard, then the Secretariat responsible for the implementation of the mandatory standard must approve the accreditation. Authorizations as Test Laboratories are valid for two years and can be renewed upon written request. As of January 1998, conformity assessment bodies located in the United States and Canada may apply for accreditation to test products to Mexican standards.
Medical Device NOM Certification Requirements
Mexico currently has few standards for medical devices, but agencies are preparing more standards to be issued in the near future. As of November 1997, Official Standards for medical equipment are:
- NOM-001-SCFI-1993 for ultraviolet & infrared ray apparatus
published in the Official Gazette, October 13, 1993.
- NOM-003-SCFI-1993 for electric massage apparatus, published in
the Official Gazette, October 13, 1993.
- NOM-157-SSA1-1996, for protection and security measures for the
use of diagnostic X-ray equipment, published in the Official
Gazette, September 29, 1997.
- NOM-158-SSA1-1996, for technical specifications for X-ray
medical equipment, published in the Official Gazette, October 20,
Registration with the Secretariat of Health
To be imported into Mexico, all medical or health care products that touch the human body must be registered with the Mexican Secretariat of Health. This registration is required for wound care materials, surgical devices or material, hygienic products, dentistry products, family planning products, implantable prosthesis, diagnostic agents, reagents, medical equipment and instruments, external prosthesis, orthosis and functional aids.
To start the registration process, it is necessary to fill out an application (original and one copy) and present the following documents pertaining to the product, to the manufacturer, and to the manufacturer's representative/distributor in Mexico:
1. Representative/distributor's name, address, and telephone number.
2. Name and address of the institution/company that will prepare or store the product.
3. Name, address (in the country of origin), telephone and fax number of the product manufacturer.
4. Name and signature of the responsible person in Mexico.
5. Copy of one of the following documents pertaining to the Mexican distributor or representative: Operating authorization or certification document or current sanitary authorization or certification of a visit by the Secretariat of Health for verification and authorization.
6. Copy of the authorization of the responsible person from the Mexican distributor/representative's office. (By law, all stores or establishments related to chemical and medical products must have a chemical engineer or physician responsible for their activities).
7. Technical information pertaining the product to demonstrate that it complies with the characteristics and efficiency as authorized in the country of origin. This information must be in Spanish and include:
7.1. Use or purpose.
7.2. Quantitative or percentage formula.
7.3. Technical specifications of the finished product, procedures to evaluate it, and evaluation's results report.
7.4. Sterilization technique used for the product and analytical certificate including the results of the test.
7.5. Clinical information pertaining to the product's safety and effectiveness (if applicable).
7.6. Different product's presentations and/or description of the different packaging systems used (all of them) with test results showing the product keeps sterility in its package (if applicable).
8. Original and copy of the proposed label, in Spanish, according to the correspondent standard, and containing the following data:
8.1. Commercial name of the product
8.2. Product's use and warning legends (if applicable).
8.3. Catalog, lot or serial number (if applicable).
8.4. Sanitary registration number from the Mexican Secretariat of Health.
8.5. Name or business name and address of the manufacturer.
8.6. Name or business name and address of the distributor.
9. Original and copy of the product's manual in Spanish, and the original from the country of origin. Attach catalogs or manuals with the original product presentation.
10. Description of the product's manufacturing process.
11. Description of product's structure, raw materials, parts and function.
12. Document proving application of good manufacturing practices.
13. Laboratory test verifying product's specifications with the signature of the sanitary responsible person in a domestic or foreign institution, including:
13.1. Analytical certificate of the physical-chemical, micro-biological, and biological tests used for the finished product.
13.2. Stability proof (if applicable).
14. Bibliographic references.
15. Domestic or international standard to which the product complies with.
16. Country of origin free sale sanitary documents of the product (FDA authorization in the U.S.)
17. A copy of the Agent/Distributor Agreement, notarized by a Mexican Consular official (if in English, translated into Spanish by an authorized translator). If the importer is a subsidiary of a foreign company, an agent/distributor agreement is only required when the product is not manufactured by the parent company laboratory or manufacturing plant.
18. Certificate for Good Manufacturing Practices issued by the country of origin authority (FDA for the U.S.).
19. Original analysis certificate from the manufacturer, in company's stationary, and signed by the chemical or sanitary responsible.
20. Original and 2 copies of the registration fee payment receipt.
Requestors must get a response to the registration application under the following terms:
- 15 working days, when presenting a positive technical report issued by a third party institution authorized by the Secretariat of Health specifying that the product complies with all the required effectiveness, technical and security conditions.
- 30 working days, for "Class I " products: those that are very well known in the medical practice, with proved effectiveness and safety, and that are not introduced to the human body.
- 35 working days, for "Class II" products: those that are well known in the medical practice, but have a variation in the raw materials of which they are made, or different component concentration, and that are introduced and kept in the human body for less than 30 days.
- 60 working days, for "Class III" products: those new products, products made with new raw materials, or products recently approved in the medical practice, or products that are introduced and kept in the human body for more than 30 days.
If no response is obtained in the specified terms, requestors must understand that the registration is denied, excepting for "Class I" products, where requestors not receiving an answer must understand that the registration is approved.
Registration fees for imported health care and medical products vary from US $300 to US $400 per each product. Current exchange rate is 9.30 pesos per US dollar.
IN ALL CASES THE REGISTRATION, WHEN APPROVED, BELONGS TO THE MANUFACTURER, WHO ALWAYS HAS THE OPTION OF CHANGING DISTRIBUTOR/REPRESENTATIVE IN MEXICO. MANUFACTURERS ARE OBLIGATED TO INFORM THE SECRETARIAT OF HEALTH ON ANY NEW APPOINTMENT FOR DISTRIBUTOR(S) IN MEXICO FOR IMPORTED REGISTERED PRODUCTS.
Labeling for Imports
On November 18, 1998, the Mexican Secretariat of Health published the official standard for labeling of medical devices: NOM-137-SSA1-1995. This standard specifies the information that must be contained in labels of domestic and foreign manufactured medical devices offered to Mexican consumers.
This standard applies to health care materials, diagnostic agents, contrast mediums, dental materials, prosthesis, orthoses, products for hygiene, laboratory kits, laboratory tests, medical instruments, apparatus, equipment, devices and accessories.
According to this standard, labels must include the following information in Spanish:
1. Product name (commercial name of the product). This is the only information that can be in a different language, when necessary.
2. Trademark or logo, name or business name and address of the manufacturer and distributor registered with the Mexican Secretariat of Health.
3. Name and address of the importer.
4. The Country of Origin.
5. The Sanitary Registration number.
6. Expiration date, if the product has a shelf life (sterile quality) of less than five years.
7. Lot or Serial number.
8. Contents, specifying the number of units, volume or weight.
9. Warnings and precautions in the case of toxic products.
10. Use, handling, and care instructions for the products, when they are not obvious. If required, instructions must be attached. In these cases the label must specify: "See attached instructions".
11. For sterile products, state that "sterility is not guaranteed if the original package is broken".
12. Legend specifying that the product is free of toxins or pyrogenes, when applicable.
13. Specification if the product is disposable, if applicable.
14. Manufacturing date. This information may be included where the lot is specified.
15. Nominal dimensions, if applicable.
16. Storage temperature requirements specified such as: ---K(c) to ---K(C), or similar legends.
17. Specific instructions for the disposal of the container, if necessary.
18. Side effects caused by product, if applicable.
19. Ingredients and active elements, if applicable.
20. When a label can not be adhered because of specific reasons or size, the Secretariat of Health will decide what to do.
All information must conform to the product specifications previously approved (registration process) by the Secretariat of Health for each case.
The label may be attached after the product is imported but before sold to consumers. The attached label should not cover the original label.
For bulk products, the information is only required on the bulk container.
The labeling requirements do not apply to:
1. Highly specialized medical equipment.
2. Medical equipment used in commercial, industrial or by service providers and not sold to consumers.
3. Medical equipment imported by persons or institutions for their own use.
4. Medical equipment imported by educational or scientific institutions.
5. Samples of health care products or diagnostic agents imported to be used exclusively for the certification process to comply with Mexican standards.
6. Other medical equipment, when a label can not be adhered because of specific reasons or size. In this situation, the Secretariat of Health will decide the course of action.
7. Other medical equipment, health care products or diagnostic agents determined by the Secretariat of Health.
This information must be on products for retail sale. Listing this information on the container in which a product is packed for shipment will not satisfy the labeling requirement. The above-mentioned requirements also comply with the labeling standard NOM-050-SCFI.
According to the emergency Mexican standard NOM-EM-004-REGNAT-1996 issued on July 5, 1996, because of fitosanitary reasons, all products that are imported inside of a wood box or container or having wood packaging, may be inspected at the point of entry to Mexico.
NOM Certification Requirements
The Secretariat of Health is very active in preparing and issuing standards for medical products.
Updated information on NOMs and other sanitary processes can be found in the web page of the Mexican Secretariat of Health: www.ssa.gob.mx
The basic Mexican import document is the "pedimiento de importacion". This document must be accompanied by a commercial invoice (in Spanish), a bill of lading, and documents
demonstrating guarantee of payment of additional duties for undervalued goods if applicable, and documents demonstrating compliance with Mexican product safety and performance regulations if applicable. Although it is no longer required that a Mexican customs broker prepare and submit the import documentation, use of one is recommended if an importer has not had significant experience in preparing Mexico's import documentation.
NAFTA Certificate of Origin
Under the North American Free Trade Agreement certain products, including most medical devices, that "originate" in Canada, Mexico, or the United States enjoy low or zero tariff rates when traded between these three countries. In order to receive this preferential treatment products that qualify must have a NAFTA certificate of origin. For information on Rules of Origin and the Certificate of Origin see the Trade Information Center website at http://tradeinfo.doc.gov. Click on "country/regional information" followed by "NAFTA (Canada/Mexico); Overview of NAFTA Certificate of Origen/Rules of Origin."
Embassy of the United States of America
Paseo de la Reforma No. 305
06500 Mexico, D.F.
Tel: (011-52-5) 211-0042
Fax: (011-52-5) 207-8938
Contact: Ivan Rios, Standards Attache (ext. 4718)
The Commercial Service helps American companies and business
people export their products to Mexico.
American Chamber of Commerce of Mexico,A.C.
Lucerna No. 78
06600 Mexico, D.F.
Tel: (011-525) 724-3800
Fax: (011-525) 703-2911, 703-3908
Contact: Victor Manuel Moncada, International Trade Director
Non-profit organization which helps American companies
do business in Mexico.
Secretariat of Health
General Coordination for Construction,
Conservation and Equipment
Jose Ma. Izazaga No. 89-11o. Piso
Col. Centro Historico
06080 Mexico, D.F.
Tel: (011-52-5) 709-0356
Tel: (011-52-5) 709-8223 ask for tone
Contact: Lic. Simon Ruiz Rodriguez, Equipment Director
This unit is charge of selecting equipment for the high
speciality health care units of the Secretariat of Health and
also advises state authorities on the equipment they should buy
for the state health care units.
Secretariat of Health
General Directorate for Health Products Control
Mariano Escobedo No. 373, 1er piso
Col. Chapultepec Morales
11570 Mexico, D.F.
Tel: (011-525) 254-7803
Contact: Lic. Jorge Estrada Poumian, Imports Deputy Director
This agency is in charge of controlling and registering the importation of all products related to health care.
Secretariat of Health
General Directorate of Standards, Supervision and Development of the Health Care Services
Insurgentes Sur No. 1397-3er. Piso
Col. Insurgentes Mixcoac
03920 Mexico, D.F.
Tel: (011-52-5) 598-9884, 598-9883
Fax: (011-52-5) 598-1782
Contact; Dra. Georgina Velazquez Diaz, General Director
This unit is in charge of preparing standards to regulate the
manufacturing, trading and use of health care products.
Secretariat of Health
Directorate for Radiologic Risks
Mariano Escobedo No. 366, 4o. Floor
Col. Chapultepec Morales
11570 Mexico, D.F.
Tel: (011-525) 250-4684
Contact: Dra. Marisela Verdejo, Director
This agency is in charge of controlling and registering X-ray
equipment, domestic and imported.
General Directorate of Standards (DGN)
SECOFI-Secretariat of Commerce and Industrial Promotion
Av. Puente de Tecamachalco No. 6
Naucalpan, Edo. de Mexico
Tel. (011-52-5) 729-9300 Exts. 4100-4102/04
Fax. (011-52-5) 729-9484
Contact: Lic. Carmen Quintanilla Madero, Director General
Lic. Ricardo Gonzalez Aguilar, Standards Officer
Ing. Carlos Martinez Nava, Certification Director
This agency authorizes the operation of certification and calibration laboratories and
SECOFI -Secretariat of Commerce and Industrial Promotion
Industry and Foreign Investment
Alfonso Reyes No. 30-13o. Piso
06140 Mexico, D. F.
Tel. (011-52-5) 729-9100 Exts. 4000-4001
Fax. (011-52-5) 729-9322
Contact: Raul Ramos Tercero
Standards Undersecretariat and Director
Mexican Institute of Standardization and Certification (IMNC)
Manuel Ma. Contreras No. 133, 1er Piso
Col. San Rafael
06470 Mexico D.F.
Tel.: (011-52-5) 566-4750/ 535-5872
Fax: (011-52-5) 546-4546
Contact: Dra. Mercedes Irueste Alejandre, General Manager
NORMEX - Mexican Society of Standardization and Certification
Alfredo Nobel No. 21
Centro Industrial Puente de Vigas
54070 Edo. De Mexico
Tel.: (011-52-5) 565-7228
Fax: (011-52-5) 565-7217/ -8601
Contact: Lic. Victor Manuel Terrones, President
Lic. Carlos Sauceda Alvarez, General Director
Mexican Institute for Social Security (IMSS)
Input Technical Control Unit
Jose Urbano Fonseca No. 6
Col. Magdalena de las Salinas
07760 Mexico, D.F.
Tel: (011-525) 754-6629
Fax: (011-525) 754-6463
Contact: Dr. Rodolfo A. De Mucha Macias, Chief of the Unit
This area is in charge of testing and verifying the technical
specifications of all health care products purchased by the IMSS.
Last updated on 5-2-05 by JF
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