Choose Language
China United States United Kingdom South Korea India Pakistan Indonesia Vietnam Canada Japan Argentina France Australia Singapore Egypt

B2B Marketplace | Sign In | Join Free


Mexico Standards

Discussion of any issues related to importing to Mexico.

Mexico Standards

Postby bridgat » Mon Nov 17, 2008 12:41 pm

Standards: Background on NOM's

All products, goods, and services imported into Mexico must comply with any applicable standards and labeling requirements. Mandatory and proposed standards are published by the Mexican Government in the Diario Oficial de la Federacion (Official Gazette) - the Mexican equivalent of the US Federal Register. These are published in the form of a Norma Oficial Mexicana (NOM) (Official Mexican Standard), or a Proyecto de Norma Oficial Mexicana (Proposed Official Mexican Standard).

The minimum comment period for proposed standards is 60 days. During the comment period the public, businesses, or any interested party can submit comments to the address specified in the text of the Proyecto. Comments must be submitted in Spanish and be received no later than the closing date listed in the text of the Proyecto. Comments will be reviewed and responses will be published in the Diario Oficial, indicating whether the comments were accepted or rejected.

There is no set time period in which responses must be issued to comments. If the Government decides to finalize the standard, it will be published as a NOM in the Diario Oficial. Voluntary private sector standards follow the same procedure and are identified with the NMX prefix. The Diario Official is available both in hard copy and electronically.

NOMs are available in English from www.mexicanlaws.com.

Attn: Glenn McBride
MEXICAN LAWS, S.A. DE C.V.
Tijuana, B.C., Mexico

Tels: 664-681-9524, 664-681-2552
Fax: 664-608-9163
glenn@mexicanlaws.com

Standards: Dental Equipment


All medical health products, including dental equipment and supplies, that touch the human body most obtain a registration before the Secretariat of Health.

Labeling: NOM-137-SSA1-1995 lists the labeling regulations for health care products, diagnostic agents and medical equipment whether domestically manufactured or imported. The General Directorate for Health Products Control of the Secretariat of Health is the entity responsible for enforcing standard NOM-137-SSA1-1995.

Standards Certification Requirements

Other than NOM-137-SSA1-1995 no specific Mexican standards apply to dental equipment and supplies.

Import Permits

Some dental equipment and supplies, and under certain circumstances, may require an import permit.

Standards: Detergents and Cleaners


Legal Requirements

Import petitions or accompanying invoices of products classified under items 3402.20.03, 04, 05, and 99 must comply with the following, as published in the Foreign Trade Resolution by Secretaria de Hacienda y Credito Publico (SHCP) - Mexican Ministry of Finance):

1. Include the individual identification data:
a) product presentation;

b) commercial brand name;

c) net content of the container;

d) technical or industrial specifications and final use of product;
and
e) product code, if for retail. Serial number or other specific identification data may be included.

2. The importer must be inscribed in the Ministry of Finance's Specific Sector Lists, household cleaning products in this case.

Labeling

Household cleaning products ready for retail, must comply with NOM-050-SCFI-1994 that provides all the guidelines for commercial information labels. In general, all labeling information is to be in Spanish using the same font size or larger than any other language on the label.

It is extremely important to classify products under the correct HS number, as compliance with NOMs is defined by HS code. For example, NOM-050-SCFI-1994 does not apply for products presented in cartridges or small containers that are for institutional use, part of a manufacturing or an industrial process, or that will be used to render a professional service (including repair/after-sales service workshops). Such products must not be intended for sale to the general public in the way they are imported.

Standards: Key Website


The full text of proposed and enacted standards (NOMs) is available at the library of the Direccion General de Normas (DGN) National Standards Directorate, part of the Secretaria de Economia (SECON) (Ministry of the Economy), or at DGN’s web page: http://www.economia.gob.mx.
Go to 'Lo mas Consultado,' then ‘Catalogo de Normas’ section to search for proposed and enacted standards.

Standards: Labeling of Medicines


The Mexican Ministry of Health published on Monday, April 10, 2000 the Official Mexican Standard (NOM) NOM-072-SSA1-1993 for the labeling of medicines.

U.S. and third-country firms exporting medicines for resale in Mexico must comply with the specifications of NOM-072-SSA1-1993. U.S. firms seeking to export medicines to Mexico are reminded that all medicines must be registered with SSA (Secretariat of Health), and only manufacturers of pharmaceuticals accredited with a sanitary license are allowed to register these products for import and resale in Mexico.

This report provides only a brief summary of NOM-072-SSA1-1993. Full text is downloadable from the Internet: www.ssa.gob.mx/cdi/index.html click on BASE DE DATOS DE NOM'S EN SALUD.

The text contained in the label(s) must be approved by SSA. A draft label is required when applying for SSA's registration. All the information described by this NOM must be complete and in the Spanish language regardless of containing information in other languages. This Mexican Official standard is mandatory for all medicines to be sold in Mexico as well as for medical samples. It does not apply to homeopathic products.

Section 5 of this NOM describes label information. The most important elements are:

1. Brand name
2. Generic name
3. Pharmaceutical form
4. Concentration of the active ingredient
5. Formula stating the word "Formula"
6. The formula declaration must state the generic name of the pharmaceuticals used, their amount, and base equivalent.
7. Dosage
8. Administration via
9. Conservation and storage data
10. Warnings and precautions
11. Sanitary registration code (this code must be exactly as it appears in the SSA's official registration document followed by a roman from I to VI. Being (I) for products that require special permit or prescription by SSA, and (VI) for products sold without restrictions.
12. Lot number
13. Expiration date
14. Manufacturer's data (in this section data for both U.S.
manufacturer and Mexican distributor must be included)
15. Content: units, volume, weight, etc.
16. Maximum retail price
17. Secondary containers
17.1. Brand name
17.2. Generic name
17.3. Pharmaceutical form
17.4. Concentration
17.5. Content description
17.6. Formula
18. The rest of the information described in sections 5 and 6 of the standard must be distributed all over the surface.
19. If product comes only in one container, this must include all of the information.
20. Label for small containers (ampoules, flasks up to 5 ml, sachets, pre-filled syringes, etc.), and collective or additional packaging is further described in the NOM.
21. When there is information in a language other than Spanish, they must correspond in content size and font type.
22. In no case will it be permitted to cover the original information with a sticker without SSA's authorization.

Warning and precaution legends in Spanish that must appear according to the type of products specified in item 11 of this report.

Medicines may include a leaflet with instructions when these cannot fit into the labeling area, and are required by the nature of its handling, use, or preparation.

NOM-072 also provides the specific data for medicines distributed by the public sector and the GI (Generico Intercambiable - Exchangeable Generic) line.

SSA published on August 17, 1998 the catalog of pharmaceutical products approved for sale under the GI line. This catalog was followed by five updates, as of this writing. The list includes pharmaceutical form, registration code, and manufacturer for each approved product. To include a product as a GI it must prove its bio-equivalence. SSA published on May 7, 1999 NOM-177-SSA1-1998 that sets the criteria for accredited firms that perform this exchangeability tests.

Standards: Product Certification Regulations


On February 29, 2000, Mexico published product certification procedures that allow U.S. manufacturers to directly obtain certification that their products comply with official Mexican regulations. The February 29 publication only reflects the modifications to the existing procedures. The full text of the Product Certification Procedures (including modifications to existing procedures (2/29/00, in English - unofficial translation and existing procedures in English -unofficial translation) is available on the Department of Commerce's Industry Consultation Program (ICP) web page at: http://www.ita.doc.gov/icp/comments.html

Background

Prior to the publication, only Mexican producers or importers were allowed to obtain a Norma Oficial Mexicana (NOM) certificate (official document certifying that a particular good complies with applicable standards). U.S. companies with multiple Mexican importers had to duplicate the certification costs. Under the revised procedures, a U.S. manufacturer can supply numerous importers without duplicating the cost of testing and certification.

The publication also includes provisions regarding the verification of the truthfulness of labels for products subject to NOM-051-SCFI-1994 for prepackaged foods and non-alcoholic beverages.

Standards: Telecommunications Interface


The Federal Telecommunications Commission COFETEL (Comision Federal de Telecomunicaciones) published in the Official Gazette a new mandatory standard (NOM) for Telecommunications Interface - Integrated Services User Part of Common Channel Signaling (ISDN-UP). NOM stands for Norma Oficial Mexicana (official Mexican standard).

The following information is a summary of the standard. It is important to note that this is not an official translation and only the actual Official Gazette text can be used as the legal document.


STANDARD CODE: NOM-112-SCT1-1999

STANDARD NAME: Telecomunicaciones - Interfaz - Parte de Usuario de Servicios Integrados del Sistema de Señalizacion por Canal Comun. Telecommunications Interface - Integrated Services User Part of Common Channel Signaling

STANDARD TYPE: Definite

EFFECTIVE DATE: JULY 21, 2000

INTERNATIONAL STANDARD EQUIVALENT: This standard is equivalent to the international recommendation Q.767 of the International Telecommunications Union (ITU), published in Spanish on February 1991. A copy of this recommendation can be obtained on the ITU web site at: www.itu.int.itudoc/itu-t/rec/q/index.html


OBJECTIVE: This standard defines the Integrated Services Digital Network User Part (ISDN-UP) by specifying the signaling messages of the Integrated Services Digital Network (ISDN), its encoding and signaling procedures and its characteristics while through a telephone central on any telecommunications network.

The ISDN-UP is the Signaling System Protocol No.7 (SS7) which provides the necessary signaling functions to support basic carrier services as well as supplementary services for voice and data and video applications in any Integrated Services Digital Network (ISDN).

The ISDN-UP utilizes the services provided by the Message Transfer Part (MTP) for the information transfer between the ISDN-UP. This last part of Message transference is specified in NOM-111-SCT1.

This standard applies as signaling interface between any national telecommunications public network. The ISDN-UP is also appropriate for its use in any specialized telephone networks and switched circuit data networks, as well as analog and mixed (analog/digital) networks. The ISDN-Up specially satisfies the requirements for switched circuit voice traffic and automatic and semi-automatic telephony between telecommunications public networks.

APPLICATION AREAS: This standard is applicable to all telecommunications operators that require interconnecting their networks to a Public Telecommunications Network.

Standards: Two New Telecommunications Standards

Telecommunications Standards


The following information is a summary of the standards. It is important to note that this is not an official translation and only the actual Official Gazette text can be used as the legal document.

Telecommunications Terminal Equipment. Standard code: NOM-151-SCTL-1999

Standard name: Interfaz a Redes Publicas para Equipos Terminales. (Public Network Interface for
Terminal Equipment)

Standard type: Definite

Effective date: November 20, 1999

International Standard Equivalent: There is no concordance with any international standards as there are no references available at the moment the standard was done.

Objective: This standard establishes the mechanical and electrical conditions and the test methods of the
minimum technical parameters that any terminal equipment connected to a public telecommunications
network must comply.

Application Areas: This standard is applicable to all kinds of terminal equipment connected or interconnected through a wired access to the connection point of a public telecommunications network. It is also applicable to wireless terminal equipment that uses radio frequency bands to link a portable equipment with its fixed base connected or interconnected through a wired access to the connection point of a public telecommunications network.
Telecommunications Interface Standard

Standard Code: NOM-152-SCTL-1999

Standard Name: Interfaz Digital a redes Publicas -Interfaz a 2,048 kbit/s. (Digital Interface to Public
Network - digital interface at 2,048kbps)

Standard Type: Definite

Effective Date: November 20, 1999

International Standard Equivalent: This standard fully coincides with paragraphs 2.3 and 5.1 of recommendations G.704 and G.823 of the International Telecommunications Union.(ITU). This standard
basically coincides with Paragraph 6, Recommendation G.703 of the ITU.

Objective: This standard establishes the minimum technical parameters that any digital interface at
2,048 kbps, also known as el, must use to interconnect telecommunications networks among telecommunications operators.

Application areas: This standard is applicable to all telecommunications operators that require interconnecting their networks to a public telecommunications network.

For a complete copy of the standards text visit:
www.cronos.cta.com.mx/normas/kdocs/1999/151sctl.doc

And:
www.cronos.cta.com.mx/normas/kdocs/1999/152sctl.doc

For more information on these standards and other telecommunications standards visit: www.cofetel.gob.mx

And www.economia.gob.mx

Standards: Vehicle Emissions Control



Standards

Currently, there are 10 emissions standards (environmental norms), known as NOM's, for mobile sources. U.S manufacturers of vehicle emissions control technologies must follow the standard to be able to market their products in Mexico. The standard does not include the type of materials or dimensions that must be used to manufacture vehicle emissions control technologies but does specify the technical specifications which have to be met by the products to be imported and certified by a Mexican laboratory. The December 28, 1995 decree provides a list of product categories by Mexican tariff number which are subject to NOM's, but this list is not all-inclusive. A clarification and update of this list was published on June 28, 1996. The following are the NOM's on emissions standards:

NOM-041-ECOL-1996
NOM-042-ECOL-1993
NOM-044-ECOL-1993
NOM-045-ECOL-1993
NOM-047-ECOL-1993
NOM-048-ECOL-1993
NOM-049-ECOL-1993
NOM-050-ECOL-1993
NOM-076-ECOL-1995


Labeling Regulations

According to the Ministry of Commerce and Industrial Development (SECOFI) (now known as the Ministry of the Economy or SECON) June 2, 1997 decree imported products must meet Mexican labeling regulations. Vehicle emissions control technology must bear the following commercial information in the Spanish language:

I. Name of the product;

II. Name and address of business or person importing;

III. Net contents, in accordance with the Mexican Official Norm NOM-030-SCFI-1993, published in the "Diario Oficial" October 29, 1993, independent of being expressed in other units of measure;

IV. Warnings or cautions in case of dangerous products, in accordance with Official Mexican Norms and other current regulations;

V. Directions on how to use, handle and preserve the product, as appropriate.
bridgat
 
Posts: 1180
Joined: Thu Nov 13, 2008 12:51 am

Return to Mexico

Who is online

Users browsing this forum: No registered users and 0 guests

cron