South of the Border: Compliance in Mexico, Central America, and South America - In Compliance Magazine

2022-05-28 07:52:41 By :

“Today knowledge has power. It controls access to opportunity and advancement.” – Peter Drucker

In the age of “The Internet of Everything” and an increasingly networked world, our neighbors and trading partners to the south are joining in and demanding access to the same electronic products and associated services that we enjoy in the US and Canada. As the economies in Mexico and the countries of Central and South America grow and develop, so do their wages and middle class populations, becoming an ever-larger source of new customers and profits for global companies and corporations. Those wanting to enter these markets need to understand the legislation, regulations, and certification programs for each.

A good place to start is with the regulatory agencies, which will be discussed in this overview article, along with the basic compliance requirements for ITE and consumer electronics products

We will see many differences in compliance programs, as we look at Mexico, the seven countries in Central America, and the ten largest countries in South America. Some, such as Mexico and Brazil, have comprehensive regulatory compliance programs and modern telecommunications systems in place, similar to the US and Canadian systems, with regulatory requirements for EMC, product safety, wireless, and telecom, and will be covered in more depth. Others have only limited compliance requirements and outdated communications infrastructures, perhaps only concerned with frequency spectrum, and accepting proof of compliance from the regulatory engineering reports of other countries. What they all share in common are citizens that want access to the wealth of information, entertainment, and communication services that are readily available to others, so they can have the opportunity to join in, benefit from, and contribute to our ever-increasingly wired (and wireless) world.

Please note that this article should not be your sole source of information when you begin seeking product approvals. This is just a high-level overview of the national agencies and requirements; the official standards should be obtained for each country, and an experienced regulatory consultant should be utilized if in-house expertise is not available. Also, remember that local customs facilitators can be a valuable source of information on the importation of products.

So let’s get started on our southbound trip, and see if we can map out the path for offering our products to our hemispheric neighbors.

As a NAFTA trading partner, Mexico enjoys economic ties to the US and Canada, and has similar regulatory structures, although with more government involvement. While the US and Canada have worked out Mutual Recognition Agreements (MRA) for the acceptance of regulatory compliance approvals between their countries, the development of a similar agreement with Mexico is still in the beginning stages, so for now electronic product approvals must be obtained from the regulatory bodies for telecommunications and national standards.

www.ift.org.mx/iftweb

The Instituto Federal de Telecomunicaciones (IFT) is the telecom authority of Mexico, translated in English as the Telecommunications Federal Institute. This agency was recently created, in September of 2013, to completely replace the previous telecom agency, the Federal Commission of Telecommunications (COFETEL). As with the previous COFETEL agency, IFT will be the responsible agency for all type approvals for specified telecom equipment imported into Mexico.

IFT will also take over all other agency duties, such as radio frequency spectrum management and assignments for telecommunications and broadcasting, publishing telecom regulations and updates, telecom and broadcast concession grants and transfers, and regulating any telecom or broadcasting monopolies in Mexico. “Grandfathering” does apply to products approved under the previous COFETEL system, with the same previous requirements for displaying the COFETEL homologation number on the product label.

IFT defines the mandatory approval requirements for wireless and telecom products in Mexico, including requirements for product safety. The existing NOM national regulations and approval requirements will continue to be used until IFT publishes replacements.

The typical “PEC” approval process, which is the conformity assessment evaluation process for most consumer electronic products with telecom or wireless features, starts with the receipt of required test samples, which must be tested in authorized labs in Mexico. Under the “traditional” approval process, which applies to specific types of short range wireless devices, no sample testing is needed, and FCC or CE R&TTE reports can be accepted for proof of compliance. The next step is for an authorized Notified Body, such as NYCE or ANCE, to review the test reports and issue a Certificate of Conformity. The final stage is the IFT review, which will issue a Certificate of Homologation, containing an IFT certificate number, which must be displayed on the product label. This entire process typically takes 6 to 8 weeks, but can take much longer depending on seasonal factors, such as in advance of the December holiday selling season.

A local representative is required in Mexico, to serve as an official company representative, and also to retain the original product certifications. This can be a person at a branch office from a company, or a third-party who is registered as a business in Mexico. In either case, the certificate holder must be registered with IFT.

Certificates issued under the PEC program are permanent, as long as the product does not change, but under the traditional program they are only valid for one year, and must be renewed if the product will continue to be sold in Mexico. It is recommended to start the renewal process at least 60 days before the certificate expires.

www.economia.gob.mx/standards/national

Norma Oficial Mexicana (NOM) are the official national standards of Mexico. Each NOM is the official standard that contains the mandatory requirements and regulations for specific types of products or activities.

For electronic products, the NOM standards define and establish minimum product requirements in the areas of product safety, telecom, and EMC, depending on the specific type of device. Beyond these attributes, compulsory requirements for user manual warning statements and packaging labeling requirements are also provided.

These standards are available for free from the referenced NOM website in this article, albeit in Spanish-language. Here are some of the more common NOM standards applicable to consumer electronics:

In Belize, there are only regulatory compliance requirements related to the frequency spectrum and telecommunications infrastructure for most consumer electronics. The Public Utilities Commission is the government agency that grants and regulates telecom and wireless approvals, and in most cases, they will allow regulatory reports from other countries to be submitted as proof of compliance, such as FCC or CE R&TTE compliance reports.

There are no requirements in Belize for local testing, marking/labeling, or a local in-country representative, and the certificate remains valid as long as the product remains unchanged. Approval times can range from 4 to 12 weeks, but typically are completed in less than 6 weeks, if the agency payment is included with the documentation submittal package.

Costa Rica is also mainly concerned about telecommunications equipment and radio frequency spectrum usage. Superintendenci de Telecommunicaciones (SUTEL) is the body that grants and regulates telecom and wireless approvals, and they specifically allow FCC reports and grants to serve as proof of compliance in their country.

A local importer is required in Costa Rica and multiple distributors are allowed. Fully-configured product samples are required for in-country testing, and the software operating system version must be documented, as it will appear on the SUTEL approval certificate. The equipment code listed on the certificate must be printed on the product label, along with the SUTEL logo or name. One unique requirement is for notarized letters for the local representative, product label, product information, and estimated quantities of product to be sold. It is important to consult with an experienced regulatory consultant to verify the specific requirements for your product.

Once issued by SUTEL, the certificate remains valid indefinitely, unless the product design is changed. Approval times are typically 6 to 8 weeks, after the agency has received all of the required documentation and samples, including the notarized letters.

Superintendencia General de Electricidad y Telecomunicaciones (SIGET) is the government regulating body tasked with managing the electricity generation and telecommunications infrastructure and industries in El Salvador, including radio spectrum usage and assignments for the frequencies from 3 KHz to 3000 GHz. SIGET accepts CE R&TTE reports to be submitted as proof of compliance for telecom products, allowing for the importation of products into the country.

In practice, this means that SIGET certification is not required. For example, for a WLAN device operating in the 5 GHz frequency bands, if the product has a CE report showing that it meets the criteria of the R&TTE Directive, then this is accepted as proof of product compliance, allowing registration of the device for use and importation in El Salvador.

The Superintendencia de Telecomunicaciones (SIT) is the high-tech body of the Ministry of Communications, Infrastructure, and Housing. SIT manages and oversees the operation of the radio spectrum and telecommunications register, and is the enforcement agency for the General Telecommunications Law. While the General Telecommunications Law of Guatemala does not specifically require prior approval of electronic equipment that is imported into the country, the SIT approval can be requested by sending a letter of inquiry to the agency, along with the technical specifications for the product.

There are numerous exemptions for most common wireless telecom products; for example, Wi-Fi products used indoors with transmitted power output less than 500 mW can be imported without notifying SIT. However, for transmitting outdoors, especially in regulated bands such as 2.4 GHz and 5.8 GHz, an inquiry should be made to SIT to obtain their ruling on the specific product. In most cases SIT will accept proof of compliance from other countries, such as CE R&TTE compliance reports.

Comison Nacional de Telecomuncaciones (CONATEL) is the national telecommunications commission and regulatory authority of Honduras. CONATEL is a decentralized government agency that issues regulations and technical standards required for telecommunications services and adopts rules concerning the approval of telecommunications equipment and apparatus. While requirements for telecom and product safety compliance are legally required in this country, the CE R&TTE compliance report is allowed to satisfy the telecom for importation, and the CE mark is accepted as proof of product safety compliance.

TELCOR is the Nicaraguan Institute and Regulatory Agency for Telecommunications and Postal Services. Tasked with managing the telecommunications sector, it seeks to encourage technology access for all of its citizens, while ensuring compliance by service and equipment providers. Nicaragua does not have a comprehensive regulatory scheme in place and will allow FCC grants and compliance reports and US Nationally Recognized Test Laboratories (NRTL) certification to serve as proof of product compliance when importing products.

Autoridad Nacional de los Servicios Públicos (ASEP) is the national public services authority in Panama, responsible for water, electricity, and telecommunications infrastructure and services. Our interest lies with the telecom section of this agency, which manages and enforces the telecom equipment requirements, along with management and allocation of the radio frequency spectrum. ASEP recognizes FCC grants and reports to demonstrate compliance for telecom and wireless product certification applications, and a US NRTL certification is allowed to show product safety compliance for importation. The normal timeline for certification is 4 to 6 weeks after ASEP receives all of the required documentation

Our first country in South America has mandatory approval requirements for telecom and product safety, with two separate agencies. Argentina is a modern, Internet-savvy, country with a robust telecommunications infrastructure, and an attractive pool of consumers for electronic devices.

Comision Nacional de Telecomunicaciones (CNC) is the government telecom authority for Argentina. CNC approvals are a mandatory requirement for any device that connects to telephone lines, or that utilize radio frequency spectrum for the transmission of information. CNC publishes standards (Normativa) for each type of regulated product, which can be downloaded for free from their website at this location: www.cnc.gob.ar/infotecnica/homologaciones/normativa.asp

The applicant for CNC approvals must be the local company-authorized importer in Argentina, in order to receive the homologation certificates. The equipment must be tested according to the CNC standards at an authorized in-country test lab; they do not accept foreign test reports, except for allowing FCC or CE compliance test reports for GSM technology. Thus, product samples will be required for these approvals, and the number will depend on the type of product.

Along with the device samples, all of the typical items for a regulatory agency submittal package are required, such as technical specs, user manual, schematics, block diagrams, internal and external photos, and test setup instructions. In addition, the local importer will have to provide signed copies of authorization letters.

After a normal approval cycle of 8 weeks, the CNC certificate will be issued within an additional 4 to 6 weeks. The certificate will remain valid for three years from the date of issue, and must be renewed if the product will continue to be sold in Argentina. CNC requires that the product label contain the company trademark, model number, CNC registration number, and serial number.

Resolution 92/1998 requires all electric and electronic products to be safety certified under IRAM or the international IEC standards. The S-Mark Certification Scheme is the product safety approval to be obtained for ITE and specified consumer electronics products.

In Argentina, the manufacturers or importers, depending on the type of product, can choose one of three categories of certification schemes for products sold in the Argentina Marketplace, as detailed in Resolution 197/2004. The first category is ISO 4, Type certification, where the product is marked based on compliance of IRAM or IEC standards, the certificate number is labeled on the product, and market surveillance is performed on two selected test samples per year, and there is no factory follow-up inspections. Category ISO 5, Mark certification, requires factory quality system evaluation and approval, market surveillance on a product sample once a year, factory follow-up inspections, and a full technical file submittal, including either a CB report or a product sample. And the third option, ISO 7, is Lot certification, where the product is marked based on compliance of IRAM or IEC standards, the lot number and certificate number is labeled on the product, and there is no market surveillance and no factory follow-up inspections.

Autoridad de Telecomunicaciones y Transporte (ATT) is the telecommunications and transportation authority of Bolivia, which recently mandated type approval requirements for wireless and telecom products. Local testing is not required, and FCC or CE R&TTE compliance reports are accepted as proof of compliance, along with the required application letter. An in-country local representative is not required, but an agent registered with the ATT agency must make the application. Factory inspections are not required, nor are there any labeling requirements. The initial estimates are 6 to 8 weeks for receiving approval, starting from the time the agency receives the full submittal package. Once issued, the certificate will be valid for 5 years and can be renewed if needed.

Brazil has mandatory approval requirements for wireless, telecom, EMC, and product safety, with the applicability depending on the specific type of device.

Agencia Nacional de Telecomunicacoes (ANATEL) is the telecom authority in Brazil, responsible for setting the requirements for telecommunication products, including the establishment of authorized bodies for certification and testing activities for EMC, wireless/telecom, product safety, and SAR. Testing must be performed in authorized labs in Brazil, according to the standards, which are called “Resolutions.” The most common of these for consumer electronics and ITE are:

Once the required tests are completed, and a test report generated it is reviewed by an authorized in-country Organismo de Certificacao Designado (OCD), or Designated Certification Body. If the documentation passes review, the OCD will issue a Certificate of Conformity (CoC) which is then submitted to ANATEL, on behalf of the local company representative, along with the complete technical documentation package. Please note that this means a local in-country company representative is required for ANATEL certification. After passing a review by ANATEL, they issue a Certificate of Homologation, which completes the initial approval process. All of this typically takes from 8 to 10 weeks to complete, starting with the receipt of all the required items by the authorized test lab.

While factory inspections are not required, submittal of factory ISO 9001 certificates are required for products that are connected to the telecommunications infrastructure, such as cell phones or fax machines, or when the CoC will list two or more factories. Labels with the ANATEL logo and required certification numbers and assigned bar code must be on each approved product. Depending on the specific type of product, certificates will remain valid for one year, two years, or indefinitely if the product is not changed. Any of the expiring certificates can be renewed, if the product is still sold in the Brazil market.

Instituto Nacional de Metrologia, Normalização e Qualidade Industrial (INMETRO) is the governmental agency that was established to develop and implement the certification system in Brazil. Tasked with maintaining the national standards, INMETRO is also the national developer of conformity assessment programs as well as the main Accreditation Body of certification bodies and laboratories.

INMETRO has mandatory certification requirements for 80 products with potential critical safety impacts, including medical products, hazardous location equipment, electrical cords, circuit breakers, and electrical switches, among others. The approval process is very similar to the ANATEL process, with a requirement to interface with a Product Certification Body (OCP) accredited by INMETRO, and the product testing must be performed by a laboratory from RBLE (Brazilian network of testing laboratories) which are also accredited by INMETRO, in accordance with the ISO/IEC 17025 quality management systems standard for test labs.

Subsecretaria de Telecomunicaciones (SUBTEL) is the telecommunications regulatory agency for Chile, mandating approval requirements for wireless and telecom devices. FCC or CE test reports are accepted as proof of compliance for most products, with the exception of hard-wired devices that connect to the telecommunications network, such as analogue telephones or fax machines, which must be tested in-country.

A local representative is not required, and factory inspections are also not required. There is not a product labeling requirement for wireless devices, however, there is for analogue telephones and printers; for those products the SUBTEL certification number must be on the label, preceded by the acronym “SUBTEL”. The normal approval cycle is 4 to 6 weeks from the time of delivery of the submittal package to the agency, and the certificate has no expiration date, with no need for renewals.

The Comision de Regulacion de Comunicaciones (CRC) is the telecom regulatory commission of Colombia, which has voluntary approvals for all telecom equipment except for products that have voice communication functions, such as mobile phones, and for specific types of satellite communication products. All other products can simply obtain a “Letter of Voluntary Approval” from the CRC, in which they state that the product is exempt from type approval requirements, and may be imported and sold in Colombia, and this letter can usually be prepared by CRC within 2 weeks.

For those products that do require type approvals, note that local testing, factory inspections, product labels, and a local company representative are all not required. FCC grants and reports, or CE R&TTE reports, can be used to obtain the type approvals for these regulated devices. The typical turnaround time for completing the mandatory type approval certification is 4 to 6 weeks, and it has no expiry date, so renewals are not required.

The telecom authority in Ecuador is Superintendencia de Telecomunicaciones (SUPERTEL), and there are mandatory approval requirements for wireless, telecom, and product safety. However, if the output transmit power of any radio device is below 50 mW EIRP, or for any telecom product, approval is voluntary, and voluntary approval letters can be obtained, if desired.

For any type of radio communications product which has an output transmit power higher than 50 mW EIRP, SUPERTEL certifications are mandatory, so product samples are required for in-country testing. Proof of compliance can be shown through other national approvals, such as an FCC grant and report, or EU Notified Body certificate along with the associated test reports.

There are no requirements for factory inspections, local company representatives, or product labeling. Once the certificate is issued, it never expires, so there is no need for certificate renewals. The typical timeline from start to finish is 4 to 6 weeks for approval.

Comision Nacional de Telecomunicaciones (CONATEL) is the national telecommunications commission of Paraguay, which mandates wireless and telecom approvals for products sold in this country. Local testing is not required, and FCC or CE R&TTE reports can be used as proof of compliance with CONATEL. A local company representative is required, and they must have a letter of authority that is issued directly to them by the product manufacturer. Factory inspections and product labeling are not required, but having the FCC mark or CE mark on the label will ensure smoother entry of the product through the customs importation process. The entire approval process will normally take around 8 to 10 weeks, and the certificates are valid for a period of 5 years. Renewals can be submitted at any time prior to or after the expiration date, but if a certificate expires products can not be sold until the renewal certificate is issued.

Ministerio de Transportes y Comunicaciones (MTC) is the Ministry of Transportations and Communications, with mandatory compliance requirements for wireless and telecom products. No factory inspections or in-country representatives are required, nor is in-country testing required, as this agency recognizes FCC or Industry Canada (IC) grants as proof of compliance, which can be submitted with the required submittal documents detailing the company name, brand name, product name, and model number, along with internal and external product photos. The FCC or IC marking must be on the product label, depending on which agency grant was used to obtain approval with MTC. There will not be a certificate issued, as the approval information, including the MTC registration number, is posted on the MTC website. This registration number will be needed by the importer in order to clear customs. These approvals are permanent, making renewals unnecessary, and take from 2 to 4 weeks on average. One exemption to note: if the output transmit power is below 10 mW, and it operates in unlicensed bands, then approval is voluntary.

This country has two regulatory bodies for telecommunications approvals, one for wireless, and the other for hard-wired telecom equipment.

Unidad Reguladora de Servicio de Comunicaciones (URSEC) is the telecommunications regulatory agency of Uruguay, which grants approvals for wireless devices. A local company representative and factory inspections are not required by this agency. URSEC recognizes FCC and CE R&TTE reports as adequate demonstration of product compliance, meaning that no local testing is required. There is no product labeling requirement, but it is highly advised to include the FCC or CE marking on the product, depending on which report the URSEC approval is based on. Approvals typically take about 2 weeks for wireless devices.

www.antel.com.uy/antel

ANTEL is the government-authorized sole telephone company in Uruguay, which serves as the telecom authority for all non-wireless telecom equipment. FCC or CE R&TTE reports can normally be utilized to prove compliance, making local testing unnecessary. Local company representatives are not needed, and factory inspections are not required for ANTEL approvals. While product labeling requirements are not mandatory, it is best to make sure the FCC or CE marking is present on the label, dependent on which agency report was used to show compliance. The ANTEL certificates are valid for five years, and renewals must be submitted prior to the expiration date on the current certificate. The approval timeline is typically around 4 weeks.

Comision Nacional de Telecomunicaciones (CONATEL) is the national telecommunications commission of Venezuela, dictating the mandatory certification requirements for wireless and telecom products. FCC or CE R&TTE reports are accepted as proof of compliance, eliminating the need for local in-country testing. Local company representatives are not required, and neither are factory inspections. CONATEL does not have its own logo labeling requirement, but they do require the FCC or CE mark to appear on the product label, depending on which agency report was used as proof of compliance.

One item to note is that CONATEL will issue a stamped receipt upon receipt of the application package, which the manufacturer can use to start the importation of the product into Venezuela, while it is still in the agency review process at CONATEL. The agency does not provide certificates, instead, the approved products are listed on the CONATEL website. The entire approval process normally takes from 4 to 6 weeks to complete, and once the approval is issued it is permanent, so there is no need for renewals.

We have now followed our path, all the way from Mexico down to the southern tip of South America, but we have not yet completed our journey, for the regulatory compliance landscape is constantly changing, especially in dynamic and growing countries such as these. While we have identified the current regulatory agencies and examined their certification and approval programs, giving us a foundation and review of the requirements in place today, we must stay connected to our own communications networks in the regulatory field, so we can continue to learn and adapt in order to help our companies grow and prosper.

Engineering and regulatory compliance affinity groups are an invaluable resource in staying current on the latest changes to the regulatory compliance standards and processes. The local chapters of the Institute of Electrical and Electronics Engineers (IEEE), such as the IEEE EMC Society and the IEEE Product Safety Engineering Society, provide presentations and opportunities for networking with regulatory compliance engineers on the shifting certification requirements. In addition, social media site Linked In has a wealth of different regulatory compliance related groups that can be joined at no cost, such as the “International Approvals/Certifications” group, where the latest news on country-specific regulatory criteria is shared with other group members.

Mark Maynard is a Director at SIEMIC, a global compliance testing and certification services firm with strategic locations worldwide. He is also an IEEE Senior Member, iNARTE Certified Product Safety Engineer, and a certified Project Management Professional (PMP). Mark holds two degrees from Texas State University, a BS in Mathematics, and a BAAS in Marketing and Business. Prior to SIEMIC, he worked for over 20 years at Dell, in international regulatory compliance and product certifications, with various compliance engineering positions including wireless, telecom, EMC, product safety, and environmental design.

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